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

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT06781827
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System	12 months	The intestinal inflammation will be assessed using the Endoscopic Scoring System, which will be observed under endoscope at 1 month, 3 months, 6 months, and 12 months after the administration of the drug.

Secondary Outcome Measures

Name	Time	Method
Assessment of Intestinal Flora Changes Using 16S RNA Analysis	8 weeks	Part of the intestinal fluid was collected under endoscope, and 16S RNA analysis was conducted to evaluate the changes in the intestinal flora composition.
Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers	8 weeks	The inflammatory changes were detected by analyzing peripheral blood for specific inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and other relevant cytokines.
Disease progression	8 weeks	The progress of the disease was assessed by collecting fecal samples to detect the change of calcarein
Evaluation of Crohn's Disease Severity Using the Crohn's Disease Activity Index (CDAI)	8 weeks	The Crohn's Disease Activity Index (CDAI) was used to evaluate the disease severity of CD. The CDAI score ranges from 0 to 600, with higher scores indicating more severe disease. The index is calculated by combining the daily frequency of bowel movements, abdominal pain score (0-10), general well-being (0-7), and the presence of abdominal mass (0-2). Additionally, the Simple Endoscopic Score for Crohn's Disease (SES-CD) was used for endoscopic scores, which ranges from 0 to 42, with higher scores indicating more severe endoscopic findings.

Trial Locations

Locations (1)

Gastroenterology Department of Jiangsu Province （Suqian）Hospital; 🇨🇳 Suqian, Jiangsu, China