Makoto Naganuma

University of Virginia, Charlottesville, Virginia, United States

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Publications (94)431.32 Total impact

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    ABSTRACT: Fecal microbiota transplantation (FMT) is a treatment to restore the normal microbial composition of the gut by introducing fecal microbiota obtained from a healthy donor into a diseased individual. There has been a growing interest in the use of FMT as a treatment of various diseases including Clostridium difficile infection (CDI), inflammatory bowel disease, and irritable bowel syndrome. Despite the increasing application of FMT, there are no standard protocols. Many aspects of FMT procedures vary regarding donor selection, preparation of fecal materials, recipient preparation, and route of administration. FMT is most successful in treating recurrent CDI. A randomized controlled trial reported a success rate of approximaetly 90%. Ulcerative colitis (UC) is a potentially good indication for FMT, although limited evidence is available on the use of FMT for the treatment of UC. Only several small case series have been reported, and the results in terms of efficacy are inconsistent. FMT can also be used to treat diseases other than gastrointestinal disorders in which the gut microbiota is disturbed, e.g., cardiovascular diseases, autoimmune diseases, and metabolic disorders. There remain many unanswered questions with regard to FMT, and more research is required in this field.
    The Keio Journal of Medicine 12/2014;
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    ABSTRACT: Background & Aims: Behçet’s disease is a chronic, relapsing inflammatory disease that can involve the mouth, skin, eyes, genitals, and intestines. Active intestinal Behçet’s disease can be complicated by gastrointestinal (GI) bleeding and perforation. We performed a multicenter, open-label, uncontrolled study to evaluate the efficacy and safety of adalimumab, a fully human monoclonal antibody against tumor necrosis factor ɑ, in patients with intestinal Behçet’s disease who were refractory to corticosteroid and/or immunomodulator therapies. Methods The study was conducted at 12 sites in Japan, from November 2010 through October 2012. Twenty patients were given 160 mg adalimumab at the start of the study and 80 mg 2 weeks later, followed by 40 mg every other week for 52 weeks; for some patients, the dose was increased to 80 mg every other week. A composite efficacy index, combining GI symptom and endoscopic assessments, was used to evaluate efficacy. The primary efficacy endpoint was the percentage of patients with scores of ≤1 for GI symptom and endoscopic assessments at week 24. Secondary endpoints included complete remission and resolution of non-GI Behçet’s-related symptoms. Results Nine patients (45%) had GI symptom and endoscopic assessment scores ≤1 at week 24 of treatment, and 12 patients (60%) had these scores by week 52. Four patients (20%) achieved complete remission at weeks 24 and 52. Individual global GI symptom and endoscopic scores improved for most patients at weeks 24 and 52. Two-thirds of patients with oral aphthous ulcers, skin symptoms, and genital ulcers and 88% of patients with erythema nodosum had complete resolution of these conditions at week 52. A total of 9/13 patients (69%) taking steroids at baseline were able to taper (n=1) or completely discontinue steroids (n=8) during the study. No new safety signals were observed. Conclusions Adalimumab is a potentially effective treatment for intestinal Behçet’s disease in Japanese patients who are refractory to conventional treatments. ClinicalTrials.gov number: NCT01243671.
    Clinical Gastroenterology and Hepatology. 09/2014;
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    ABSTRACT: Magnetic resonance enterography (MRE) has been reported to be a useful modality for the evaluation of luminal inflammation and extraintestinal complications in Crohn's disease (CD). A recent study indicated that the diagnostic ability of MRE was comparable to the diagnostic ability of other devices, such as ileocolonoscopy. MRE can be performed repeatedly because there is no radiation exposure. Therefore, MRE is useful as a method of follow-up for younger patients with established CD. It is useful for evaluating the efficacy of medical treatments, such as biologics. MRE can detect small intestinal lesions even if the endoscope does not pass through the stenosis. The concerns of availability of expertise and the costs associated with MRE should be addressed so MRE can be widely used for CD patients in the near future.
