title: 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.
authors: a Atlantia Food Clinical Trials, Cork , Ireland.|b APC Microbiome Institute, University College Cork , Cork , Ireland.
authors: Sally
authors: S
authors: Cudmore
authors: a Atlantia Food Clinical Trials, Cork , Ireland.
authors: Andrea
authors: A
authors: Doolan
authors: c Department of Mathematics , Cork Institute of Technology , Cork , Ireland.
authors: Seán
authors: S
authors: Lacey
authors: a Atlantia Food Clinical Trials, Cork , Ireland.|b APC Microbiome Institute, University College Cork , Cork , Ireland.|d Cork University Hospital, School of Medicine, University College Cork , Cork , Ireland.
authors: Fergus
authors: F
authors: Shanahan
mesh_terms: D000328:Adult; D002908:Chronic Disease; D003248:Constipation / Q000188:drug therapy*; D003672:Defecation / Q000502:physiology; D004043:Dietary Fiber / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007444:Inulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage*; D011788:Quality of Life; D058616:Synbiotics / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D004043:Dietary Fiber; D007444:Inulin
keywords: Constipation; Lepicol; clinical trial; fibre; probiotic; symbiotic