Jean-Paul Galmiche

University of Nantes, Naoned, Pays de la Loire, France

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Publications (76)582.04 Total impact

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    ABSTRACT: Objective: To assess the long-term effect on symptoms and quality of life of esomeprazole 20 mg once daily, a recommended dose for maintenance therapy of gastroesophageal reflux disease (GERD). Research design and methods: This is a post hoc analysis of 5 year data from patients in the LOTUS trial (ClinicalTrials.gov identifier: NCT00251927) who were randomized to esomeprazole 20 mg once daily. All participants had chronic, symptomatic GERD responsive to treatment. Gastrointestinal symptoms were assessed by physicians and by using patient-reported outcome instruments. Investigations included gastrointestinal endoscopy (with biopsy sampling), 24 hour esophageal pH monitoring and laboratory measurements. Results: In total, 157 of 256 patients randomized to esomeprazole 20 mg once daily remained on this dose until the end of follow-up or study discontinuation, whereas 99 patients had their dose increased because of inadequate symptom control (of these, 29 subsequently returned to the allocated dose). On logistic regression, a long objectively defined GERD history, smoking, female sex, absence of Helicobacter pylori infection and high supine baseline acid reflux into the esophagus were associated with an increased likelihood of requiring dose escalation to esomeprazole 40 mg daily (all p < 0.05). Symptoms were fairly stable and quality of life was normal throughout follow-up in patients remaining on esomeprazole 20 mg once daily, with no more than mild symptom severity, and mean (standard deviation) percentage time with intraesophageal pH <4 was reduced from 10.7 (10.7) pre-randomization to 6.3 (10.2) at 6 months and 4.9 (7.3) at 5 years. The number of serious adverse events was low (0.079 per patient per year). Limitations: Post hoc analysis with no control group. Conclusions: Esomeprazole at a maintenance dose of 20 mg once daily offers effective long-term treatment for chronic GERD in patients initially responsive to the medication, with durable symptom control and sustained reductions in intraesophageal acid exposure.
    Current Medical Research and Opinion 10/2014; 31(1). DOI:10.1185/03007995.2014.980500 · 2.37 Impact Factor
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    ABSTRACT: Objective: Acute gastrointestinal graft-versus-host disease (GI-GVHD) is usually diagnosed using endoscopic examinations and biopsies for conventional histology. The aim of this pilot study was to determine whether mini-invasive techniques such as probe-based confocal laser endomicroscopy (pCLE) combined with wireless capsule endoscopy (WCE) could detect early lesions of GI-GVHD prior to symptoms. Design: Fifteen patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) were prospectively examined with a small bowel WCE, duodenal and colorectal pCLE, and standard biopsies. Per study protocol, all these examinations were scheduled between day 21 and day 28 after allo-HSCT, independently of the presence or absence of digestive symptoms. Results: During follow up, eight patients developed acute GI-GVHD. Sensitivity of WCE, pCLE, and histology were 50, 87.5, and 50%, respectively. Specificity of WCE, pCLE, and histology were 80, 71.5, and 80%, respectively. We showed a positive correlation between the Glucksberg scoring system and WCE (rho = 0.543, p = 0.036) and pCLE (rho = 0.727, p = 0.002) but not with standard histology (rho = 0.481, p = 0.069). Conclusions: The results from this pilot study suggest that novel methods such as pCLE and WCE could be part of a mini-invasive algorithm for early detection of GI-GVHD.
    06/2014; 2(3):206-15. DOI:10.1177/2050640614529283
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    ABSTRACT: BACKGROUND:: Small bowel capsule endoscopy is the most sensitive technique for the detection of lesions in the small intestine. The aims of the study were to assess the prevalence and clinical significance of jejunal lesions detected by small bowel capsule endoscopy in patients with an established Crohn's disease. RESULTS:: One hundred and eight patients, including 32 patients with ileal disease, 25 patients with colonic disease, and 51 patients with ileocolonic disease, underwent small bowel capsule endoscopy, and findings were analyzed retrospectively. Jejunal lesions were detected in 56% of these patients, of whom 18 (17%) had lesions only in the jejunum. Jejunal lesions were less frequently detected (12% versus 38%, P = 0.001) when location of the disease was limited to the colon at ileocolonoscopy. Conversely, when Crohn's disease affected the ileum, jejunal lesions were more frequently detected (40% versus 17%, P = 0.007). During a median follow-up time of 24.0 months (interquartile, 8.0-46.2), 50 clinical relapses occurred. The presence of jejunal lesions was the only independent factor associated with an increased risk of relapse (P = 0.02). In nonsmokers and in patients treated by immunosuppressors, the presence of jejunal lesions tended to increase the risk of relapse (P = 0.06 and 0.05, respectively). CONCLUSIONS:: Jejunal lesions are detected in more than half of the patients with Crohn's disease. The prevalence of jejunal lesions is higher when the terminal ileum is involved and associated with an increased risk of further clinical relapse. It may be regarded as a factor of severity.
