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.
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Acknowledgements
We thank the patients and staff at the Diverticular Disease clinic at King’s College Hospital, especially Ingvar Bjarnason for his assistance.
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Guarantor of the article: Mr. Savvas Papagrigoriadis. Specific author contributions: Study conception and design: CK, IB, and SP. Acquisition of data: CK, IB, RS, and SP. Analysis and interpretation of data: CK, IB, AND, RS, and SP. Drafting of article: CK, IB, and SP. Critical revision for important intellectual content: CK, IB, AND, RS, and SP. Final approval of version to be published: CK, IB, AND, RS, and SP. All authors approved the final version of the manuscript.
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Ingvar Bjarnason has served as a speaker and advisor board member for Symprove Ltd. Authors CLK, SP, and IB worked on this clinical trial of a probiotic, Symprove, funded by King’s College Hospital, London, via an unrestricted research grant from Symprove Ltd. No funding or other support was obtained for the writing of this manuscript.
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Kvasnovsky, C.L., Bjarnason, I., Donaldson, A.N. et al. A randomized double-blind placebo-controlled trial of a multi-strain probiotic in treatment of symptomatic uncomplicated diverticular disease. Inflammopharmacol 25, 499–509 (2017). https://doi.org/10.1007/s10787-017-0363-y
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DOI: https://doi.org/10.1007/s10787-017-0363-y