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

NCT06781827 — Not applicable, Completed, 41 participants, Wecare Probiotics Co., Ltd.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel

Registry	NCT06781827
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	41 (Actual)
Sponsor	Wecare Probiotics Co., Ltd. (Industry)
Conditions	Inflammatory Bowel Disease
Interventions	Probiotic (Dietary supplement)
Dates	start 2025-01-01, primary completion 2026-03-30, completion 2026-06-30, first posted 2025-01-17, last updated 2026-10-19
Locations	1 site in China

-Summary

This study evaluates oral Lactobacillus reuteri as an adjunct therapy for 2 months. Endoscopic assessments will be performed at baseline and after 2 months of intervention to evaluate intestinal inflammation. Intestinal fluid samples will be collected during endoscopy for 16S rRNA gene sequencing to assess changes in the gut microbiota. Peripheral blood inflammatory markers and fecal calprotectin levels will also be measured to evaluate changes in intestinal inflammation.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Probiotic	Experimental	Dietary Supplement: Probiotic	Daily intervention with Limosilactobacillus reuteri LR08 (10 billion CFU) for 8 weeks, stored in a cool and dry place.

Probiotic (Dietary supplement): The experimental phase of the study lasts 8 weeks and each patient will be visited 4 times.

+Outcome measures

Primary outcomes

Change in Intestinal Inflammation [8 weeks]: The intestinal inflammation will be assessed using the Endoscopic Scoring System.

+Eligibility

Sex: All, ages: 18 Years to any

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 -

+Locations (1)

Facility	City	Country	Status
Gastroenterology Department of Jiangsu Province （Suqian）Hospital	Suqian, Jiangsu	China