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NCT03804931
Fecal Microbiota Transplantation for Ulcerative Colitis
Phase 2, PHASE3 trial testing Fecal microbiota transplantation in Ulcerative Colitis in 120 participants. Currently enrolling.
31 December 2028
Quick facts
| Lead sponsor | Guangzhou First People's Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 20 January 2019 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fecal microbiota transplantation — full drug profile →
- Infusion of Saline
- 5-Aminosalicylic acid(5-ASA) and/or Prednisone — full drug profile →
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Fecal Microbiota Transplantation — all drugs for Fecal Microbiota Transplantation →
Sponsor
Guangzhou First People's Hospital
Who can join
Adults 18 to 65, any sex, with Ulcerative Colitis or Fecal Microbiota Transplantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z -
Fecal microbiota transplantation beyond Clostridioides difficile infections.
Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066 -
Fecal transplantation for treatment of inflammatory bowel disease.
Imdad A, Pandit NG, Zaman M, Minkoff NZ, et al · · 2023 · cited 51× · PMID 37094824 · DOI 10.1002/14651858.cd012774.pub3
Verify or expand the search:
- PubMed search for NCT03804931
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal microbiota transplantation
Trials testing the same drug.
- NCT07149441 — Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study · NA · active not recruiting
- NCT06478602 — Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis · Phase 3 · completed
- NCT06290258 — Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder. · Phase 1, PHASE2 · recruiting
- NCT05873348 — A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19. · NA · completed
- NCT06268990 — FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT · NA · recruiting
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Guangzhou First People's Hospital trials
Trials by the same sponsor.
- NCT07296731 — Anxiety in Cataract Patients Using Preoperative Music Therapy · NA · active not recruiting
- NCT05952466 — Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China · completed
- NCT05698758 — Intranasal Dexmedetomidine for Adult Patients Undergoing Phacoemulsification Cataract Surgery · NA · unknown
- NCT05034029 — Effect of Metformin on Patients With Osteoarthritis · NA · unknown
- NCT04837313 — Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03804931 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guangzhou First People's Hospital
- Last refreshed: 15 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03804931.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing