Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 6, 2023; 11(19): 4612-4624
Published online Jul 6, 2023. doi: 10.12998/wjcc.v11.i19.4612
Fecal microbiota transplantation in patients with metabolic syndrome and obesity: A randomized controlled trial
Alberto Machado da Ponte Neto, Aniele Cristine Ott Clemente, Paula Waki Rosa, Igor Braga Ribeiro, Mateus Pereira Funari, Gabriel Cairo Nunes, Luana Moreira, Luiz Gustavo Sparvoli, Ramon Cortez, Carla Romano Taddei, Márcio C Mancini, Eduardo Guimarães Hourneaux de Moura
Alberto Machado da Ponte Neto, Igor Braga Ribeiro, Mateus Pereira Funari, Gabriel Cairo Nunes, Eduardo Guimarães Hourneaux de Moura, Departament of Gastroenterology, Faculdade de Medicina, Universidade de Sao Paulo, Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas HCFMUSP, São Paulo 05403-010, SP, Brazil
Aniele Cristine Ott Clemente, Paula Waki Rosa, Márcio C Mancini, Department of Endocrinology, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo 05403-010, SP, Brazil
Luana Moreira, Luiz Gustavo Sparvoli, Ramon Cortez, Carla Romano Taddei, Department of Clinical and Toxicology Analysis, School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05403-010, SP, Brazil
Carla Romano Taddei, School of Arts, Science and Humanities, University of São Paulo, São Paulo 05403-010, SP, Brazil
Author contributions: da Ponte Neto AM contributed to the conception and design of the study, analyzed and interpreted the data, drafted the article; revised the article for important intellectual content, and approved the final version; Clemente ACO analyzed and interpreted the data, revised the article for important intellectual content, and approved the final version; Rosa PW analyzed and interpreted the data, drafted the article, revised the article for important intellectual content, and approved the final version; Ribeiro IB contributed to the conception and design of the study, analyzed and interpreted the data, drafted the article; revised the article for important intellectual content, and approved the final version; Nunes GC analyzed and interpreted the data, revised the article for important intellectual content, and approved the final version; Moreira L analyzed and interpreted the data, and approved the final version; Sparvoli LG analyzed and interpreted the data, drafted the article, revised the article for important intellectual content, and approved the final version; Cortez R analyzed and interpreted the data, drafted the article, revised the article for important intellectual content, and approved the final version; Taddei CR analyzed and interpreted the data, drafted the article, revised the article for important intellectual content, and approved the final version; Mancini M analyzed and interpreted the data, drafted the article, revised the article for important intellectual content, and approved the final version; De Moura EGH: analyzed and interpreted the data, drafted the article, revised the article for important intellectual content, and approved the final version.
Institutional review board statement: The study was approved by the Research Ethics Committee of the University of São Paulo School of Medicine, Approval No. CAAE: 62319916.9.0000.0068.
Clinical trial registration statement: The trial was registered at ensaiosclinicos.gov.br (identifier: U1111-1223-6951).
Informed consent statement: All subjects agreed to participate in this study after informed consent and ethical permission was obtained.
Conflict-of-interest statement: All the authors declare that they have no conflicts of interest related to this manuscript.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Igor Braga Ribeiro, MD, PhD, Associate Research Scientist, Attending Doctor, Doctor, Research Scientist, Departament of Gastroenterology, Faculdade de Medicina, Universidade de Sao Paulo, Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas HCFMUSP, Av. Dr Enéas de Carvalho Aguiar, 225, 6o andar, bloco 3, Cerqueira Cesar, São Paulo 05403-010, SP, Brazil. igorbraga1@gmail.com
Received: January 10, 2023
Peer-review started: January 10, 2023
First decision: January 21, 2023
Revised: January 26, 2023
Accepted: May 4, 2023
Article in press: May 4, 2023
Published online: July 6, 2023
Processing time: 171 Days and 10.5 Hours
Abstract
BACKGROUND

Metabolic syndrome is a multifactorial disease, and the gut microbiota may play a role in its pathogenesis. Obesity, especially abdominal obesity, is associated with insulin resistance, often increasing the risk of type two diabetes mellitus, vascular endothelial dysfunction, an abnormal lipid profile, hypertension, and vascular inflammation, all of which promote the development of atherosclerotic cardiovascular disease.

AIM

To evaluate the outcomes of fecal microbiota transplantation (FMT) in patients with metabolic syndrome.

METHODS

This was a randomized, single-blind placebo-controlled trial comparing FMT and a sham procedure in patients with metabolic syndrome. We selected 32 female patients, who were divided into eight groups of four patients each. All of the patients were submitted to upper gastrointestinal endoscopy. In each group, two patients were randomly allocated to undergo FMT, and the other two patients received saline infusion. The patients were followed for one year after the procedures, during which time anthropometric, bioimpedance, and biochemical data were collected. The patients also had periodic consultations with a nutritionist and an endocrinologist. The primary end point was a change in the gut microbiota.

RESULTS

There was evidence of a postprocedural change in microbiota composition in the patients who underwent FMT in relation to that observed in those who underwent the sham procedure. However, we found no difference between the two groups in terms of the clinical parameters evaluated.

CONCLUSION

There were no significant differences in biochemical or anthropometric parameters, between the two groups evaluated. Nevertheless, there were significant postprocedural differences in the microbiota composition between the placebo group. To date, clinical outcomes related to FMT remain uncertain.

Keywords: Fecal microbiota transplantation; Metabolic syndrome; Obesity; Endoscopy; Diabetes mellitus; Endocrinology

Core Tip: The prevalence of metabolic syndrome is a pandemic that goes hand in hand with obesity and diabetes, affecting almost half of the world's population. Therapeutic approaches targeting dysbiosis and manipulation of the gut microbiome have become options and are being tested. Such approaches include the use of prebiotics, probiotics, synbiotics, antibiotics and fecal microbiota transplantation (FMT). It is known that FMT can alter the intestinal microbiota and increase its diversity, resulting in a microbiome that can help decrease body fat and increase insulin sensitivity, as well as facilitate the treatment of metabolic syndrome and obesity. This was a randomized controlled trial comparing FMT and a sham procedure in patients with the metabolic syndrome.