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NCT03747718
Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children
Phase 1 trial testing Fecal Microbiota Transplantation in Crohn Disease. Withdrawn.
1 December 2024
Quick facts
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 1 December 2022 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fecal Microbiota Transplantation — full drug profile →
- Placebo
Conditions studied
- Crohn Disease — all drugs for Crohn Disease →
Sponsor
Stanford University
Who can join
Adults 2 to 25, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
NCT02108821 Primary goal: -To determine the safety of fecal transplant by colonoscopy and retention enemas for induction followed by maintenance retention fecal vs. placebo enemas in children and young adults with uncomplicated mild-moderately active Crohn's disease. Secondary goals: * Assess efficacy of this induction regimen followed by maintenance fecal or placebo transplants in responders. The efficacy will be assessed by clinical evaluation and fecal calprotectin that is a non-invasive biomarker. * Correlate subject's baseline microbiome findings with likelihood for response to FMT induction therapy. * Follow the chronological microbiome shifts after transplant and correlate with response using clinical and calprotectin assessment in the two groups.
Publications & conference data
2 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
Verify or expand the search:
- PubMed search for NCT03747718
- 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.
- NCT07464392 — FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis · NA · recruiting
- NCT07454408 — Evaluation of the Outcome of Fecal Microbiota Transplantation · Phase 1, PHASE2 · not yet recruiting
- NCT07463248 — PULSAR Combined With Fecal Microbiota Transplantation for Advanced Hepatocellular Carcinoma Progressing After First-Line · Phase 2 · not yet recruiting
- NCT07042438 — Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Expo · Phase 2 · recruiting
- NCT06744751 — A Study on the Effects of Combined FMT on Gut Microbiota and Eating Disorder Symptoms in AN · NA · not yet recruiting
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
- NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
- NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
- NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
Other Stanford University trials
Trials by the same sponsor.
- NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
- NCT04225949 — Patients Understanding of PROM Graphs · NA · withdrawn
- NCT06273098 — School-Based Bladder Health Intervention · NA · withdrawn
- NCT04652635 — Management of Nailbed Injuries · NA · withdrawn
- NCT05443503 — Stanford Spine Keeper - Managing Your Low Back Pain · NA · suspended
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 NCT03747718 (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 Stanford University
- Last refreshed: 14 April 2023
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/NCT03747718.
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