Charlotte L Kvasnovsky1,2,3, Ingvar Bjarnason3, Ana Nora Donaldson4, Roy A Sherwood3, Savvas Papagrigoriadis5. 1. University of Maryland Medical Center, Baltimore, MD, USA. 2. King's College London, London, UK. 3. King's College Hospital, Denmark Hill, London, SE5 9RS, UK. 4. State University of New York, Stony Brook, NY, USA. 5. King's College Hospital, Denmark Hill, London, SE5 9RS, UK. spapagrigoriadis@nhs.net.
Abstract
BACKGROUND: Diverticular disease is a significant burden on healthcare systems that is managed, surgically or medically, mainly as an emergency or acute condition. There are no standardized treatment recommendations for symptomatic uncomplicated disease. We hypothesized that a probiotic would reduce abdominal pain in such patients. METHODS: We conducted a single-center, double-blind, placebo-controlled trial of probiotic treatment (Symprove) in adult patients with moderate-to-severe chronic, non-acute symptomatic diverticular disease. 143 patients were randomized to receive 1 mL/kg/day of probiotic liquid (N = 72) or placebo (N = 71) daily for 3 months. The primary endpoint was abdominal pain severity. Secondary endpoints consisted of the change in the frequency of eight abdominal symptoms and the level of intestinal inflammation (fecal calprotectin). RESULTS:120 patients completed the trial. Abdominal pain score, the primary end point, decreased in both groups, but no significant difference between the groups was found (P = 0.11). In relation to placebo, the probiotic significantly decreased the frequency of four of the eight secondary endpoints: constipation, diarrhea, mucorrhea, and back pain (P < 0.04). No significant differences were found in frequency of abdominal pain, PR bleeding, dysuria, and bloating. CONCLUSIONS: Multi-strain liquid probiotic did not improve abdominal pain scores significantly, but significantly improved the frequency of four other symptoms associated with chronic, non-acute symptomatic diverticular disease.
RCT Entities:
BACKGROUND:Diverticular disease is a significant burden on healthcare systems that is managed, surgically or medically, mainly as an emergency or acute condition. There are no standardized treatment recommendations for symptomatic uncomplicated disease. We hypothesized that a probiotic would reduce abdominal pain in such patients. METHODS: We conducted a single-center, double-blind, placebo-controlled trial of probiotic treatment (Symprove) in adult patients with moderate-to-severe chronic, non-acute symptomatic diverticular disease. 143 patients were randomized to receive 1 mL/kg/day of probiotic liquid (N = 72) or placebo (N = 71) daily for 3 months. The primary endpoint was abdominal pain severity. Secondary endpoints consisted of the change in the frequency of eight abdominal symptoms and the level of intestinal inflammation (fecal calprotectin). RESULTS: 120 patients completed the trial. Abdominal pain score, the primary end point, decreased in both groups, but no significant difference between the groups was found (P = 0.11). In relation to placebo, the probiotic significantly decreased the frequency of four of the eight secondary endpoints: constipation, diarrhea, mucorrhea, and back pain (P < 0.04). No significant differences were found in frequency of abdominal pain, PR bleeding, dysuria, and bloating. CONCLUSIONS: Multi-strain liquid probiotic did not improve abdominal pain scores significantly, but significantly improved the frequency of four other symptoms associated with chronic, non-acute symptomatic diverticular disease.
Authors: Sarah Y Boostrom; Bruce G Wolff; Robert R Cima; Amit Merchea; Eric J Dozois; David W Larson Journal: J Gastrointest Surg Date: 2012-06-13 Impact factor: 3.452
Authors: Jonas Ghyselinck; Lynn Verstrepen; Frédéric Moens; Pieter Van Den Abbeele; Arnout Bruggeman; Jawal Said; Barry Smith; Lynne Ann Barker; Caroline Jordan; Valentina Leta; K Ray Chaudhuri; Abdul W Basit; Simon Gaisford Journal: Int J Pharm X Date: 2021-07-02