    Inflammatory Bowel Diseases 04/2013; 19(7). DOI:10.1097/MIB.0b013e31828133c1 · 5.48 Impact Factor
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    ABSTRACT: BACKGROUND & AIMS: Saccharomyces boulardii is a probiotic yeast that has been shown to have beneficial effects on the intestinal epithelial barrier and digestive immune system. There is preliminary evidence that S boulardii could be used to treat patients with Crohn's disease (CD). We performed a randomized, placebo-controlled trial to evaluate the effects of S boulardii in patients with CD who underwent remission during therapy with steroids or aminosalicylates. METHODS: We performed a prospective study of 165 patients who achieved remission following treatment with steroids or salicylates; they were randomly assigned to groups given S boulardii (1 g/day) or placebo for 52 weeks. The primary endpoint was the percentage of patients in remission at week 52. Time to relapse, Crohn's disease activity index (CDAI) scores, and changes in parameters of inflammation were secondary endpoints. RESULTS: CD relapsed in 80 patients: 38 in the S boulardii group (47.5%) and 42 in the placebo group (53.2%; a nonsignificant difference). The median time to relapse did not differ significantly between patients given S boulardii (40.7 weeks) vs placebo (39.0 weeks). There were no significant differences between groups in mean CDAI scores or erythrocyte sedimentation rates, or in median levels of C-reactive protein. In a post-hoc analysis, nonsmokers given S boulardii were less likely to experience a relapse of CD than nonsmokers given placebo, but this finding requires confirmation. CONCLUSION: Although the probiotic yeast, Sboulardii, is safe and well tolerated, it does not appear to have any beneficial effects for patients with CD in remission following steroid or salicylate therapies.
    Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association 03/2013; 11(8). DOI:10.1016/j.cgh.2013.02.021 · 6.53 Impact Factor
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    ABSTRACT: OBJECTIVES: Patients with heartburn and normal upper gastrointestinal endoscopy, normal oesophageal acid exposure, no symptom-reflux association and who fail to respond to a proton-pump inhibitor are classified as having functional heartburn (FH). This study aimed (i) to characterize the symptoms and functional abnormalities of patients with FH and (ii) to describe their clinical outcome. MATERIALS AND METHODS: Among all patients referred for 24 h multichannel intraluminal impedance-pH (MII-pH), patients with FH were identified. The clinical characteristics and high-resolution oesophageal pressure topography recordings of FH patients were analyzed at the time of the 24-h MII-pH test. A symptom-related and health-related quality-of-life questionnaire was then sent to FH patients to assess the long-term outcome. RESULTS: Forty patients fulfilled the criteria for FH, representing 8.5% of the referred population. Twenty-two months after initial testing, 66% of patients still suffered from heartburn. The rate of mixed reflux (liquid/gas) was higher in patients with persisting heartburn at the final evaluation (63 vs. 50%, P=0.04). Sixty-six per cent of patients had one or more manometric abnormalities. Acid clearance time in MII-pH was significantly higher in patients with weak peristalsis than patients with normal peristalsis (60±45 vs. 31±19 s, P=0.03). A high rate of mixed reflux and/or a manometric abnormality were associated with a higher risk of persistent heartburn. CONCLUSION: FH is a chronic disorder with persisting symptoms in two-thirds of patients. An increased rate of mixed reflux and/or the presence of manometric abnormalities are associated with a higher risk of persisting symptoms and may help to identify the population with unmet therapeutic needs.