    Expert review of gastroenterology & hepatology. 09/2014;
  • Naoki Hosoe, Makoto Naganuma, Haruhiko Ogata
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    ABSTRACT: More than a decade has passed since small-bowel capsule endoscopy (CE) was first reported. Small-bowel CE is a noninvasive tool that allows visualization of the entire small-intestinal mucosa and facilitates detection of small-intestinal abnormalities. Several studies have shown benefit of small-bowel CE for certain disorders. Because it is noninvasive, CE has been applied in other organs including esophagus, stomach, and colon. The main indications for esophageal CE (ECE) are screening for gastroesophageal reflux disease (GERD)/Barrett's esophagus and esophageal varices. However, the clinical benefit of ECE is unconfirmed. Magnetically guided CE (MGCE) was developed to visualize the gastric mucosa. MGCE is a new concept with room for improvement of the capsule navigation and preparation protocol. Recently, two new small-bowel CE tools were released. The first-generation colon CE (CCE-1) has a moderate sensitivity and specificity compared with colonoscopy for colorectal neoplasia surveillance. To obtain higher accuracy, a second-generation CCE (CCE-2) was developed with a high sensitivity for detecting clinically relevant polypoid lesions. A possible application of CCE is for inflammatory bowel disease. In the near future, CE may include diagnostic and therapeutic functions such as a magnifying endoscopy system, targeted biopsy forceps, and drug delivery system.
    Digestive Endoscopy 09/2014; · 1.61 Impact Factor
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    ABSTRACT: The incidence and prevalence of inflammatory bowel diseases (IBDs) including ulcerative colitis and Crohn disease are rapidly increasing in Western countries and in developed Asian countries. Although biologic agents targeting the immune system have been effective in patients with IBD, cessation of treatment leads to relapse in the majority of patients, suggesting that intrinsic immune dysregulation is an effect, not a cause, of IBD. Dramatic changes in the environment, resulting in the dysregulated composition of intestinal microbiota or dysbiosis, may be associated with the fundamental causes of IBD. Japan now has upgraded water supply and sewerage systems, as well as dietary habits and antibiotic overuse that are similar to such features found in developed Western countries. The purpose of this review article was to describe the association of diet, particularly Japanese food and microbiota, with IBD.
    The Korean Journal of Internal Medicine 07/2014; 29(4):409-415.
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    ABSTRACT: The methods of evaluating endoscopic mucosal findings and the definition of mucosal healing in inflammatory bowel disease have not been standardized.
    Journal of Crohn s and Colitis 06/2014; · 3.39 Impact Factor
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    ABSTRACT: Behçet's disease (BD) is a chronic relapsing disease with multiple organ system involvement characterized clinically by oral and genital aphthae, cutaneous lesions, and ophthalmological, neurological, and/or gastrointestinal manifestations. Little clinical evidence is available regarding the management of patients with intestinal BD, despite recognition that the presence of intestinal lesions is a poor prognostic factor, causing perforation and massive bleeding. Many recent case reports have suggested that anti-tumor necrosis factor alpha (TNF)α monoclonal antibodies (mAbs) are effective in patients with intestinal BD. Adalimumab, a fully human anti-TNFα mAb, has been approved in Japan for the treatment of intestinal BD. Here, we review the pathogenesis, diagnosis and management of intestinal BD, including evidence of the efficacy of anti-TNFα mAbs.
    Clinical Journal of Gastroenterology 06/2014; 7:205-212.
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    ABSTRACT: Adenosine is a purine metabolite that can mediate anti-inflammatory responses in the digestive tract through the A2A adenosine Receptor (A2AAR). Here we examined the role of this receptor in the control of inflammation in the adoptive transfer model of colitis. Infection of A2AAR(-/-) mice with Helicobacter hepaticus increased colonic inflammation scores compared to uninfected A2AAR controls. Comparison of T cell subsets in wildtype and A2AAR(-/-) mice revealed differences in markers associated with activated helper T (Th) cells and Treg. Past studies have shown that expression of A2AAR on CD45RB(HI) and CD45RB(LO) Th cells is essential for the proper regulation of colonic inflammation. Adoptive transfer of CD45RB(HI) with CD45RB(LO) from wildtype mice into RAG1(-/-)/A2AAR(-/-) mice induced severe disease within 3 weeks, although transfer of the same subsets into RAG1(-/-) mice does not induce colitis. This suggests that the presence of A2AAR on recipient cells is also important for controlling colitis. To investigate the role of A2AAR on myeloid cells, chimeric recipients were generated by giving RAG1(-/-) or RAG1(-/-)/A2AAR(-/-) bone marrow to irradiated RAG1(-/-) mice. After adoptive transfer, these recipients did not develop colitis regardless of the A2AAR expression by the donor. Together, our results suggest that the control of inflammation in vivo is dependent on A2AAR signaling through multiple cell types that collaborate in the regulation of colitis by responding to extracellular adenosine.
