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NCT06333405
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
NA trial testing Fecal Microbiota Transplantation in Necrotizing Enterocolitis in 20 participants. Status unknown.
31 January 2025
Quick facts
| Lead sponsor | Medical University of Warsaw |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 20 |
| Start date | 1 May 2024 |
| Primary completion | 31 January 2025 |
| Estimated completion | 31 January 2025 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Fecal Microbiota Transplantation — full drug profile →
Conditions studied
- Necrotizing Enterocolitis — all drugs for Necrotizing Enterocolitis →
Sponsor
Medical University of Warsaw
Who can join
Adults 24 Weeks to 36 Weeks, any sex, with Necrotizing Enterocolitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to assess the safety of fecal microbiota transplantation (FMT) as a preventive method for the development of Necrotizing enterocolitis (NEC) in a group of premature infants. This is the first stage of a clinical trial testing the effectiveness of FMT in NEC, the aim of which is to examine the safety profile and analyze all side effects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Review: microbial metabolites - a key to address gut inflammation and barrier dysfunction in the premature infant.
Robertson KM, Cermack K, Woodruff T, Carter SR, et al · · 2025 · cited 1× · PMID 40887742 · DOI 10.1080/19490976.2025.2551117 -
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC)-Protocol for a Safety Study.
Bieganska EA, Wolski M, Zarlenga M, Bilinski J, et al · · 2026 · PMID 41901284 · DOI 10.3390/ph19030437
Verify or expand the search:
- PubMed search for NCT06333405
- 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 Necrotizing Enterocolitis
Currently open trials in the same condition.
- NCT06681129 — Study of Normal Intestinal Development and Disease in Premature and Term Neonates · recruiting
- NCT06672913 — Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study · NA · recruiting
- NCT06908239 — Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants · NA · active not recruiting
- NCT06032676 — Qualitative Study of Surgeons With Prospective Patient Follow-up · recruiting
- NCT05272579 — PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants · EARLY_PHASE1 · recruiting
Other Medical University of Warsaw trials
Trials by the same sponsor.
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- NCT07511907 — Routine Intraoperative White Test for Bile Leak Detection in Liver Resection · NA · not yet recruiting
- NCT07498660 — PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomize · NA · not yet recruiting
- NCT07398898 — Use of Augmented Reality Glasses and Noise-Cancelling Headphones to Reduce Dental Anxiety in Adult Patients · NA · recruiting
- NCT07237204 — 15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial · NA · not yet recruiting
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 NCT06333405 (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 Medical University of Warsaw
- Last refreshed: 27 March 2024
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/NCT06333405.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing