INTERNATIONAL JOURNAL OF FOOD SCIENCES AND NUTRITION, 2016 http://dx.doi.org/10.1080/09637486.2016.1244661
RESEARCH ARTICLE
A randomised, double-blind, placebo-controlled clinical study: the effects of a synbiotic, Lepicol, in adults with chronic, functional constipation , Andrea Doolan a , Se an Lacey c and Fergus Shanahan a,b,d a Atlantia Food Clinical Trials, Cork, Ireland; b APC Microbiome Institute, University College Cork, Cork, Ireland; c Department of Mathematics, Cork Institute of Technology, Cork, Ireland; d Cork University Hospital, School of Medicine, University College Cork, Cork, Ireland Sally Cudmore a,b
ABSTRACT The study objective was to evaluate the safety and effects of Lepicol V R (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 ¼ 35) or placebo ( n ¼ 34) daily. Both groups had improved frequency of bowel move- ments, 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 aver- age 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 pla- cebo. Symptoms of constipation improved to a greater degree and there was a significant reduc- tion in laxative use in the Lepicol group.
ARTICLE HISTORY Received 28 June 2016 Revised 27 September 2016 Accepted 1 October 2016 Published online 25 October 2016 KEYWORDS Constipation; Lepicol; symbiotic; fibre; probiotic; clinical trial
Background Chronic constipation is physically and psychologically difficult for sufferers as it can interfere significantly with daily life and overall well-being. It is common in the general population with a reported incidence which varies from 2 to 27 % (Talley et al. 1993; Hunt et al. 2007; Pinto Sanchez & Bercik 2011; Ford et al. 2014); women, overweight and elderly individuals are more commonly affected (Talley et al. 1996; Choung et al. 2007; Phatak & Pashankar 2014). Health care costs related to constipation are also substantial, with an estimated $700 million spent annually on laxatives alone in the USA (Crowell et al. 2009) and £67 mil- lion spent in the UK (Gudsoorkar & Quigley 2013). In the absence of symptoms such as bleeding, anaemia, fever, and weight loss, chronic constipation is usually a functional disorder, without specific cause. Most people report having at least three bowel move- ments per week, so that two or fewer is often consid- ered abnormal in western cultures. However, frequency of bowel movements is not the sole indica- tor of constipation. Hard or lumpy stools, effort required in expelling them, sense of incomplete evacu- ation, and accompanying abdominal discomfort, bloat- ing and distension may be important accompaniments
to infrequent bowel movements. About one third of constipated patients seek medical attention, whereas the majority use over-the-counter medications or sup- plements, such as laxatives, probiotics, fibre or homeo- pathic remedies (Heaton et al. 1992; Frank et al. 1999; Pare et al. 2001; Irvine et al. 2002; Quigley 2011; Quigley 2012). Food-based products purported to have a beneficial effect on gastrointestinal health, have become increasingly popular. In light of global demo- graphic trends, with an ageing population and rising obesity levels, increases in the prevalence of constipa- tion may be anticipated. Synbiotics are defined as “ mixtures of probiotics and prebiotics that beneficially affect the host by improving the survival and implantation of live micro- bial dietary supplements in the gastrointestinal tract, by selectively stimulating the growth and/or by acti- vating the metabolism of one or a limited number of health-promoting bacteria, thus improving host welfare ” (Gibson & Roberfroid 1995). The synbiotic, Lepicol V R , is a combination of fibre (psyllium), prebiot- ics (inulin) and five probiotic strains that were selected to provide synergistic effects in alleviating constipation. Psyllium husk is a soluble, gel-forming fibre with high water holding capacity that can
CONTACT Sally Cudmore, PhD s.cudmore@ucc.ie APC Microbiome Institute, Biosciences Building, University College Cork, Ireland 2016 Informa UK Limited, trading as Taylor & Francis Group
Powered by FlippingBook