INTERNATIONAL JOURNAL OF FOOD SCIENCES AND NUTRITION 11
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.
Constipation is often related to diet and physical activity, and while subjects were asked not to change their habitual diet or level of physical activity for the duration of this study, these were not analysed during this study, and should be taken into consideration in future studies. Another limitation of this study was the small numbers of participants – the study was powered to detect a change in bowel movements of 1.5 per week, but this endpoint was not met with the study numbers ( n ¼ 35 per group) and high placebo effect. We suggest a follow-up study powered to the high-pla- cebo effect seen (the data from this study suggests n ¼ 67 per group), and with a psyllium only arm as a control, which has previously shown to provide a simi- lar increase in BM per week. We also recommend that the stool is tested for the presence/absence of the pro- biotic strains before and after the study. Conclusions 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 dem- onstrate that a twice daily consumption of the synbi- otic, Lepicol, improved the quality of life of subjects with constipation. Lepicol did increase bowel move- ments per week significantly in the first 2 weeks in subjects with chronic, functional constipation but the significance was not maintained over placebo in weeks 3 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 laxa- tives 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. Acknowledgements We would like to thank research nurse, Mary Tuohy, who was involved in the recruitment of the subjects and con- ducted 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. Se an 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.
ORCID Sally Cudmore http://orcid.org/0000-0002-3131-7428 Fergus Shanahan http://orcid.org/0000-0003-0467-0936
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