Necrotizing Enterocolitis (NEC)NCT06333405
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
A study testing Fecal Microbiota Transplantation in people with Necrotizing Enterocolitis (NEC) and Necrotizing Enterocolitis of Newborn, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 36 weeks
- Conditions the study is for
- Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants hospitalized in the intensive care unit and neonatal pathology unit during the study period
- 1. Born naturally or by cesarean section between:
- 24 0/7 and 36 6/7 weeks of gestation
- 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
- Newborns born in and out of hospital
- Parental consent to participate in the study
Who cannot join
- 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).
- Gastrointestinal perforation
- Food allergy with anaphylactic shock
- 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:
Show all 20Show fewer
- 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
- 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)
- Antibiotic therapy during planned FMT treatment
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw, Pediatric Surgery Clinic
Warsaw, Mazovian Voivodeship, 02-097
Marek Wolski, MD, PhD, 665578922 ext. +48, marek.wolski@wum.edu.pl
Ewa A. Biegańska, MD, 692542543 ext. +48, ewa.bieganska@wum.edu.pl
About this study
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
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.
Read the detailed description
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.
- Being tested
- Fecal Microbiota Transplantation
- Keywords
- fecal microbiota transplantation, necrotizing enterocolitis prophylaxis
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Fecal Microbiota Transplantation | Experimental | Not described Receives: Drug: Fecal Microbiota Transplantation |
| Control | No intervention | Matched Patients without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions monitoring
The safety of the procedure will be assessed on the basis of:
- number of episodes of oral feeding intolerance, diarrhoea, blood/mucus/pus in stools
- 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)
- number of developed NEC
- assessment of blood flow in the upper mesenteric artery by ultrasound
- observation of other symptoms - convulsions, unbridled crying, anxiety
- the number of positive blood cultures, the percentage of antibiotic therapy
- number of serious side effects - death, serious threat to health and/or life and/or deterioration of health
- Length of hospitalization
Measured: Up to the discharge from the hospital (approximately from 2 weeks to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Feb 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Necrotizing Enterocolitis (NEC)Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single group, open label, observational study with intervention (FMT)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333405
- Sponsor's protocol ID
- FMTNEC/01/2024
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prado C, Michels M, Avila P, Burger H, Milioli MVM, Dal-Pizzol F. The protective effects of fecal microbiota transplantation in an experimental model of necrotizing enterocolitis. J Pediatr Surg. 2019 Aug;54(8):1578-1583. doi: 10.1016/j.jpedsurg.2018.10.045. Epub 2018 Oct 22.
PubMed 30414693Liu J, Miyake H, Zhu H, Li B, Alganabi M, Lee C, Pierro A. Fecal microbiota transplantation by enema reduces intestinal injury in experimental necrotizing enterocolitis. J Pediatr Surg. 2020 Jun;55(6):1094-1098. doi: 10.1016/j.jpedsurg.2020.02.035. Epub 2020 Feb 26.
PubMed 32234317Li X, Li X, Shang Q, Gao Z, Hao F, Guo H, Guo C. Fecal microbiota transplantation (FMT) could reverse the severity of experimental necrotizing enterocolitis (NEC) via oxidative stress modulation. Free Radic Biol Med. 2017 Jul;108:32-43. doi: 10.1016/j.freeradbiomed.2017.03.011. Epub 2017 Mar 16.
PubMed 28323128Hui Y, Vestergaard G, Deng L, Kot WP, Thymann T, Brunse A, Nielsen DS. Donor-dependent fecal microbiota transplantation efficacy against necrotizing enterocolitis in preterm pigs. NPJ Biofilms Microbiomes. 2022 Jun 9;8(1):48. doi: 10.1038/s41522-022-00310-2.
PubMed 35680942Korpela K, Helve O, Kolho KL, Saisto T, Skogberg K, Dikareva E, Stefanovic V, Salonen A, Andersson S, de Vos WM. Maternal Fecal Microbiota Transplantation in Cesarean-Born Infants Rapidly Restores Normal Gut Microbial Development: A Proof-of-Concept Study. Cell. 2020 Oct 15;183(2):324-334.e5. doi: 10.1016/j.cell.2020.08.047. Epub 2020 Oct 1.
PubMed 33007265Ma X, Xu T, Qian M, Zhang Y, Yang Z, Han X. Faecal microbiota transplantation alleviates early-life antibiotic-induced gut microbiota dysbiosis and mucosa injuries in a neonatal piglet model. Microbiol Res. 2022 Feb;255:126942. doi: 10.1016/j.micres.2021.126942. Epub 2021 Dec 10.
