Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section (GOLF-CS)

May 2, 2025 updated by: HiPP GmbH & Co. Vertrieb KG

Evaluation of the Effect of an Infant Formula Containing Synbiotics on the Composition of the Gut Microbiota in Infants Born Via Caesarean Section

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Since caesarean section (CS)-born infants show dysbiotic microbial colonization during the first weeks of life, exclusive breastfeeding is the feeding mode of choice for these infants. However, since CS births are often associated with breast-feeding difficulties, it is of importance to feed an microbiota-supportive infant formula. This study is designed to investigate whether an infant formula supplemented with synbiotics positively affects the microbial composition, gastrointestinal characteristics and the proper function of the immune system in CS-born infants, compared to feeding a standard infant formula without synbiotics in either CS- and vaginal-born infants during the first 6 months of life. The growth of the infants as well as tolerance, infectious diseases and allergies will also be assessed. In order to investigate the effect of different birth modes and feeding conditions on the microbiota, the study population will include healthy term infants, born either by CS or by VD, additional groups receive human milk or formula with prebiotics only. Additionally, if the parents agree, their infant will be followed up until 24 months of age with a special focus on the prevention of infections and allergies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
486

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Bulgaria
      • Pleven, Bulgaria
        • University multiprofile hospital for active treatment "Dr. Georgi Stranski" EAD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 days to 6 days (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Standard Infant Formula with synbiotics (CS-born)
CS born infants, randomized to receive infant formula with synbiotics
Other: Intervention Group 1: Infant Formula with synbiotics
Infants will receive infant formula during the first 6 months of life
Experimental: Standard Infant Formula with prebiotics (CS-born)
CS born infants, randomized to receive infant formula with prebiotics
Other: Intervention Group 2: Infant Formula with prebiotics
Infants will receive infant formula during the first 6 months of life
Active Comparator: Control Group 1: Standard Infant Formula (CS-born)
CS born infants, randomized to receive standard infant formula without synbiotics
Other: Control Group 1 and 2: Infant Formula without synbiotics
Infants will receive infant formula during the first 6 months of life
Active Comparator: Control Group 2 : Standard Infant Formula (VD-born)
VD born infants, receiving standard infant formula without synbiotics (self-selected for formula-feeding = non-randomized)
Other: Control Group 1 and 2: Infant Formula without synbiotics
Infants will receive infant formula during the first 6 months of life
No Intervention: Reference Group 1: Breastfed (CS-born)
CS-born infants, receiving exclusive breast-feeding with mother's own breast milk (non-randomized)
No Intervention: Reference Group 2: Breastfed (VD-born)
VD-born infants, receiving exclusive breast-feeding with mother's own breast milk (non-randomized)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 6 months duration
6 months duration

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HiPP GmbH & Co. Vertrieb KG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD, Pleven, Bulgaria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Victoria Assoc. Prof. Dr. Atanasova, MD, PhD, "Dr. Georgi Stranski" EAD, 91 "Vladimir Vazov" Str., 5809 Pleven, Bulgaria

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 510646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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