Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Maltodextrin.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel
Overview
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.
Interventions
- Dietary supplement Probiotic
The experimental phase of the study lasts 8 weeks and each patient will be visited 4 times (January, March, June, and December). - 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).
Primary outcome measures
- Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System [Time frame: 12 months]
Secondary outcome measures (4)
- Assessment of Intestinal Flora Changes Using 16S RNA Analysis [Time frame: 8 weeks]
- Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers [Time frame: 8 weeks]
- Disease progression [Time frame: 8 weeks]
- Evaluation of Crohn's Disease Severity Using the Crohn's Disease Activity Index (CDAI) [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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 -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Gastroenterology Department of Jiangsu Province （Suqian）Hospital — Suqian
Identifiers
NCT: NCT06781827 · WK20250106