NCT03804931 Fecal Microbiota Transplantation for Ulcerative Colitis
| NCT ID | NCT03804931 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Guangzhou First People's Hospital |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2019-01-20 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2019-01-20 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 and safety of FMT in patients with ulcerative colitis(UC).
Eligibility Criteria
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)
Contact & Investigator
Yuqiang Nie, MD
PRINCIPAL INVESTIGATOR
Guangzhou First People's Hospital
Frequently Asked Questions
Who can join the NCT03804931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03804931 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03804931 currently recruiting?
Yes, NCT03804931 is actively recruiting participants. Contact the research team at honglisums@126.com for enrollment information.
Where is the NCT03804931 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT03804931 clinical trial?
NCT03804931 is sponsored by Guangzhou First People's Hospital. The principal investigator is Yuqiang Nie, MD at Guangzhou First People's Hospital. The trial plans to enroll 120 participants.
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