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

NCT06781827 | Recruiting

• 1 other identifier: WK20250106
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of Intestinal Flora Changes Using 16S RNA Analysis

  8 weeks

• Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers

  8 weeks

• Disease progression

  8 weeks

• Evaluation of Crohn's Disease Severity Using the Crohn's Disease Activity Index (CDAI)

  8 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Daily intervention with Limosilactobacillus reuteri LR08 (10 billion CFU, 2g) for 8 weeks, stored in a cool and dry place.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.

Dietary Supplement: Maltodextrin

Interventions

Probiotic DIETARY_SUPPLEMENT

The experimental phase of the study lasts 8 weeks and each patient will be visited 4 times (January, March, June, and December).

Probiotic

Maltodextrin DIETARY_SUPPLEMENT

The experimental phase of this study had last 8 weeks and each patient will make 4 visits (January, March, June, and December).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be over 18 years old
• Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -

You may not qualify if:

• Does not meet the diagnostic criteria of CD
• 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
• Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness
• Patients with suspected cancer in their intestines
• Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery)
• There is currently an infection
• He has had cancer in the last 5 years -

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Gastroenterology Department of Jiangsu Province （Suqian）Hospital

Suqian, Jiangsu, 223800, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Huanhuan Chen, Doctor

CONTACT

18351093039; 775804281@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 17, 2025
• Study Start: January 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

CN (1)