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Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease

NCT06781827 · Wecare Probiotics Co., Ltd.
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Official title
Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel
About this study
This project involves the use of oral Lactobacillus reuteri as an adjunct therapy for 8 weeks. Endoscopic observation of intestinal inflammation will be conducted at 1 month, 3 months, 6 months, and 12 months after the administration of the drug. Intestinal fluid will be collected endoscopically for 16S RNA analysis to assess changes in the gut microbiota. Inflammatory changes in the patients will be detected through peripheral blood tests, and fecal calprotectin levels will be measured to evaluate the progression of the disease.
Eligibility criteria
Inclusion Criteria: 1. Be over 18 years old 2. Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years - Exclusion Criteria: 1. Does not meet the diagnostic criteria of CD 2. Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc 3. Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness 4. Patients with suspected cancer in their intestines 5. Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery) 6. There is currently an infection 7. He has had cancer in the last 5 years -
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-01-01
Estimated completion: 2025-12-30
Last updated: 2025-04-04
Interventions
Dietary Supplement: ProbioticDietary Supplement: Maltodextrin
Primary outcomes
  • Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System (12 months)
Sponsor
Wecare Probiotics Co., Ltd. · industry
Contacts & investigators
ContactHuanhuan Chen, Doctor · contact · 775804281@qq.com · 18351093039
All locations (1)
Gastroenterology Department of Jiangsu Province (Suqian)HospitalRecruiting
Suqian, Jiangsu, China