A randomised, double-blind, placebo-controlled clinical study: the effects of a synbiotic, Lepicol, in adults with chronic, functional constipation
Sally Cudmore, Andrea Doolan, Seán Lacey & Fergus Shanahan
subjects with functional constipation
International Journal of food sciences and nutrition
The study objective was to evaluate the safety and effects of Lepicol (psyllium fibre, inulin and 5 probiotic strains) in adults with chronic, functional constipation during a 4 week intervention. 69 subjects with functional constipation according to Rome III criteria were randomised to receive Lepicol (n ¼ 35) or placebo (n ¼ 34) daily. Both groups had improved frequency of bowel movements, with an increase of 1.082 bowel movements in the Lepicol group over placebo after one week, and 1.079 more than placebo after week 2, but with no significant difference at week 4.Both groups showed significant improvements in quality of life scores at 4 weeks, with the average score being 12.033% better in the Lepicol group, which also had 15.2% improvement in intensity of symptoms and 28.5% increase in satisfaction with quality of life compared to the placebo. Symptoms of constipation improved to a greater degree and there was a significant reduction in laxative use in the Lepicol group.
While this study did not reach its primary endpoint of increasing bowel movements per week (due to the low subject numbers and high placebo effect), it did demonstrate that a twice daily consumption of the synbiotic, Lepicol, improved the quality of life of subjects with constipation. Lepicol did increase bowel movements per week significantly in the first 2 weeks in subjects with chronic, functional constipation but the significance was not maintained over placebo in weeks3 and 4. Lepicol also improved the overall quality of life scores (PAC-QOL) and constipation symptoms(PAC-SYM) at 4 weeks, and reduced the use of laxatives during the study versus placebo. In addition, Lepicol was safe. Therefore, this food supplement, containing fibre, prebiotic and five probiotic strains, has the potential to offer relief from symptoms of functional constipation.
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