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

March 20, 2024 updated by: Medical University of Warsaw

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Mazovian Voivodeship
      • Warsaw, Mazovian Voivodeship, Poland, 02-097
        • Medical University of Warsaw, Pediatric Surgery Clinic
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 exclusion criteria

If at least 1 of the following occurs before FMT and up to 14 days of age:

  1. 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

  2. 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)
  3. Antibiotic therapy during planned FMT treatment

  4. 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:

    • 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 >0.05mg/l (at the norm up to <0.05-1mg/l),

    • PCT (>72 HoL) > 0,5-1ng/ml (at the norm up to > 0,5-1ng/ml); Platelet count < 50K, coagulopathy positive cultures of normally sterile body fluids

      • Radiological evidence of infection, including systemic e. g. gallbladder bed swelling, unexplained sudden echocardiographic pulmonary hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Fecal Microbiota Transplantation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to the discharge from the hospital (approximately from 2 weeks to 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMTNEC/01/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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