The effect of probiotics on functional constipation in adults: Double-blind, randomized, placebo-controlled study

Abstract

Background: Evacuation disorders are common in industrialized countries, affecting an average of 15% to 20% of the healthy adult population. Probiotic therapy can reduce functional constipation and increase both the number of weekly bowel movements and quality of stools. Based on the hypothesis that a combination of more strains may provide better results for constipation and facilitate adherence to treatment, this study will evaluate the efficacy and safety of a combination of different strains of Lactobacillus sp. and Bifidobacterium sp. in functional constipation.Methods: A single-centre trial of adults aged 20 to 80 years with intestinal constipation will be conducted at a Gastroenterology Clinic in Sorocaba, State of São Paulo, Brazil. Participants will be allocated into 3 groups receiving:1.mixture of 3 probiotics: [Lactobacillus acidophilus, Bifidobacterium bifidum, and Lactobacillus rhamnosus (3 × 109CFU)];2.mixture of 8 probiotics [Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus defensis, Bifidobacterium animallis (8 × 109CFU)]; or3.placebo, for 4 weeks.The outcomes of interest will be change in frequency of weekly bowel movements, change in stool quality according to the 4-6 Bristol scale, number of volunteer withdrawal, number of adverse events and number of serious adverse effect.Discussion:The probiotic products are expected to induce beneficial changes in the intestinal microbiota, thereby increasing intestinal frequency to over 3 times a week and improving stool quality. The results can guide patients and healthcare practitioners and help in decision-making in the treatment of functional constipation.Trial registration and registry name:ClinicalTrials.gov Identifier: NCT04437147: The Effect of Probiotics on Functional Constipation in Adults: Study protocol for Double blind, Randomized, Placebo controlled StudyProtocol Version:Version 01 August 30, 2020.