July 2019
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148 Reads
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57 Citations
Journal of Digestive Diseases
Aim: To investigate the clinical efficacy of a multi-strain probiotic product on bowel habits and microbial profile in subjects with functional constipation. Methods: This study (clinicaltrials.gov NCT02418507) was randomized, double-blind, placebo-controlled and parallel-arm. Ninety-four otherwise healthy adults with symptoms of functional constipation, aged 18 to 65 years, were randomized as part of the intention to treat population. Participants received placebo or the probiotic product (1.5x1010 CFU/day), consisting of L. acidophilus DDS-1, B. animalis subsp. lactis UABla-12, B. longum UABl-14 and B. bifidum UABb-10 over four weeks. Outcomes included the patient assessment of constipation-symptom (PAC-SYM) questionnaire, stool frequency and consistency, microbial profile and strain recovery. Results: There were no significant between group differences in the PAC-SYM score (P>0.05), despite significant within group differences (P<0.001) over the study. Subjects in the probiotic group demonstrated a faster normalization of stool frequency and consistency, with most subjects achieving a normalized profile after one week. Probiotic group fecal samples exhibited higher relative abundance of Ruminococcaceae (P=0.0047), including the Ruminococcus genus, and lower relative abundance of Erysipelotrichaceae (P=0.0172) at endpoint as compared to baseline. Placebo group samples showed similar abundance profiles over the study, with the exception of Clostridiaceae, which was lower at the study endpoint (P=0.0033). Among treated subjects, all four probiotic strains were significantly more abundant after intervention. Conclusions: No significant differences were observed in symptomology, with both groups showing a greater than 20% improvement. However, the probiotic helped modulate bowel function earlier than placebo, with a corresponding shift to a more fibrolytic microbiota. This article is protected by copyright. All rights reserved.