An interventional study of Fecal Microbiota Transplantation in Necrotizing Enterocolitis (NEC) and Necrotizing Enterocolitis of Newborn, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 24 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Prevention
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.
Necrotizing enterocolitis (NEC) is an inflammatory disease with an incidence of about 1 in 1,000 live births, much higher in premature and low birth weight newborns. Mortality in this disease reaches about 15-30% and has remained stable for many years. Intestinal dysbiosis is an important element of the pathogenesis of this disease and for this reason, experimental models have been used to administer fecal microbiota transplantation (FMT) for prophylaxis and treatment of NEC with very satisfactory results. The aim of the study is to investigate the safety of FMT in the prophylaxis of NEC in premature neonates.
FMT preparation will be prepared specifically for this study by the Human Biome Institute (HBI), with which a scientific collaboration has been established for this experiment. The donors of the material from which the FMT will be prepared will be women in the third trimester of pregnancy who will consent to the collection the material from them, and who will pass a detailed health questionnaire and medical and additional examinations in accordance with the donor qualification protocol according to international recommendations in the method and the procedure developed by the HBI (Human Biome Institute).
During this interventional, prospective, double arm, open-label study, the investigators will collect the information about the safety of FMT in the prophylaxis of NEC.
The project protocol is based on the intervention (fecal microbiota transplantation; FMT) as a deep rectal infusion, via Foley's catheter inserted under ultrasound control. The procedure will be conducted twice, 6 hours apart, between 3 and 6 days after birth and/or up to 14 days, to participants who have transient contraindications to FMT or to participants who will be referred for treatment at our facility from an outpatient facility.
After the procedure, the participants will be closely monitored for adverse reactions up to the discharge from the hospital.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 40 is below the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 5, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Preterm infants hospitalized in the intensive care unit and neonatal pathology unit during the study period
1. Born naturally or by cesarean section between:
Exclusion Criteria:
Temporary exclusion criteria
If at least 1 of the following occurs before FMT and up to 14 days of age:
Intolerance to oral feeding, based on the assessment of the qualifying physician on the day of FMT:
Suspected NEC:
Clinical signs of infection or significantly elevated inflammatory parameters - If at least one of the following clinical signs and/or more than 1 laboratory sign occurs:
Elevated inflammatory parameters:
PCT (procalcitonin) level (>72 HoL) > 0,5-1ng/ml (at the norm up to > 0,5-1ng/ml); count \< 50 thousand, coagulopathy positive cultures of normally sterile body fluids
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Fecal Microbiota Transplantation
Matched Patients without intervention
Procedure: Fecal Microbiota Transplantation Fecal Microbiota as a suspension obtained from healthy unrelated donor (woman in 3rd trimester of pregnancy) introduced two times per treatment: * as a deep rectal infusion, via Foley's catheter inserted under ultrasound control, twice 6 hours apart, between 3 and 6 days after birth and/or up to 14 days * Other Names: MBiotix HBI
Adverse reactions monitoring
The safety of the procedure will be assessed on the basis of: 1. number of episodes of oral feeding intolerance, diarrhoea, blood/mucus/pus in stools 2. appearance of symptoms of infection or significant change in vital parameters (heart rate ECG and oxygen saturation - continuous measurement, blood pressure 4x/day, temperature, possibly HERO) 3. number of developed NEC 4. assessment of blood flow in the upper mesenteric artery by ultrasound 5. observation of other symptoms - convulsions, unbridled crying, anxiety 6. the number of positive blood cultures, the percentage of antibiotic therapy 7. number of serious side effects - death, serious threat to health and/or life and/or deterioration of health 8. Length of hospitalization
Time frame: Up to the discharge from the hospital (approximately from 2 weeks to 3 months)
Plan to share: No
Started Feb 2026 (actual). Primary completion is estimated for Oct 2027, 20 months after the start.
Of 33 interventional studies with no phase under Enterocolitis, Necrotizing, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's planned 20 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start May 2024 → Feb 2026, primary completion Jan 2025 → Oct 2027 and completion Jan 2025 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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