Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study

NCT06333405 | Not Yet Recruiting

• 1 other identifier: FMTNEC/01/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Necrotizing Enterocolitis

Keywords

Enterocolitis, Necrotizing; Fecal Microbiota Transplantation; Necrotizing Enterocolitis prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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

  Up to the discharge from the hospital (approximately from 2 weeks to 3 months)

Study Arms (1)

Experimental: Fecal Microbiota Transplantation

EXPERIMENTAL

Drug: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation DRUG

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

Experimental: Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 24 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants hospitalized in the intensive care unit and neonatal pathology unit during the study period
• \. Born naturally or by cesarean section between:
• /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

You may not qualify if:

• 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
• 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:
• 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
• Labolatory signs of infection:
• Elevated inflammatory parameters:

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw, Pediatric Surgery Clinic

Warsaw, Mazovian Voivodeship, 02-097, Poland

Location

Related Publications (6)

• 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.

  PMID: 30414693 BACKGROUND

• Liu 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.

  PMID: 32234317 BACKGROUND

• Li 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.

  PMID: 28323128 BACKGROUND

• Hui 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.

  PMID: 35680942 BACKGROUND

• Korpela 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.

  PMID: 33007265 BACKGROUND

• Ma 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.

  PMID: 34915267 BACKGROUND

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Enterocolitis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Marek Wolski, MD, PhD

CONTACT

665578922; marek.wolski@wum.edu.pl

Ewa A Begańska, MD

CONTACT

692542543; ewa.bieganska@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single group, open label, observational study with intervention (FMT)

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: May 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)