Using probiotics to help prevent and treat inflammatory bowel disease
Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel
NA · Wecare Probiotics Co., Ltd. · NCT06781827
This study is testing whether taking a probiotic called Lactobacillus reuteri can help people with inflammatory bowel disease feel better and manage their symptoms over eight weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wecare Probiotics Co., Ltd. (industry) |
| Locations | 1 site (Suqian, Jiangsu) |
| Trial ID | NCT06781827 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of oral Lactobacillus reuteri as an adjunct therapy for patients with inflammatory bowel disease (IBD) over an 8-week period. Participants will undergo endoscopic observation of intestinal inflammation at multiple time points, including 1, 3, 6, and 12 months post-treatment. The study will also involve collecting intestinal fluid for 16S RNA analysis to evaluate changes in gut microbiota, alongside peripheral blood tests and fecal calprotectin measurements to monitor disease progression.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been diagnosed with inflammatory bowel disease for at least 3 months but not more than 3 years.
Not a fit: Patients with other autoimmune diseases, serious comorbidities, or recent use of antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel adjunct therapy for managing inflammatory bowel disease, potentially improving patient outcomes.
How similar studies have performed: While the use of probiotics in IBD management has been explored, this specific approach with Lactobacillus reuteri is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 -
Where this trial is running
Suqian, Jiangsu
- Gastroenterology Department of Jiangsu Province （Suqian）Hospital — Suqian, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Huanhuan Chen, Doctor
- Email: 775804281@qq.com
- Phone: 18351093039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Bowel Disease