    American journal of physiology. Gastrointestinal and liver physiology. 05/2014;
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    ABSTRACT: Background and Aims: Infliximab (IFX) is a monoclonal antibody used to treat patients with Crohn's disease (CD). Intra-abdominal abscess formation is a major complication of CD with negative effects on patient prognosis. We have analyzed risk factors for abscess formation in CD patients treated with IFX. Methods: CD patients who received IFX between January 2000 and April 2011 at Keio University Hospital were analyzed retrospectively. Risk factors for abscess formation were assessed by univariate and multivariate logistic regression analyses. Results: Intra-abdominal abscess was seen in 15 of 258 patients. Univariate analyses showed serum C-reactive protein (CRP) concentration at 14 weeks after initiation of IFX (p = 0.021), serum albumin concentration at week 0 (p = 0.022) and week 14 (p = 0.004), the presence of anal lesions (p = 0.036), progression of intestine deformation (p = 0.015) and early loss of response to IFX (p < 0.0001) to be risk factors. Multivariate analysis showed that CRP concentration at 14 weeks [odds ratio (OR) 1.361] and loss of IFX response within 6 months (OR 5.361) were independent risk factors. Conclusions: Abscess formation should be suspected in patients with symptoms of CD recurrence during IFX therapy. Uncontrolled CRP concentration and early loss of response to IFX are risk factors. © 2014 S. Karger AG, Basel.
    Digestion 05/2014; 89(3):201-208. · 1.94 Impact Factor
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    ABSTRACT: & Aims: Magnetic resonance (MR) enterography is a recommended imaging technique for detecting intestinal involvement in Crohn's disease (CD). However, the diagnostic accuracy of MR enterograpy has not been compared directly what that of enteroscopy of the jejunum and proximal ileum. We evaluated the usefulness of MR enterocolonography (MREC) by comparing its findings with those from balloon-assisted enteroscopy. In a prospective study, MREC and enteroscopy were performed within 3 days of each other on 100 patients. Ulcerative lesions and all mucosal lesions were evaluated. Physicians and radiologists were blinded to results from other studies. Findings from MREC were directly compared with those from enteroscopy; the sensitivity and specificity with which MREC detected CD lesions were assessed. MREC detected ulcerative lesions and all mucosal lesions in the small intestine with 82.4% sensitivity (95% confidence interval [CI], 75.4%-87.7%) and 67.5% sensitivity (95% CI, 63.1%-70.0%), respectively; specificity values were 87.6% (95% CI, 83.7%-90.6%) and 94.8% (95% CI, 90.1%-97.5%), respectively. MREC detected major stenosis with 58.8% sensitivity (95% CI, 37.6%-77.2%) and 90.0% specificity (95% CI, 88.4%-91.5%) and all stenoses with 40.8% sensitivity (95% CI, 30.8%-49.4%) and 93.7% specificity (95% CI, 91.1-95.9%). MREC is useful for detecting active lesions in the small intestine. However, MR imaging is less sensitive for detecting intestinal damage, such as stenoses. Enteroscopy is preferred for identifying intestinal damage. Suitable imaging approaches should be selected to assess CD lesions in deep small intestine.
    Gastroenterology 04/2014; · 12.82 Impact Factor
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    ABSTRACT: We have reported that second-generation colon capsule endoscopy (CCE-2) might be feasible for assessing the severity of mucosal inflammation in ulcerative colitis (UC). However, because of the low rate (69%) of complete evaluation of the colon and owing to inadequate cleansing. We believe that the method of bowel preparation could be improved by reducing volume. In the present study, we attempted to improve the colon-cleansing regimen in order to optimize the usefulness of CCE-2 in the management of UC patients. Twenty patients with histologically confirmed UC were enrolled. Patients took a maximum 2.2 L lavage solution (polyethylene glycol solution and magnesium citrate) in two or three divided doses. To assess the effectiveness of the modified bowel preparation regimen, we evaluated the rate of total colonobservation, the effectiveness of bowel cleansing, andinterobserver agreement in assessing UC disease activity. We used a four-point grading scale (poor, fair, good, and excellent) for evaluating the quality of bowel cleansing. Matts' endoscopic score was used to evaluate disease activity. The rate of total colon observation was 85%, and 15 patients (75%) excreted the CCE-2 within 8 h. The proportion of excellent plus good cleansing was approximately 60%. There was a substantial interobserver agreement (κ = 0.777) in assessment of overall cleansing, which was still substantial at the fair cleansing level (κ = 0.700). Using CCE-2, the modified bowel preparation regimen, with reduced volume has the potential to succeed in the evaluation of mucosal severity in UC.