PubMed 34915267Bieganska EA, Wolski M, Zarlenga M, Bilinski J, Kosinski P. Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC)-Protocol for a Safety Study. Pharmaceuticals (Basel). 2026 Mar 9;19(3):437. doi: 10.3390/ph19030437.
PubMed 41901284
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06333405
- Acronym / sponsor ID
- FMTNEC/01/2024
- Keywords
- fecal microbiota transplantation, necrotizing enterocolitis prophylaxis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single group, open label, observational study with intervention (FMT)
| Arm | Type | Receives |
|---|---|---|
| Experimental: Fecal Microbiota Transplantation | Experimental | Drug: Fecal Microbiota Transplantation |
| Control | No intervention | –Matched Patients without intervention |
Who may qualify
- Ages
- 24 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preterm infants hospitalized in the intensive care unit and neonatal pathology unit during the study period
Key exclusion criteria (20 listed)
- 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).
- Gastrointestinal perforation
- Food allergy with anaphylactic shock
- Participation in another clinical trial that may affect the final outcome of the planned intervention
- Temporary exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationProcedure: 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 | Drug | Experimental: Fecal Microbiota Transplantation |
Primary outcome
Adverse reactions monitoring
Time frame: Up to the discharge from the hospital (approximately from 2 weeks to 3 months)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 30414693Prado C, Michels M, Avila P, Burger H, Milioli MVM, Dal-Pizzol F. The protective effects of fecal microbiota transplantation in an experimental model of necrotizing enterocolitis. J Pediatr Surg. 2019 Aug;54(8):1578-1583. doi: 10.1016/j.jpedsurg.2018.10.045. Epub 2018 Oct 22.
- Background: PubMed 32234317Liu J, Miyake H, Zhu H, Li B, Alganabi M, Lee C, Pierro A. Fecal microbiota transplantation by enema reduces intestinal injury in experimental necrotizing enterocolitis. J Pediatr Surg. 2020 Jun;55(6):1094-1098. doi: 10.1016/j.jpedsurg.2020.02.035. Epub 2020 Feb 26.
- Background: PubMed 28323128Li X, Li X, Shang Q, Gao Z, Hao F, Guo H, Guo C. Fecal microbiota transplantation (FMT) could reverse the severity of experimental necrotizing enterocolitis (NEC) via oxidative stress modulation. Free Radic Biol Med. 2017 Jul;108:32-43. doi: 10.1016/j.freeradbiomed.2017.03.011. Epub 2017 Mar 16.
- Background: PubMed 35680942Hui Y, Vestergaard G, Deng L, Kot WP, Thymann T, Brunse A, Nielsen DS. Donor-dependent fecal microbiota transplantation efficacy against necrotizing enterocolitis in preterm pigs. NPJ Biofilms Microbiomes. 2022 Jun 9;8(1):48. doi: 10.1038/s41522-022-00310-2.
- Background: PubMed 33007265Korpela K, Helve O, Kolho KL, Saisto T, Skogberg K, Dikareva E, Stefanovic V, Salonen A, Andersson S, de Vos WM. Maternal Fecal Microbiota Transplantation in Cesarean-Born Infants Rapidly Restores Normal Gut Microbial Development: A Proof-of-Concept Study. Cell. 2020 Oct 15;183(2):324-334.e5. doi: 10.1016/j.cell.2020.08.047. Epub 2020 Oct 1.
- Background: PubMed 34915267Ma X, Xu T, Qian M, Zhang Y, Yang Z, Han X. Faecal microbiota transplantation alleviates early-life antibiotic-induced gut microbiota dysbiosis and mucosa injuries in a neonatal piglet model. Microbiol Res. 2022 Feb;255:126942. doi: 10.1016/j.micres.2021.126942. Epub 2021 Dec 10.
- Derived from this study: PubMed 41901284Bieganska EA, Wolski M, Zarlenga M, Bilinski J, Kosinski P. Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC)-Protocol for a Safety Study. Pharmaceuticals (Basel). 2026 Mar 9;19(3):437. doi: 10.3390/ph19030437.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation in people with Necrotizing Enterocolitis (NEC) and Necrotizing Enterocolitis of Newborn, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Wolski, MD, PhD (665578922 ext. +48, marek.wolski@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reactions monitoring (time frame: Up to the discharge from the hospital (approximately from 2 weeks to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333405, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.