    European journal of gastroenterology & hepatology 11/2012; 25(3). DOI:10.1097/MEG.0b013e32835b108f · 2.15 Impact Factor
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    ABSTRACT: Esophageal adenocarcinoma (EA) is increasingly common among patients with Barrett's esophagus (BE). We aimed to provide consensus recommendations based on the medical literature that clinicians could use to manage patients with BE and low-grade dysplasia, high-grade dysplasia (HGD), or early-stage EA. We performed an international, multidisciplinary, systematic, evidence-based review of different management strategies for patients with BE and dysplasia or early-stage EA. We used a Delphi process to develop consensus statements. The results of literature searches were screened using a unique, interactive, Web-based data-sifting platform; we used 11,904 papers to inform the choice of statements selected. An a priori threshold of 80% agreement was used to establish consensus for each statement. Eighty-one of the 91 statements achieved consensus despite generally low quality of evidence, including 8 clinical statements: (1) specimens from endoscopic resection are better than biopsies for staging lesions, (2) it is important to carefully map the size of the dysplastic areas, (3) patients that receive ablative or surgical therapy require endoscopic follow-up, (4) high-resolution endoscopy is necessary for accurate diagnosis, (5) endoscopic therapy for HGD is preferred to surveillance, (6) endoscopic therapy for HGD is preferred to surgery, (7) the combination of endoscopic resection and radiofrequency ablation is the most effective therapy, and (8) after endoscopic removal of lesions from patients with HGD, all areas of BE should be ablated. We developed a data-sifting platform and used the Delphi process to create evidence-based consensus statements for the management of patients with BE and early-stage EA. This approach identified important clinical features of the diseases and areas for future studies.
    Gastroenterology 04/2012; 143(2):336-46. DOI:10.1053/j.gastro.2012.04.032 · 13.93 Impact Factor
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    ABSTRACT: Approximately 30% of patients with gastro-oesophageal reflux disease (GORD) do not achieve adequate symptom control with proton pump inhibitors (PPIs). The aim of this study was to determine whether any symptom profile or reflux pattern was associated with refractoriness to PPI therapy. Patients with typical GORD symptoms (heartburn and/or regurgitation) were included and had 24 h pH-impedance monitoring off therapy. Patients were considered to be responders if they had fewer than 2 days of mild symptoms per week while receiving a standard or double dose of PPI treatment for at least 4 weeks. Both clinical and reflux parameters were taken into account for multivariate analysis (logistic regression). One hundred patients were included (median age 50 years, 42 male), 43 responders and 57 non-responders. Overall, multivariate analysis showed that the factors associated with the absence of response were absence of oesophagitis (p=0.050), body mass index (BMI) ≤25 kg/m(2) (p=0.002) and functional dyspepsia (FD) (p=0.001). In patients who reported symptoms during the recording (n=85), the factors associated with PPI failure were BMI ≤25 kg/m(2) (p=0.004), FD (p=0.009) and irritable bowel syndrome (p=0.045). In patients with documented GORD (n=67), the factors associated with PPI failure were absence of oesophagitis (p=0.040), FD (p=0.003), irritable bowel syndrome (p=0.012) and BMI ≤25 kg/m(2) (p=0.029). No reflux pattern demonstrated by 24 h pH-impedance monitoring is associated with response to PPIs in patients with GORD symptoms. In contrast, absence of oesophagitis, presence of functional digestive disorders and BMI ≤25 kg/m(2) are strongly associated with PPI failure.
    Gut 04/2012; 61(4):501-6. DOI:10.1136/gutjnl-2011-300798 · 13.32 Impact Factor
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    ABSTRACT: Probe-based confocal laser endomicroscopy (pCLE) allows real-time detection of neoplastic Barrett's esophagus (BE) tissue. However, the accuracy of pCLE in real time has not yet been extensively evaluated. To compare the sensitivity and specificity of pCLE in addition to high-definition white-light endoscopy (HD-WLE) with HD-WLE alone for the detection of high-grade dysplasia (HGD) and early carcinoma (EC) in BE. International, prospective, multicenter, randomized, controlled trial. Five tertiary referral centers. A total of 101 consecutive BE patients presenting for surveillance or endoscopic treatment of HGD/EC. All patients were examined by HD-WLE, narrow-band imaging (NBI), and pCLE, and the findings were recorded before biopsy samples were obtained. The order of HD-WLE and NBI was randomized and performed by 2 independent, blinded endoscopists. All suspicious lesions on HD-WLE or NBI and 4-quadrant random locations were documented. These locations were examined by pCLE, and a presumptive diagnosis of benign or neoplastic (HGD/EC) tissue was made in real time. Finally, biopsies were taken from all locations and were reviewed by a central pathologist, blinded to endoscopic and pCLE data. Diagnostic characteristics of pCLE. The sensitivity and specificity for HD-WLE were 34.2% and 92.7%, respectively, compared with 68.3% and 87.8%, respectively, for HD-WLE or pCLE (P = .002 and P < .001, respectively). The sensitivity and specificity for HD-WLE or NBI were 45.0% and 88.2%, respectively, compared with 75.8% and 84.2%, respectively, for HD-WLE, NBI, or pCLE (P = .01 and P = .02, respectively). Use of pCLE in conjunction with HD-WLE and NBI enabled the identification of 2 and 1 additional HGD/EC patients compared with HD-WLE and HD-WLE or NBI, respectively, resulting in detection of all HGD/EC patients, although not statistically significant. Academic centers with enriched population. pCLE combined with HD-WLE significantly improved the ability to detect neoplasia in BE patients compared with HD-WLE. This may allow better informed decisions to be made for the management and subsequent treatment of BE patients. (Clinical trial registration number: NCT00795184.).
