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

Wecare Probiotics

Status: Enrolling

Conditions: Inflammatory Bowel Disease

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06781827

WK20250106

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin