Actively Recruiting
Study of Oral Lactobacillus Reuteri for Preventing and Treating Inflammatory Bowel Disease in Adults
Led by Wecare Probiotics Co., Ltd. · Updated on 2025-04-04
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to study the use of oral Lactobacillus reuteri as an additional therapy for people with Inflammatory Bowel Disease IBD. The study evaluates changes in intestinal inflammation and gut microbiota over a period of 12 months, with a focus on understanding disease progression and inflammatory changes using blood and stool tests. The study is sponsored by Wecare Probiotics Co., Ltd and involves randomized assignment to treatment groups. Participants will receive either a daily probiotic intervention with Limosilactobacillus reuteri LR08 10 billion CFU, 2 grams or a placebo of maltodextrin 3 grams for 8 weeks. Both interventions are stored in a cool, dry place. The study includes scheduled visits at 1 month, 3 months, 6 months, and 12 months after starting the treatment to conduct endoscopic observations and collect intestinal fluid for 16S RNA analysis. During the study, participants will undergo endoscopic examinations to assess intestinal inflammation using an endoscopic scoring system. Blood tests will measure inflammatory markers, and stool samples will be analyzed for calprotectin levels to monitor disease progression. The Crohns Disease Activity Index CDAI will also be used to evaluate disease severity. The total follow-up period extends to 12 months to capture longer-term effects and safety.
CONDITIONS
Brief Title
Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease
Research Team
H
Huanhuan Chen, Doctor
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