Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation

NCT06974994 | Recruiting

• 1 other identifier: T1927_2023
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.

Conditions

Healthy Newborn Infants

Keywords

antibiotics; human milk oligosaccharides; probiotics; newborn; microbiome; microbiota; obesity; infectious diseases

Outcome Measures

Primary Outcomes (1)

• BMI at 24 months of age

  Child's body mass index (BMI) at the age of 24 months

  From enrollment to 24 months of age

Secondary Outcomes (9)

• Height

  From enrollment to 24 months of age

• Weight

  From enrollment to 24 months of age

• Growth velocity

  From enrollment to 3 months of age

• Child's microbiome

  From enrollment to 24 months of age

• Mother's microbiome

  From enrollment to 6 months after giving birth

Study Arms (2)

Synbiotic

ACTIVE COMPARATOR

Bifidobacterium bifidum and human milk oligosaccharides (HMOs)

Dietary Supplement: Synbiotic Supplement

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Synbiotic Supplement DIETARY_SUPPLEMENT

Bifidobacterium bifidum and human milk oligosaccharides (HMOs)

Synbiotic

Placebo OTHER

Maltodextrin

Placebo

Eligibility Criteria

• Age: 2 Hours+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.

You may not qualify if:

• Chorioamnionitis
• Pre-eclampsia and hepatogestosis
• Suspected malformation or serious condition of the foetus and neonates
• Serious infection or other conditions not permitting breast milk feeding

Sponsors & Collaborators

• Turku University Hospital: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku

Turku, Valitse Maakunta., 20780, Finland

RECRUITING

MeSH Terms

Conditions

Obesity; Communicable Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Disease Attributes; Pathologic Processes

Central Study Contacts

Paula Tähtinen, MD, PhD

CONTACT

+358-2-3130746; paula.tahtinen@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Paediatrics

Model Details: Randomized, placebo-controlled trial

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 16, 2025
• Study Start: May 8, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

FI (1)