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

Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huanhuan Chen, Doctor; Phone Number: 18351093039; Email: 775804281@qq.com

Study Locations

• China
  • Jiangsu
    • Suqian, Jiangsu, China, 223800
      • Recruiting
      • Gastroenterology Department of Jiangsu Province （Suqian）Hospital
      • Contact: Huanhuan Chen, Doctor; Phone Number: 18351093039; Email: 775804281@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.	Dietary supplement: Maltodextrin; The experimental phase of this study had last 8 weeks and each patient will make 4 visits (January, March, June, and December).
Experimental: Probiotic; Daily intervention with Limosilactobacillus reuteri LR08 (10 billion CFU, 2g) for 8 weeks, stored in a cool and dry place.	Dietary supplement: Probiotic; The experimental phase of the study lasts 8 weeks and each patient will be visited 4 times (January, March, June, and December).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Intestinal Flora Changes Using 16S RNA Analysis	Part of the intestinal fluid was collected under endoscope, and 16S RNA analysis was conducted to evaluate the changes in the intestinal flora composition.	8 weeks
Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers	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.	8 weeks
Disease progression	The progress of the disease was assessed by collecting fecal samples to detect the change of calcarein	8 weeks
Evaluation of Crohn's Disease Severity Using the Crohn's Disease Activity Index (CDAI)	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.	8 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: WK20250106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No