    Gastrointestinal endoscopy 07/2011; 74(3):465-72. DOI:10.1016/j.gie.2011.04.004 · 4.90 Impact Factor
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    ABSTRACT: Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system. To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy. Prospective, multicenter trial including 8 European sites. This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed. CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day. CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed. Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients. Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients. In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.
    Gastrointestinal endoscopy 05/2011; 74(3):581-589.e1. DOI:10.1016/j.gie.2011.03.1125 · 4.90 Impact Factor
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    ABSTRACT: Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery. To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD. The LOTUS trial, a 5-year exploratory randomized, open, parallel-group trial conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients with well-established chronic GERD who initially responded to acid suppression. A total of 372 patients (esomeprazole, n = 192; LARS, n = 180) completed 5-year follow-up. Interventions Two hundred sixty-six patients were randomly assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actually underwent the operation. Time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates and analyzed using the Kaplan-Meier method. Estimated remission rates at 5 years were 92% (95% confidence interval [CI], 89%-96%) in the esomeprazole group and 85% (95% CI, 81%-90%) in the LARS group (log-rank P = .048). The difference between groups was no longer statistically significant following best-case scenario modeling of the effects of study dropout. The prevalence and severity of symptoms at 5 years in the esomeprazole and LARS groups, respectively, were 16% and 8% for heartburn (P = .14), 13% and 2% for acid regurgitation (P < .001), 5% and 11% for dysphagia (P < .001), 28% and 40% for bloating (P < .001), and 40% and 57% for flatulence (P < .001). Mortality during the study was low (4 deaths in the esomeprazole group and 1 death in the LARS group) and not attributed to treatment, and the percentages of patients reporting serious adverse events were similar in the esomeprazole group (24.1%) and in the LARS group (28.6%). This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years. clinicaltrials.gov Identifier: NCT00251927.
    JAMA The Journal of the American Medical Association 05/2011; 305(19):1969-77. DOI:10.1001/jama.2011.626 · 30.39 Impact Factor
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    ABSTRACT: Early detection is an essential prognostic factor in colorectal cancer (CRC) recurrence. Our aim was to evaluate diagnostic performances of (18)F-fluorodeoxyglucose-positron emission tomography ((18)F-FDG-PET)/computed tomography (CT) as compared with CT in the detection of CRC recurrence. Data of patients with suspected CRC recurrence and in whom both FDG-PET/CT and CT were performed were analyzed. All detected lesions were characterized according to their number, size, and localization. Positive histological or radiological follow-up was considered as the 'gold standard'. Diagnostic performances of FDG-PET/CT and CT were calculated by lesion, globally and with respect to the site of recurrence. One hundred and seventy-six true-positive lesions were identified in 71 patients. CT scan was positive in 58 (82%) patients and FDG-PET/CT in 70 (98%) patients. In per lesion analysis, the global accuracy of FDG-PET/CT in detection of lesions was of 88% (sensitivity = 95%, specificity = 54%), which was higher than that of CT (53%, sensitivity = 55%, specificity = 43%), particularly in case of lymph nodes metastases (100 vs. 35%) and locoregional lesions (100 vs. 39%) (P<0.0001). FDG-PET/CT modified the clinical management in 31 patients. FDG-PET/CT is more sensitive than CT for diagnosis of CRC recurrence and can modify the management in 40% of patients.
