Fecal Microbiota Transplantation for Ulcerative Colitis
Phase 2 / Phase 3 · Testing Fecal microbiota transplantation, Infusion of Saline and 5-Aminosalicylic acid(5-ASA)… · 1 site · Guangzhou First People's Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal microbiota transplantation (a procedure), Infusion of Saline (a procedure) and 5-Aminosalicylic acid(5-ASA) and/or Prednisone (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis and Fecal Microbiota Transplantation.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- Active, moderate to severe severity (Mayo score more than 6)
- Safety using history of 5-ASA
- Able to undergo endoscopy examination
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2019-01-20 (planned).
- Main results expected around 2028-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Clinical remission in patient as assessed using Mayo score (12 weeks)
In the researchers’ words
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency…
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 | Phase 2 / Phase 3 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Fecal Microbiota Transplantation |
| Lead sponsor | Guangzhou First People's Hospital |
| Enrollment | 120 (estimated) |
| Start date | 2019-01-20 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2019-01-15 |
| Last updated | 2019-01-15 |
| Official title | Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT03804931 |
Interventions
- Fecal microbiota transplantation (Procedure)
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine - Infusion of Saline (Procedure)
Infusion of Saline - 5-Aminosalicylic acid(5-ASA) and/or Prednisone (Drug)
Mesalazine and/or Prednisone
Full eligibility criteria (from the record)
Inclusion Criteria: * Active, moderate to severe severity (Mayo score more than 6) * Safety using history of 5-ASA * Able to undergo endoscopy examination Exclusion Criteria: * Antibiotic using in 7 days * High risk of toxic megacolon * Colon cancer or neoplasia in pathophysiology * Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Guangzhou First People's Hospital | Guangzhou, Guangdong | 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.