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

Author(s)

Rosa Mitelmao, Fabiana Cristina ^[1] ; Bergamaschi, Cristiane de Cassia ^[1] ; Gerenutti, Marli ^[2] ; Hachel, Karin ^[3] ; Silva, Marcus Tolentino ^[1] ; Balcao, Victor M. ^{[4, 5, 1]} ; Duarte Carvalho Vila, Marta Maria ^[1]

Affiliation

^[1] Univ Sorocaba, PhageLab Lab Biofilms & Bacteriophages, Sorocaba - Brazil

^[2] Pontifical Catholic Univ Sao Paulo, Sorocaba - Brazil

^[3] Clin Gastroenterol Dr Karin Hackel, Sorocaba - Brazil

^[4] Univ Aveiro, Dept Biol, Campus Univ Santiago, P-3810193 Aveiro - Portugal

^[5] Univ Aveiro, CESAM, Campus Univ Santiago, P-3810193 Aveiro - Portugal

• Document type: Journal article
• Source: MEDICINE; v. 100, n. 10 MAR 12 2021.
• Web of Science Citations: 1

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. (AU)

• FAPESP's process: 16/12234-4 - TransAppIL - Transdermal delivery of structurally and functionally stabilized protein entities applying ionic liquids.
• Grantee: Marta Maria Duarte Carvalho Vila
• Support Opportunities: Regular Research Grants
• FAPESP's process: 16/08884-3 - PneumoPhageColor - development of a colorimetric biodetection kit for Pseudomonas aeruginosa based on phage particles
• Grantee: Vitor Manuel Cardoso Figueiredo Balcão
• Support Opportunities: Regular Research Grants
• FAPESP's process: 18/05522-9 - PsaPhageKill - isolation, characterisation and use of lytic bacteriophages against Pseudomonas syringae PV. actinidiae to fight the cancer of kiwifruit: an efficient and ecofriendly alternative
• Grantee: Vitor Manuel Cardoso Figueiredo Balcão
• Support Opportunities: Scholarships abroad - Research