Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
Fecal Microbiota Transplantation FMT as a Prophylaxis of Necrotizing Enterocolitis NEC - Clinical Study
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1000 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 Foleys catheter inserted under ultrasound control The procedure will be conducted twice 6 hours apart between 3 and 6 days after birth andor 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
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 Foleys catheter inserted under ultrasound control The procedure will be conducted twice 6 hours apart between 3 and 6 days after birth andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None