Efficacy of Probiotics in Patients With IBD
Not applicable · Testing probiotics · 1 site · The First Affiliated Hospital of Xinxiang Medical College
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing probiotics (a dietary supplement) as supportive care (to help with symptoms or quality of life). Condition(s) listed: Ulcerative Colitis and Irritable Bowel Syndrome.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- Clinical diagnosis of ulcerative colitis
- Clinical diagnosis of irritable bowel
- Can swallow probiotic pellets as required
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2022-07-31.
- Main results expected around 2024-01-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Changes of intestinal flora (4-12 weeks)
In the researchers’ words
This research group plans to take patients with mild to moderate UC and diarrhea IBS diagnosed in the First Affiliated Hospital of Xinxiang Medical College as examples, and divide them into UC group and IBS group; Each group was randomly divided into two groups, namely, conventional treatment+probiotics group and conventional treatment+probiotics placebo group.Starting from the intervention of probiotics on…
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 | Ulcerative Colitis; Irritable Bowel Syndrome |
| Lead sponsor | The First Affiliated Hospital of Xinxiang Medical College |
| Enrollment | 200 (estimated) |
| Start date | 2022-07-31 |
| Primary completion (est.) | 2024-01-31 |
| First posted | 2022-12-15 |
| Last updated | 2022-12-15 |
| Official title | Clinical Efficacy and Mechanism of Probiotics in the Adjuvant Treatment of Ulcerative Colitis and Irritable Bowel Syndrome |
| ClinicalTrials.gov ID | NCT05652621 |
Interventions
- probiotics (Dietary Supplement)
Resistant dextrin (water-soluble dietary fiber), Lactobacillus reuteri PLBK1, Luo Lactobacillus delbrueckii, Lactobacillus griffii PLBK3, Lactobacillus acidophilus PLBK4, Bifidobacterium lactis PLBK5）
Full eligibility criteria (from the record)
Inclusion Criteria: * Clinical diagnosis of ulcerative colitis * Clinical diagnosis of irritable bowel * Can swallow probiotic pellets as required Exclusion Criteria: * indeterminate colitis,suspected IBD
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Xinxiang Medical College | Xinxiang, Henan | 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.