CLINICAL TRIAL article

Front. Nutr.

Sec. Nutrition and Microbes

Volume 12 - 2025 | doi: 10.3389/fnut.2025.1542145

Effect of Bacillus coagulans BC99 Supplementation on Body Weight and Gut Microbiota in Overweight and Obese Individual: A Randomized, Double-blind, Placebo-controlled Study

Provisionally accepted
  • 1Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, China
  • 2Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital of Shandong University, Jinan, Shandong, China
  • 3Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
  • 4Robot Engineering Laboratory for Precise Diagnosis and Therapy of GI Tumor, Qilu Hospital, Cheeloo College of Medicine, Shandong University,, Jinan, Shandong Province, China

The final, formatted version of the article will be published soon.

Introduction: Probiotic supplementation is a safe and effective way to reduce overweight and obesity by regulating the gut microbiota. The Bacillus coagulans strain BC99 is derived from humans and has various probiotic-related, acid resistance, bile salt resistance, and adhesion-related domains in the genome. This study aimed to assess the effects of BC99 on the gut microbiota, body weight and lipid profiles of overweight and obese individuals. Methods: A total of 66 adult individuals were randomly assigned to a probiotic group (supplemented with 5 × 109 colony-forming units of BC99 per day along with 3 g of maltodextrin) and placebo group (supplemented with 3 g of maltodextrin daily) in a 1:1 ratio. Results: After 8 weeks of oral administration, BC99 intervention significantly decreased the body weight of overweight individual (P<0.01). Weight loss was significantly greater in the probiotic group than in the placebo group (P<0.05). No significant differences were observed in lipid profiles between two groups. The microbiota analysis revealed that BC99 intervention significantly improved the β-diversity at week 4. The genus Parabacteroides was negatively correlated with body weight and was found to be enriched in the BC99 group. Discussion: These findings suggest that B. coagulans strain BC99 could be a beneficial candidate for modulating the gut microbiota and improve body weight management for overweight individuals. Clinical trial registration: ClinicalTrials.gov, identifier NCT06077383.

Keywords: B. coagulans, Gut Microbiota, Overweight, obese, Probiotics

Received: 10 Dec 2024; Accepted: 10 Apr 2025.

Copyright: © 2025 Wang, Zhang, Wang, Xing, Li and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Zhen Li, Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, China
Lixiang Li, Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, China

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