Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease
Not applicable · Testing Probiotic and Maltodextrin · 1 site · Wecare Probiotics Co., Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Probiotic (a dietary supplement) and Maltodextrin (a dietary supplement) to see if it can prevent disease or complications. Condition(s) listed: Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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 -
There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2025-01-01.
- Main results expected around 2025-10-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System (12 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease |
| Lead sponsor | Wecare Probiotics Co., Ltd. |
| Enrollment | 50 (estimated) |
| Start date | 2025-01-01 |
| Primary completion (est.) | 2025-10-30 |
| First posted | 2025-01-17 |
| Last updated | 2025-04-04 |
| Official title | Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel |
| ClinicalTrials.gov ID | NCT06781827 |
Interventions
- Probiotic (Dietary Supplement)
The experimental phase of the study lasts 8 weeks and each patient will be visited 4 times (January, March, June, and December). - Maltodextrin (Dietary Supplement)
The experimental phase of this study had last 8 weeks and each patient will make 4 visits (January, March, June, and December).
Full eligibility criteria (from the record)
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)
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology Department of Jiangsu Province （Suqian）Hospital | Suqian, Jiangsu | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.