RecruitingNot ApplicableNCT06781827

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


Sponsor

Wecare Probiotics Co., Ltd.

Enrollment

50 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 -

Exclusion Criteria7

  • 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 -

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Interventions

DIETARY_SUPPLEMENTProbiotic

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

DIETARY_SUPPLEMENTMaltodextrin

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


Locations(1)

Gastroenterology Department of Jiangsu Province (Suqian)Hospital

Suqian, Jiangsu, China

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NCT06781827


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