    Digestive Endoscopy 03/2014; · 1.61 Impact Factor
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    ABSTRACT: Crohn's disease (CD) is a lifelong chronic inflammatory bowel disease associated with diarrhea, abdominal pain, bloody stool and often perianal fistulae. Inflammation in CD involves the entire gastrointestinal tract, especially including the small and large bowels, causing irreversible bowel damage. Frequent imaging examinations are necessary to monitor disease activity and to evaluate response to therapeutic interventions, and, furthermore, to predict recurrence in order to provide appropriate treatment. The suitable imaging modality should be reproducible, well tolerated, safe and free of ionizing radiation. In recent years, imaging used in CD has dramatically changed. Cross-sectional imaging techniques such as computed tomography and magnetic resonance imaging (MRI) are used to investigate not only extraluminal abnormalities, but also intraluminal changes. Recently, new techniques such as MR enteroclysis, enterography, colonography and enterocolonography have been developed. These recent advances enable the use of MRI to assess bowel disorders with high sensitivity, specificity and accuracy. MRI can evaluate simultaneously the bowel surface, bowel wall, abdominal abscesses and perianal lesions, such as perianal fistulae and perianal abscesses, without the problem of overlapping bowel loops. Therefore, MRI has the potential for evaluation of the overall disease activity of CD without radiation exposure. We believe that MRI is a suitable first choice imaging modality in the assessment of CD. © 2014 S. Karger AG, Basel.
    Digestion 01/2014; 89(1):24-30. · 1.94 Impact Factor
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    ABSTRACT: We evaluated the clinical efficacy of adalimumab (ADA) for Crohn's disease (CD) and analyzed predictive factors for clinical remission and long-term prognosis.
    Digestion 01/2014; 90(2):130-6. · 1.94 Impact Factor
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    ABSTRACT: Background & Aims: Magnetic resonance (MR) enterography is a recommended imaging technique for detecting intestinal involvement in Crohn's disease (CD). However, the diagnostic accuracy of MR enterograpy has not been compared directly what that of enteroscopy of the jejunum and proximal ileum. We evaluated the usefulness of MR enterocolonography (MREC) by comparing its findings with those from balloon-assisted enteroscopy. Methods In a prospective study, MREC and enteroscopy were performed within 3 days of each other on 100 patients. Ulcerative lesions and all mucosal lesions were evaluated. Physicians and radiologists were blinded to results from other studies. Findings from MREC were directly compared with those from enteroscopy; the sensitivity and specificity with which MREC detected CD lesions were assessed. Results MREC detected ulcerative lesions and all mucosal lesions in the small intestine with 82.4% sensitivity (95% confidence interval [CI], 75.4%–87.7%) and 67.5% sensitivity (95% CI, 63.1%–70.0%), respectively; specificity values were 87.6% (95% CI, 83.7%–90.6%) and 94.8% (95% CI, 90.1%–97.5%), respectively. MREC detected major stenosis with 58.8% sensitivity (95% CI, 37.6%–77.2%) and 90.0% specificity (95% CI, 88.4%–91.5%) and all stenoses with 40.8% sensitivity (95% CI, 30.8%–49.4%) and 93.7% specificity (95% CI, 91.1–95.9%). Conclusions MREC is useful for detecting active lesions in the small intestine. However, MR imaging is less sensitive for detecting intestinal damage, such as stenoses. Enteroscopy is preferred for identifying intestinal damage. Suitable imaging approaches should be selected to assess CD lesions in deep small intestine.
    Gastroenterology 01/2014; · 12.82 Impact Factor
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    ABSTRACT: We investigated the safety, clinical efficacy, and significance of tacrolimus trough levels in 20 outpatients with active ulcerative colitis. Adverse effects were observed in 16 (80%) patients, and most events were reversible and showed improvement or complete recovery. Three patients required hospitalization because of disease aggravation. The rate of efficacious tacrolimus trough levels was 60% within 1 week and 95% within 2 weeks. At 12 weeks, the clinical remission rate was 25% and the improvement rate was 55%. The clinical remission rate was significantly higher in patients with the relapse-remission type than in those with the chronic inflammation type. These results indicate that the use of tacrolimus in outpatients with ulcerative colitis is safe and that efficacious trough levels can be rapidly achieved in these patients.
    Nippon Shokakibyo Gakkai zasshi The Japanese journal of gastro-enterology 01/2014; 111(2):276-87.
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    ABSTRACT: Background. Crohn's disease (CD) may involve any part of the gastrointestinal tract. We assessed the prevalence and features of upper gastrointestinal (UGI) lesions in CD. Methods. This was a retrospective study that included 138 CD patients that underwent esophagogastroduodenoscopy (EGD). The rate of Crohn's specific endoscopic lesions in the esophagus, stomach, and duodenum was assessed, and immunohistochemical analysis was performed. Changes in the UGI lesions were assessed in those who had two or more EGD. Results. Of 138 patients, 51.3% had Crohn's specific UGI lesions. The rates of Crohn's specific lesion in the esophagus, upper-to-middle stomach, lower stomach, duodenal bulb, and 2nd portion of the duodenum were 6.5%, 47.8%, 24.6%, 31.9%, and 18.1%, respectively. Granulomas were detected in 6.1%, 25.0%, and 11.4% in the upper-to-middle stomach, lower stomach, and duodenal bulb, respectively, but none in the esophagus and 2nd portion of the duodenum. Thirty-seven were analyzed for Helicobacter pylori and 4 were positive (10.8%). Improvements of UGI lesions were seen in 14 out of 49 (28.5%) and were unchanged in 59.2% and worsened in 12.2%. Conclusions. The prevalence of Crohn's specific UGI lesions was common in our case series, and immunohistochemical studies suggested that the majority was unrelated to Helicobacter pylori infection. Worsening of UGI lesions over the course was rare.
    BioMed research international. 01/2014; 2014:610767.
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    Makoto Naganuma, Naoki Hosoe, Haruhiko Ogata
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    ABSTRACT: Conventional ileocolonoscopy and barium small bowel follow-through are useful techniques for assessing the extension and severity of disease in patients with inflammatory bowel disease (IBD). More recently, novel techniques to enable IBD diagnosis have been developed, such as capsule endoscopy (CE), balloon enteroscopy (BE), computed tomography enterography (CTE) and magnetic resonance enterography (MRE). The advantages of CE and BE are that they enable mucosal assessment directly whereas the usefulness of CTE/MRE is in its ability to enable detection of transmural inflammation, stenosis, and extraintestinal lesions including abscesses and fistulas. In ulcerative colitis (UC), colitis-associated dysplasia/cancer is one of the criticalcomplications in patients with chronic disease. Detection of colitis-associated cancer is difficult in cases with inflammation. Magnification colonoscopy has been used to detect dysplasia in patients with chronic UC. Furthermore, colon CE and endocytoscopy have also developed and these might be used for selected patients in the near future.
