A randomised, double-blind, placebo-controlled clinical study: the effects of a synbiotic, Lepicol, in adults with chronic, functional constipation

Abstract

The study objective was to evaluate the safety and effects of Lepicol® (pysllium 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 = 35) or placebo (n = 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.

Keywords:

• Constipation
• Lepicol
• symbiotic
• fibre
• probiotic
• clinical trial

Acknowledgements

We would like to thank research nurse, Mary Tuohy, who was involved in the recruitment of the subjects and conducted the clinical visits, and Emily Goodbody, clinical research assistant and nutritionist, who assisted with this clinical study.

Disclosure statement

Fergus Shanahan, Sally Cudmore and Andrea Doolan are co-founders and shareholders of Atlantia Food Clinical Trials Ltd. Seán Lacey is founder and Director of Lacey Maths and Stats Consultancy. Fergus Shanahan has received research funding from the following companies; GSK, Sigmoid Pharma, Trino Therapeutics, Alimentary Health and the Kerry Group.

Funding

This study was funded in full by Probiotics International Ltd., [n/a] which also provided the intervention and placebo products for this clinical study. This sponsor company was not involved in the conduct of the research, data analysis or manuscript preparation.