FMT as a preventive measure for NEC in premature infants
Official title: Evaluation of the Safety of Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) in a Group of Newborns at Increased Risk for the Disease
Run by Medical University of Warsaw · NCT06333405 · Data updated 2026-11-12
This study tests whether giving fecal microbiota transplantation to preterm babies can safely prevent necrotizing enterocolitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 24 Weeks to 36 Weeks |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw, Mazovian Voivodeship) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | October 30, 2027 |
| Study ends | October 30, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06333405 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Premature neonates admitted to the NICU who are 24 0/7 to 36 6/7 weeks gestational age, have completed antibiotic therapy at least 24 hours prior, and whose parents consent to participate.
✕Probably not a fit
Some infants may not benefit and could experience adverse effects or no effect on NEC risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional, prospective study evaluates the safety of fecal microbiota transplantation (FMT) as a prophylactic measure to prevent NEC in premature neonates. It uses a two-arm, open-label design to monitor adverse events and side effects in enrolled infants after FMT administration. FMT material is prepared under a defined donor protocol by the Human Biome Institute and given to eligible preterm infants in the neonatal intensive care setting. The trial focuses on safety signals and tolerability rather than efficacy outcomes at this stage. Lead oversight is provided by the Medical University of Warsaw, with the Pediatric Surgery Clinic as the participating site.
Why it matters
Potential benefit: If successful, the approach could offer a new preventive option to reduce NEC risk in preterm infants.
How similar studies have gone: Earlier experimental models and limited clinical work have shown promising safety signals for FMT in NEC prevention, but robust clinical evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Preterm infants hospitalized in the intensive care unit and neonatal pathology unit during the study period
1. 1\. Born naturally or by cesarean section between:
1. 24 0/7 and 36 6/7 weeks of gestation
2. Age \>48 hours, a minimum of 24 hours after completion of antibiotic therapy and up to day 14 for newborns \<35 weeks of gestation and up to day 6 for newborns \>35 weeks of gestation
3. Newborns born in and out of hospital
4. Parental consent to participate in the study
Exclusion Criteria:
1. Occurrence of congenital defects of the gastrointestinal tract preventing proper intestinal passage (esophageal atresia, duodenal atresia, rectal atresia, tracheo-esophageal fistulas) and occurrence of genetic diseases diagnosed prenatally or at birth (trisomies, other genetic syndromes).
2. Gastrointestinal perforation
3. Food allergy with anaphylactic shock
4. Participation in another clinical trial that may affect the final outcome of the planned intervention
Temporary exclusion criteria
If at least 1 of the following occurs before FMT and up to 14 days of age:
1. Intolerance to oral feeding, based on the assessment of the qualifying physician on the day of FMT:
* painful bloating in the abdomen and/or visible bowel loops, blood in the stools,
* delayed gastric emptying: two consecutive episodes exceeding \>50% of the volume of the previous serving, 2 or more consecutive episodes of retention / vomiting / regurgitation of biliary contents / duodenal contents/ blood - episodes not related to anxiety, delayed bowel movements, possibility of swallowing blood during childbirth or from damaged nipples, abnormality of the positioning of gastric tube, bleeding from the nose
2. Suspected NEC:
* clinical signs typical for NEC - Bell criteria, redness/bruising of the anterior abdominal wall, palpable abdominal resistance, hypotension; laboratory signs: hyponatraemia, metabolic acidosis, thrombocytopenia, increased inflammation parameters)
3. Antibiotic therapy during planned FMT treatment
4. 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:
• Clinical signs of infection: Hemodynamic instability (hypotension, tachycardia, peripheral circulatory disturbances (by age standards), thermoregulatory disturbances, fever\>38 deg C, hypothermia \<36 deg C) Apathy, lethargy, convulsions Apneas, deterioration of respiratory capacity
• Laboratory signs of infection:
Elevated inflammatory parameters:
* leukocytosis \<5 i \>30x109/L up to 48 hours of life (HoL) and \<5 i \>20x109/L \>48 hours of life, the band neutrophil : total neutrophil (I:T) ratio of \>0.2 for \>34 weeks of gestation and \>0,16 for \<34 weeks of gestation
* CRP (C-reactive protein) level \>0.05mg/l (at the norm up to \<0.05-1mg/l),
* PCT (procalcitonin) level (\>72 HoL) \> 0,5-1ng/ml (at the norm up to \> 0,5-1ng/ml); Platelet count \< 50 thousand, coagulopathy positive cultures of normally sterile body fluids
* Radiological evidence of infection, including systemic e. g. gallbladder bed swelling, unexplained sudden echocardiographic pulmonary hypertension
Where it's running
-
Medical University of Warsaw, Pediatric Surgery Clinic
Warsaw, Mazovian Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Marek Wolski, MD, PhD
- Email: marek.wolski@wum.edu.pl
- Phone: 665578922
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Amniotic fluid and the extremely preterm baby's gut
We will see if amniotic fluid from extremely preterm births (24+0 to 27+6 weeks) shows changes that relate to gut problems such as necrotizing enterocolitis or sepsis in very preterm infants.
-
Effect of donor milk or formula and fortification strategies on outcomes in very preterm infants
In very preterm babies, the study tests whether supplementing the infant's mother's milk with pasteurized donor milk or preterm formula, and using routine versus selective fortification, can improve survival without NEC and support development.
-
Using AI to predict necrotizing enterocolitis in premature babies through stool analysis
This study is trying to see if using AI to analyze stool samples from premature babies can help predict who is at risk for necrotizing enterocolitis, so doctors can take steps to prevent it.
-
NETs — protective or harmful in newborn inflammation and infection?
We will test how immune cells from very premature babies at risk for NEC make proteins when exposed to a substance called PAF, comparing them with cells from healthy term infants and adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.