NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT

NCT06282952 | Not Yet Recruiting

• 1 other identifier: 198/2023
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section to obese mothers and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:

• Could fecal transplant be used improve gut microbiota and prevent overweight or obesity.
• Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.

Conditions

Fecal Microbiota Transplantation; Cesarean Section; Overweight and Obesity

Keywords

Fecal Microbiota Transplantation; Cesarean Section; Overweight and Obesity

Outcome Measures

Primary Outcomes (5)

• Microbial composition profiles in fecal sample

  The difference in microbial composition profiles in fecal sample between the infants in different study groups, specifically diversity and relative abundances of different bacteria phyla and species.

  Until 12 months of age

• Height in centimeters

  The difference in growth in height between the infants in different study groups

  3 years of age

• Height z-score

  The difference in growth in height between the infants in different study groups

  3 years of age

• Weight in kilograms

  The difference in growth in weight in infants the infants in different study groups

  3 years of age

• Weight-for-length (%)

  The difference in growth in weight in infants the infants in different study groups

  3 years of age

Secondary Outcomes (1)

• The source of colonization by exclusively shared genes (ESGs)

  3 month of age

Study Arms (3)

Fecal microbiota transplant from biobank

EXPERIMENTAL

The newborns receive fecal microbiota transplant from their own mother (50 newborns).

Dietary Supplement: Fecal transplant

Fecal microbiota transplant from own mother

ACTIVE COMPARATOR

Newborns receive fecal microbiota transplant from normal weight, healthy female donor from the Microbiome Biobank (50 newborns).

Dietary Supplement: Fecal transplant

The observational cohort

NO INTERVENTION

If mother has Group B streptococcus (GBS) colonization or other infectious, and microbiota transplant cannot be given or if mother will have non-elective-CS and the microbiome transplant is not available, the mother is included in the observational cohort, which is "open" (not blinded).

Interventions

Fecal transplant DIETARY_SUPPLEMENT

At delivery, the fecal transplant is thawed and 0.5 mL representing 3.5 mg of the mother's or donors' fecal sample is dissolved in 5 mL of the mother's own milk or when not available pasteurized bank milk. The sample is given orally to newborn infants as soon as possible but not later than 6 h of delivery and not later than two hours after defrosting.

Fecal microbiota transplant from biobank; Fecal microbiota transplant from own mother

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women age 18-49 years with obesity (prepregnancy BMI ≥ 30 kg/m2) scheduled for elective CS at term, are recruited at 36 weeks of gestation during a visit for the assessment of mode of delivery at Oulu university Hospital, Oulu, Finland.

You may not qualify if:

• Use of regular immunosuppressive biological medication, immunodeficiency disorder of mother or other first degree family member of the unborn baby, known or suspected fetal major congenital abnormality, travelling abroad outside European countries or United States within the last three months and antibiotic treatment within 3 months of delivery (excluding the prophylactic cefuroxime (or other in case of allergy) given prior to the elective CS).

Sponsors & Collaborators

• Oulu University Hospital: lead
• University of Oulu: collaborator
• University of Turku: collaborator
• Turku University Hospital: collaborator
• University of Helsinki: collaborator
• Academy of Finland: collaborator
• Biocenter Oulu: collaborator

Related Publications (24)

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MeSH Terms

Conditions

Overweight; Obesity

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Terhi Tapiainen, Professor

  Oulu Univeristy Hospital

  PRINCIPAL INVESTIGATOR

• Marika Paalanne, MD, PhD

  Oulu Univeristy Hospital

  STUDY DIRECTOR

Central Study Contacts

Marika Paalanne, MD, PhD

CONTACT

+358 50 579 4646; marika.paalanne@oulu.fi

Terhi Tapiainen, Professor

CONTACT

+358505794420; terhi.tapiainen@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The research statistician performs the computer-generated randomization. The study nurse prepares the fecal transplant according to the randomization. Study participants or investigators are not aware of study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: The eligible women are randomized into two groups in which their newborns receive either fecal microbiota transplant from 1) their own mother (50 newborns) or 2) the Microbiome Biobank (50 newborns). The randomization 1:1 is done in blocks of 4 mothers. The study is double blinded. If mother has Group B streptococcus colonization or other infectious disease described in table 1, and microbiota transplant cannot be given or if mother will have non-elective-CS and the microbiome transplant is not available, the mother is included in 3) the observational cohort, which is "open" (not blinded).

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: February 28, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share