Usefulness of Bifidobacterium longum BB536 in Elderly Individuals With Chronic Constipation: A Randomized Controlled Trial.

"CONFLICTS OF INTEREST Guarantors of the article: Tsutomu Takeda, MD, PhD, Jin-Zhong Xiao, PhD, and Toshifumi Ohkusa, MD, PhD, AGAF. Specific author contributions: T.T., D.A., and T. Ohkusa: designed the study. T.T. and D.A.: recruited the patients, collected the data, and performed the analyses. T. Osada: allocated the cases. S.K., N.K., T. Odamaki, and J.X.: analyzed the fecal microbiota. S.N., N.Y., and Y.N.: performed the statistical analyses. S.N., N.Y., and Y.N.: performed the statistical analyses. T.T.: prepared the initial manuscript; D.A. and T. Ohkusa: revised the manuscript; and A.N. and N.S.: supervised the study. All authors read and approved the final manuscript. Financial support: Funding was provided by the Department of Microbiota Research, Juntendo University Graduate School of Medicine. Potential competing interests: T.T., D.A., S.K., N.K., T.O., J.X., T.O., and N.S. are members of the Department of Microbiota Research, Juntendo University Graduate School of Medicine. Clinical trial registration: This study protocol was registered on UMIN-CTR (https://www.umin.ac.jp/icdr/index.html), and the trial identification number is UMIN 000033031. Institutional review board statement: This study was conducted in compliance with the Declaration of Helsinki (Fortaleza, Brazil 2013) and the Ethical Guidelines for Medical Research Involving Human Subjects (2014) of the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labor and Welfare. This study protocol was approved by the Ethics Committee of Juntendo Tokyo Koto Geriatric Medical Center Institutional Review Board (No. 98-3). Informed consent statement: Informed consent was obtained from all subjects involved in the study. Written informed consent was obtained from the patients to publish this paper. Data availability statement: The data sets and materials in this study are available from the corresponding author. Study HighlightsWHAT IS KNOWN✓ Chronic constipation increases with age.✓ Conventional laxatives have many side effects, and when used continuously, they become resistant, and their effects are diminished.✓ Previous studies have reported the efficacy of probiotics for chronic constipation and have fewer side effects.✓ Few reports exist regarding the therapeutic effects of probiotics on chronic constipation in elderly individuals.WHAT IS NEW HERE✓ This study is the first randomized controlled trial evaluating Bifidobacterium longum for chronic constipation in elderly outpatients.✓ Significant improvement was observed in the changed values of frequency of bowel movements after 4 weeks of B. longum intake compared with the placebo group.✓ Marked changes in the gut microbiota composition were not found after the treatment intake, suggesting that bacterial components and metabolites of B. longum, rather than the changes in microbiota, may affect defecation."

"Financial support: Funding was provided by the Department of Microbiota Research, Juntendo University Graduate School of Medicine."

"This study was performed with the approval of the ethical committee of Juntendo University and was based on the tenets of the Declaration of Helsinki. Informed consent was obtained from each participant. This study is registered at the University Hospital Medical Research Network, number UMIN000033031."