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.
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The systematic review included 17 randomised controlled trials comprising 1256 adult patients with functional constipation.
“17 studies, comprising 1256 participants, were included with perfect agreements between two researchers (kappa statistic=0.797).”
Cites
Probiotics, prebiotics, and the host microbiome: the science of translation
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Cao, H., Liu, X., An, Y., Zhou, G., Liu, Y., Xu, M., Dong, W., Wang, S., Yan, F., Jiang, K., et al. (2017) · Scientific Reports · doi:10.1038/s41598-017-10835-8 · Cited by 253 · see citing works
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“17–19 26 30 Overall, probiotics-containing products significantly reduced the PAC-SYM by 0.28 compared with placebo (WMD −0.28, 95% CI −0.45 to −0.11, p=0.001) with moderate heterogeneity (I²=55.7%), as shown in figure 2C.”
BackgroundInfluential
- Authors
- Cudmore, S., Doolan, A., Lacey, S., & Shanahan, F.
- Affiliations
- University College Cork (IE)
- Atlantia Food Clinical Trials (IE)
- Munster Technological University (IE)
- Corresponding author
- Cudmore, Sally
- Venue
- International Journal of Food Sciences and Nutrition
- Publisher
- Informa UK Limited
- Published
- 2016-10-24
- Volume
- 68
- Issue
- 3
- Pages
- 366-377
- ISSN
- 0963-7486 (ISSN-L)
- 1465-3478
- OpenAlex
- W2537384127
- Cited by
- 26
- References
- 1
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 3 · 2023: 2 · 2022: 3 · 2021: 3 · 2020: 2 · 2019: 1 · 2018: 5 · 2017: 2
- FWCI
- 2.91
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Food Sciences and Nutrition (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Alimentary Health
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Nursing › Nutrition and Dietetics › Microbial Metabolites in Food Biotechnology
- Keywords
- functional constipation, synbiotics, inulin, probiotics, stool frequency, quality of life, laxative use, Rome III criteria
- MeSH terms
- Adult, Chronic Disease, Constipation, Defecation, Dietary Fiber, Double-Blind Method, Female, Humans, Inulin, Male, Middle Aged, Quality of Life, Treatment Outcome, Probiotics, Synbiotics
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