Necrotizing Enterocolitis
Conditions
Keywords
Enterocolitis, Necrotizing; Fecal Microbiota Transplantation; Necrotizing Enterocolitis prophylaxis
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.
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.
Interventions
DRUGFecal 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
Sponsors
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
single group, open label, observational study with intervention (FMT)
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 36 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions monitoring | 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 |
Countries
Poland
Contacts
Primary ContactMarek Wolski, MD, PhD
Backup ContactEwa A Begańska, MD
Outcome results
None listed