    Digestive Endoscopy 08/2013; · 1.61 Impact Factor
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    ABSTRACT: BACKGROUND: Oral administration of tacrolimus is an effective remission induction therapy for steroid-refractory/dependent ulcerative colitis (UC). AIM: This study aimed to evaluate the short- as well as medium- and long-term effectiveness of tacrolimus therapy. METHODS: The medical records of 51 patients treated with tacrolimus for UC at our hospital between July 2009 and December 2011 were reviewed retrospectively. Clinical remission and improvement were defined as a Lichtiger score of 4 or less and as a Lichtiger score of ≤10 and a reduction in the score of ≥3 compared with the baseline score, respectively. Endoscopic findings were evaluated based on the endoscopic activity index and Mayo endoscopic score. RESULTS: The clinical effectiveness combining clinical remission and improvement was observed in 62.7% of the patients at 3months. Thirty-six patients underwent colonoscopy at 3months, and 12 (33.3%) and 10 patients (27.8%) showed Mayo endoscopic scores of 0 and 1, respectively. On Kaplan-Meier analysis, the overall percentage of event-free survivors, who did not require colectomy nor switching to other induction therapy such as infliximab, was 73.0% at 6months, 49.9% at 1year, and 37.8% at 2years. Patients with a Mayo endoscopic score of 0-1 at 3months showed significantly better medium- and long-term prognosis than those with a score of 2-3 (p<0.01). All adverse events, including infections in 2 patients, were reversible. CONCLUSIONS: Tacrolimus therapy was effective for inducing clinical and endoscopic remission of steroid-refractory/dependent UC. Endoscopic improvement was associated with favorable medium- and long-term prognosis.
    Journal of Crohn s and Colitis 05/2013; · 3.39 Impact Factor
  • Makoto Naganuma, Atsushi Sakuraba, Toshifumi Hibi
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    ABSTRACT: The clinical management of ulcerative colitis (UC) involves first treating the acute symptoms to induce remission, and then successfully maintaining it. Oral 5-aminosalicylic acids are safe and useful for maintaining remission in patients with UC. In terms of adherence, a once-daily form of 5-aminosalicylic acid is superior in maintaining remission as compared with split dosing. Patients at high risk of relapse may be candidates for treatment with thiopurines and/or biologics in the early stages of UC. Calcineurin inhibitors, such as cyclosporine and tacrolimus, are effective for severe, steroid-refractory UC patients. It is suggested that these patients use thiopurines as their maintenance therapy once they achieve remission with calcineurin inhibitors. Recent studies have confirmed that biologics are effective for inducing clinical and endoscopic remission of UC, and thus they may improve long-term prognosis of UC.
    Expert review of gastroenterology & hepatology 05/2013; 7(4):341-51.
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    ABSTRACT: BACKGROUND AND AIM: Colon capsule endoscopy has already been used for colon visualization and detection of polyps but its applicability to inflammatory bowel disease is still unconfirmed. To assess the feasibility of evaluating the severity of mucosal inflammation in patients with ulcerative colitis (UC) using a second generation colon capsule endoscope (CCE-2). METHODS: Forty patients with histological confirmed diagnosis of UC were enrolled. Low volume (2L) polyethylene glycol solution (PEG) with prokinetics (mosapride citrate and metoclopramide) regimen were used for the bowel preparation. In Phase 1, consisting of 10 patients, to confirm appropriate CCE-2 bowel preparation for UC. In Phase 2, consisting of 30 patients, CCE-2 was performed with a fixed bowel preparation regimen. CCE-2 findings were recorded for 8 hours starting from capsule ingestion and conventional colonoscopy was subsequently performed on the same day. CCE-2 procedure completion rate and the colon cleansing level with a 4-point grading scale (poor, fair, good, and excellent) were evaluated in Phase 2. Correlations between Matts endoscopic scores as judged by CCE-2 and conventional colonoscopy were calculated. RESULTS: CCE-2 procedure was completed within 8 hours in 69% of the patients. The proportion of patients with good or excellent cleansing level was below 50%. However, Matts endoscopic scores determined by CCE-2 showed a strong correlation with scores obtained by conventional colonoscopy (average ρ = 0.797). CONCLUSIONS: Though modifications in bowel preparation are needed, CCE-2 might be feasible for assessing the severity of mucosal inflammation in patients with UC.
    Journal of Gastroenterology and Hepatology 03/2013; · 3.33 Impact Factor

Publication Stats

838 Citations
431.32 Total Impact Points

Institutions

  • 2006–2014
    • University of Virginia
      • Division of Maternal Fetal Medicine
      Charlottesville, Virginia, United States
  • 2000–2014
    • Keio University
      • • School of Medicine
      • • Department of Internal Medicine
      Edo, Tōkyō, Japan
  • 2010–2012
    • Tokyo Medical and Dental University
      • • Department of Medicine
      • • Department of Gastroenterology and Hepatology
      Edo, Tōkyō, Japan
  • 2003
    • University of Texas Medical Branch at Galveston
      • Department of Microbiology and Immunology
      Galveston, TX, United States