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 Sao Paulo, Brazil. Participants will be allocated into 3 groups receiving: 1. mixture of 3 probiotics: [, , and (3 x 109 CFU)]; 2. Lactobacillus acidophilusBifidobacterium bifidumLactobacillus rhamnosusmixture of 8 probiotics [, , , , , , (8 x 109 CFU)]; or 3. Lactobacillus acidophilusBifidobacterium bifidumLactobacillus rhamnosus, Lactobacillus paracaseiBifidobacterium longumBifidobacterium lactisLactobacillus defensisBifidobacterium animallisplacebo, 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. Protocol Version: Version 01 August 30, 2020.