Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section
GOLF-CS
Evaluation of the Effect of an Infant Formula Containing Synbiotics on the Composition of the Gut Microbiota in Infants Born Via Caesarean Section
1 other identifier
interventional
486
1 country
1
Brief Summary
A multi-centre, randomized, parallel-group, double-blind, controlled, exploratory clinical trial is conducted to assess the positive effect of feeding a formula containing synbiotics (pre- and probiotics) on the composition of the gut microbiota in caesarean section (CS) born healthy term infants within the first 6 months of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2021
CompletedFirst Posted
Study publicly available on registry
August 5, 2021
CompletedStudy Start
First participant enrolled
September 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2024
CompletedMay 6, 2025
May 1, 2025
1.2 years
July 28, 2021
May 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment whether an infant formula containing synbiotics positively affects the composition of the gut microbiota in CS-born infants compared to a standard formula (without synbiotics) or breast-feeding within the first 6 months of life
6 months duration
Study Arms (6)
Standard Infant Formula with synbiotics (CS-born)
EXPERIMENTALCS born infants, randomized to receive infant formula with synbiotics
Standard Infant Formula with prebiotics (CS-born)
EXPERIMENTALCS born infants, randomized to receive infant formula with prebiotics
Control Group 1: Standard Infant Formula (CS-born)
ACTIVE COMPARATORCS born infants, randomized to receive standard infant formula without synbiotics
Control Group 2 : Standard Infant Formula (VD-born)
ACTIVE COMPARATORVD born infants, receiving standard infant formula without synbiotics (self-selected for formula-feeding = non-randomized)
Reference Group 1: Breastfed (CS-born)
NO INTERVENTIONCS-born infants, receiving exclusive breast-feeding with mother's own breast milk (non-randomized)
Reference Group 2: Breastfed (VD-born)
NO INTERVENTIONVD-born infants, receiving exclusive breast-feeding with mother's own breast milk (non-randomized)
Interventions
Infants will receive infant formula during the first 6 months of life
Infants will receive infant formula during the first 6 months of life
Infants will receive infant formula during the first 6 months of life
Eligibility Criteria
You may qualify if:
- Healthy term infants
- Female or male gender
- Gestational age ≥37 weeks, \<42 weeks
- Singleton, born by caesarean section or vaginally born
- Birth weight between ≥2500g and ≤4200g with a regular weight gain without any signs of developmental delays or growth disorders according to investigator opinion
- Uncomplicated early course of neonatal period
- Age at enrolment: 5 +/-1 days of life
- Infants whose parent(s)/ legal authorized representatives (LAR(s)) have reached the legal age of majority in Bulgaria
- Infants whose parent(s)/ LAR(s) are capable of and willing to comply with the protocol and have signed the informed consent form in accordance with legal requirements
- At least one of the legal representatives is affiliated to a health security/insurance or equally
- Infants whose parent(s)/ LAR(s) are willing to comply with the feeding regimen during the intervention period. Infant's parent(s)/ LAR(s) will decide which feeding regimen will be used (infant formula or breast milk)
- Parents/ LARs who agree to not use any sort of other formula than provided during the study
You may not qualify if:
- Intensive care prior to or at Baseline Visit
- UV-treatment of jaundice and clinical significant jaundice prior to Baseline Visit (according to investigator opinion)
- Known immune deficiency
- Serious acquired or congenital diseases, chromosomal anomalies (if known)
- Serious pre-natal and/or serious post-natal disease before enrolment (per investigator's medical diagnosis)
- Infants or mothers under antibiotic treatment before Baseline Visit (only for vaginally born and breastfed infants) or at Baseline Visit (all groups)
- Infants requiring infant formula intake other than those specified in the protocol (formula for special medical purposes (FSMP), formula with hydrolyzed protein (allergy risk)
- Infant's supplementation or formula intake, which contains probiotics, prebiotics, dietary fibres or synbiotics before and during study
- Feeding difficulties or formula intolerance according to investigator's opinion
- Currently participating or having participated in another clinical trial since birth
- Reason to presume that the infant's parent(s)/LAR(s) are unable to meet the study plan requirements, such as drug/alcohol abuse, psychological or linguistic incapability, chronic or mental diseases
- Infants born to mothers with medical conditions that require prescription medication (coagulation abnormalities, if acetylsalicylic acid was not stopped at 35 weeks GA according to guidelines, mothers treated with Methyldopa, ACE inhibitors, breastfeeding mothers treated with L-thyroxine, diabetic mothers, epileptic mothers)
- Any smoking, drug or alcohol intake by the mother during the last two trimesters of pregnancy
- Mother's weight gain \>18 kg during pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University multiprofile hospital for active treatment "Dr. Georgi Stranski" EAD
Pleven, Bulgaria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Assoc. Prof. Dr. Atanasova, MD, PhD
"Dr. Georgi Stranski" EAD, 91 "Vladimir Vazov" Str., 5809 Pleven, Bulgaria
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
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2021
First Posted
August 5, 2021
Study Start
September 23, 2021
Primary Completion
November 29, 2022
Study Completion
July 7, 2024
Last Updated
May 6, 2025
Record last verified: 2025-05