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considered eligible for the study and were then asked to keep pre-study symptom diaries for 2 weeks, which recorded all bowel movements and any medication/ laxative use, and to refrain from consuming any pro- biotic-containing product or dietary fibre supplements. Subjects returned for a baseline visit (visit 2) within 3 weeks and the pre-study diary was examined to establish eligibility for study entry. If eligible (based on Rome III criteria), subjects were randomised to receive either Lepicol or placebo (1:1), and received a 4-week supply of product in sachets with instructions for oral dosing. Subjects completed the Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation – Quality of Life (PAC-QOL) questionnaires, and a survey on con- comitant medication/laxatives. They also completed daily a symptom diary for the duration of the study. The participants were permitted to take their usual laxative medication, as necessary, but additional pro- biotic products and/or dietary fibre supplements were not permitted. During the 4-week intervention period subjects were contacted twice by telephone to assess compliance with consumption of study product and completion of the symptom diaries. At the final visit (visit 3) after 28 days, any unused study product was returned with completed daily dia- ries, and the PAC-QOL and PAC-SYM questionnaires (Table 1) were undertaken. Volunteers were remuner- ated e 150 upon completion of the study. Trial subjects Subjects enrolled into the study were healthy males and females aged between 18 and 80 (Table 2) who met the Rome III diagnostic criteria for functional constipation within the previous 3 months, as follows: (1) subjects had fewer than three defecations per week and one or more of the following; (i) Straining during at least 25 % of defecations, (ii) lumpy or hard stools in at least 25 % of defecations, (iii) sensation of incomplete evacuation for at least 25 % of defecations, (iv) sensation of anorec- tal obstruction/blockage for at least 25 % of defecations, (v) manual manoeuvre to facilitate at least 25 % of defe- cations (e.g. digital evacuation, support of the pelvic floor); (2) loose stools were rarely present without the use of laxatives; and (3) there were insufficient criteria for irritable bowel syndrome (Table 3). Exclusion criteria included the use of a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit (visit 2); women who were pregnant, lactating or wishing to become pregnant during the study; hypersensitivity to any of the compo- nents of the test product; significant acute or chronic,
facilitate stool softening and bulking in patients with chronic constipation (McRorie et al. 1998) and a sys- tematic review of its use in idiopathic constipation indicated an improvement in symptoms such as straining, pain, stool consistency and an increase in mean stool number per week (Suares & Ford 2011). Consumption of specific strains of lactobacilli or bifi- dobacteria, which are normal residents of the human intestine, has been linked with improvements in bowel movements, improved function of intestinal immune barrier and prevention of colon cancer (Petschow et al. 2013). The ingestion of prebiotics, such as chic- ory root inulin, can stimulate the growth of beneficial bifidobacteria and lactobacilli in the colon (Marteau et al. 2011). This clinical study was designed to assess the efficacy and safety of a synbiotic, Lepicol, versus placebo in adults with chronic constipation after 4 weeks consumption. Methods Trial design, ethical approval and registration This was a 4-week, randomised, double-blind, pla- cebo-controlled, parallel group trial conducted at a single site (Atlantia Food Clinical Trials clinic) in Cork, Ireland between February 10th (first subject, first visit) and July 17th (last subject, last visit) 2014. This study was conducted according to the guidelines laid down in the Declaration of Helsinki, and in accordance with the principles of Good Clinical Practise (GCP). All procedures involving human sub- jects were approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC). Written informed consent was obtained from all sub- jects. The trial was registered on clinicaltrials.gov under registration identification number NCT02073006, http://clinicaltrials.gov/ct2/home. All the participants, research nurses, medical personnel, personnel entering data and the project manager were blinded to the interventions. An initial screening of subjects who responded to advertisements in the local press was conducted by telephone and suitable volunteers (based on age and reported number of bowel movements per week) were invited to attend a screening visit (visit 1) at which the study and inclusion/exclusion criteria were explained, and informed consent was obtained from each study participant. Medical history, demographic data and concomitant medication were recorded and urinary pregnancy tests were performed for women of childbearing age. Subjects who met the Rome III diag- nostic criteria for functional constipation were
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