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

Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Newborn Infants
• Intervention / Treatment: Other: Placebo; Dietary supplement: Synbiotic Supplement

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paula Tähtinen, MD, PhD; Phone Number: +358-2-3130746; Email: paula.tahtinen@utu.fi

Study Locations

• Finland
  • Valitse maakunta.
    • Turku, Valitse maakunta., Finland, 20780
      • Recruiting
      • Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku
      • Principal Investigator: Erika Isolauri, MD, PhD
      • Contact: Paula Tähtinen, MD, PhD; Phone Number: +358-2-3130746; Email: paula.tahtinen@utu.fi
      • Contact: Email: paula.tahtinen@utu.fi
      • Sub-Investigator: Paula Tähtinen, MD, PhD
      • Sub-Investigator: Tuuli Vuorisalo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Maltodextrin
Active Comparator: Synbiotic; Bifidobacterium bifidum and human milk oligosaccharides (HMOs)	Dietary supplement: Synbiotic Supplement; Bifidobacterium bifidum and human milk oligosaccharides (HMOs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Child's height at the age of 6, 12, 18, and 24 months	From enrollment to 24 months of age
Weight	Child's weight at the age of 6, 12, 18, and 24 months	From enrollment to 24 months of age
Growth velocity	Child's growth velocity at 2-3 months of age	From enrollment to 3 months of age
Child's microbiome	The function and composition of the child's gut, nasal, and mouth microbiome at the age of 2, 6, 12, 18, and 24 months	From enrollment to 24 months of age
Mother's microbiome	The function and composition of the mother's gut, nasal, and mouth microbiome when the child is 2 and 6 months of age	From enrollment to 6 months after giving birth
Breast milk microbiome	The composition of breast milk's microbiome when the child is 2 and 6 months of age	From enrollment to 6 months of age
Hormonal levels	Child's hormonal levels (testosterone, sex hormone-binding globulin, luteinizing hormone and follicle-stimulating hormone) at birth and at the age of 2 and 6 months	From enrollment to 6 months of age
Inflammatory markers	Systemic inflammation markers (cytokines, C-reactive protein, soluble urokinase-type plasminogen activator receptor and haptoglobulin) at birth and at the age of 2 and 6 months	From enrollment to 6 months of age
Respiratory tract infections	Respiratory tract infections by the age of 24 months	From enrollment to 24 months of age

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Lallemand Health Solutions

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 27, 2025
• First Submitted That Met QC Criteria: May 7, 2025
• First Posted (Actual): May 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: obesity; probiotics; microbiome; newborn; microbiota; antibiotics; infectious diseases; human milk oligosaccharides
• Other Study ID Numbers: T1927_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD may be shared for research purposes upon special request to the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No