    European journal of gastroenterology & hepatology 03/2011; 23(3):275-81. DOI:10.1097/MEG.0b013e328343eaa0 · 2.15 Impact Factor
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    ABSTRACT: Because the reflux of the acidic gastric content into the esophagus plays a major role in the pathogenesis of symptoms of GERD and lesions of erosive esophagitis, acid suppression with a proton pump inhibitor (PPI) is currently the mainstay of anti-reflux therapy. There is a strong correlation between the degree of acid suppression provided by a given drug and its efficacy. The superiority of PPIs over other drugs (antacids, prokinetics and H(2)-receptor antagonists) has now been established beyond doubt, both for short- and long-term treatment. However, there are still some unmet therapeutic needs in GERD; hence, patients with non-erosive reflux disease (NERD) are less responsive to PPIs than those with erosive esophagitis. Moreover, the efficacy of PPIs in patients with atypical symptoms is frequently limited to the relief of associated heartburn or regurgitation. With respect to safety, although most studies on short- and long-term PPI use have provided reassuring data, recent reports have drawn attention to potential side effects or drug-drug interference. Better healing rates in the most severe forms of esophagitis, or a faster onset of symptom relief, may require optimization of acid suppressive therapy with regard to the daily course of acid secretion, especially during the night. Different pharmacological approaches can be considered, with the ultimate goals of achieving faster, stronger and more-sustained acid inhibition. How a better pharmacological profile may translate into clinical benefit should now be tested in appropriate, controlled studies.
    Best practice & research. Clinical gastroenterology 12/2010; 24(6):905-21. DOI:10.1016/j.bpg.2010.09.004 · 3.28 Impact Factor
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    ABSTRACT: The presence of Lewy bodies and Lewy neurites (LN) has been demonstrated in the enteric nervous system (ENS) of Parkinson's disease (PD) patients. The aims of the present research were to use routine colonoscopy biopsies (1) to analyze, in depth, enteric pathology throughout the colonic submucosal plexus (SMP), and (2) to correlate the pathological burden with neurological and gastrointestinal (GI) symptoms. A total of 10 control and 29 PD patients divided into 3 groups according to disease duration were included. PD and GI symptoms were assessed using the Unified Parkinson's Disease Rating Scale part III and the Rome III questionnaire, respectively. Four biopsies were taken from the ascending and descending colon during the course of a total colonoscopy. Immunohistochemical analysis was performed using antibodies against phosphorylated alpha-synuclein, neurofilaments NF 220 kDa (NF) and tyrosine hydroxylase (TH). The density of LN, labeled by anti-phosphorylated alpha-synuclein antibodies, was evaluated using a quantitative rating score. Lewy pathology was apparent in the colonic biopsies from 21 patients and in none of the controls. A decreased number of NF-immunoreactive neurons per ganglion was observed in the SMP of PD patients compared to controls. The amount of LN in the ENS was inversely correlated with neuronal count and positively correlated with levodopa-unresponsive features and constipation. Analysis of the ENS by routine colonoscopy biopsies is a useful tool for pre-mortem neuropathological diagnosis of PD, and also provides insight into the progression of motor and non-motor symptoms.
    PLoS ONE 09/2010; 5(9):e12728. DOI:10.1371/journal.pone.0012728 · 3.53 Impact Factor
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    British Journal of Clinical Pharmacology 08/2010; 70(2):280-3. DOI:10.1111/j.1365-2125.2010.03686.x · 3.69 Impact Factor
  • Gastroenterology 05/2010; 138(5). DOI:10.1016/S0016-5085(10)60340-X · 13.93 Impact Factor
  • Gastroenterology 05/2010; 138(5). DOI:10.1016/S0016-5085(10)62351-7 · 13.93 Impact Factor
  • Gastroenterology 05/2010; 138(5). DOI:10.1016/S0016-5085(10)63553-6 · 13.93 Impact Factor
  • Gastroenterology 05/2010; 138(5). DOI:10.1016/S0016-5085(10)60619-1 · 13.93 Impact Factor
  • Gastroenterology 05/2010; 138(5). DOI:10.1016/S0016-5085(10)60712-3 · 13.93 Impact Factor
  • Gastroenterology 05/2010; 138(5). DOI:10.1016/S0016-5085(10)62984-8 · 13.93 Impact Factor

Publication Stats

2k Citations
582.04 Total Impact Points

Institutions

  • 2008–2014
    • University of Nantes
      • • Faculté de Médecine
      • • Département de Mathématiques
      Naoned, Pays de la Loire, France
  • 2003–2011
    • Centre Hospitalier Universitaire de Nantes
      • Institut des maladies de l'appareil digestif
      Naoned, Pays de la Loire, France
  • 2004–2010
    • Unité Inserm U1077
      Caen, Lower Normandy, France
  • 2006
    • French Institute of Health and Medical Research
      Lutetia Parisorum, Île-de-France, France
  • 2002–2005
    • Le Centre de Recherche en Nutrition Humaine Rhône-Alpes
      Rhône-Alpes, France