NCT06333405

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 24 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

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.

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, single arm, open-label, observational 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.

Conditions

• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DRUG	Fecal Microbiota Transplantation	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

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: Poland