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

NCT ID: NCT06781827

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-30

Brief Summary

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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

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Probiotic

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

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Probiotic

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

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gastroenterology Department of Jiangsu Province (Suqian)Hospital

Suqian, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huanhuan Chen, Doctor

Role: CONTACT

18351093039

Facility Contacts

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Huanhuan Chen, Doctor

Role: primary

18351093039

Other Identifiers

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WK20250106

Identifier Type: -

Identifier Source: org_study_id

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