Gut MicrobiotaGOLF-CSNCT04991792
Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section
A study testing Intervention Group 1: Infant Formula with synbiotics and Intervention Group 2: Infant Formula with prebiotics in people with Gut Microbiota, run by HiPP GmbH & Co. Vertrieb KG at 1 site in Bulgaria.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 6 daysHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- Intervention Group 1: Infant Formula with synbiotics and Intervention Group 2: Infant Formula with prebiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 1 siteBulgaria
- Study dates
- 23 Sep 2021to 7 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
University multiprofile hospital for active treatment "Dr. Georgi Stranski" EAD
Pleven
About this study
Official title: 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.
Read the 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.
- Conditions
- Gut Microbiota
- Being tested
- Intervention Group 1: Infant Formula with synbiotics, Intervention Group 2: Infant Formula with prebiotics, Control Group 1 and 2: Infant Formula without synbiotics
- Keywords
- Caesarean Section; Microbiota; Infant Formula; Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group 1: Infant Formula with synbioticsOther
Infants will receive infant formula during the first 6 months of life
Intervention Group 2: Infant Formula with prebioticsOther
Infants will receive infant formula during the first 6 months of life
Control Group 1 and 2: Infant Formula without synbioticsOther
Infants will receive infant formula during the first 6 months of life
| Study group | Role | What they receive |
|---|---|---|
| Standard Infant Formula with synbiotics (CS-born) | Experimental | CS born infants, randomized to receive infant formula with synbiotics Receives: Other: Intervention Group 1: Infant Formula with synbiotics |
| Standard Infant Formula with prebiotics (CS-born) | Experimental | CS born infants, randomized to receive infant formula with prebiotics Receives: Other: Intervention Group 2: Infant Formula with prebiotics |
| Control Group 1: Standard Infant Formula (CS-born) | Active comparator | CS born infants, randomized to receive standard infant formula without synbiotics Receives: Other: Control Group 1 and 2: Infant Formula without synbiotics |
| Control Group 2 : Standard Infant Formula (VD-born) | Active comparator | VD born infants, receiving standard infant formula without synbiotics (self-selected for formula-feeding = non-randomized) Receives: Other: Control Group 1 and 2: Infant Formula without synbiotics |
| Reference Group 1: Breastfed (CS-born) | No intervention | CS-born infants, receiving exclusive breast-feeding with mother's own breast milk (non-randomized) |
| Reference Group 2: Breastfed (VD-born) | No intervention | VD-born infants, receiving exclusive breast-feeding with mother's own breast milk (non-randomized) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start23 Sep 2021
- Primary completion29 Nov 2022
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD, Pleven, Bulgaria
- Responsible party
- Sponsor
- Investigators
- Victoria Assoc. Prof. Dr. Atanasova, MD, PhD, Principal investigator, "Dr. Georgi Stranski" EAD, 91 "Vladimir Vazov" Str., 5809 Pleven, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991792
- Sponsor's protocol ID
- 510646
- Acronym
- GOLF-CS
- Status last verified
- May 2025
- First submitted
- 28 Jul 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of an Infant Formula Containing Synbiotics on the Composition of the Gut Microbiota in Infants Born Via Caesarean Section
- ClinicalTrials.gov ID
- NCT04991792
- Acronym / sponsor ID
- GOLF-CS / 510646
- Conditions
- Gut Microbiota
- Keywords
- Caesarean Section; Microbiota; Infant Formula; Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KGIndustry (pharma, biotech, devices)
- Collaborators
- University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD, Pleven, Bulgaria
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Standard Infant Formula with synbiotics (CS-born) | Experimental | Other: Intervention Group 1: Infant Formula with synbioticsCS born infants, randomized to receive infant formula with synbiotics |
| Standard Infant Formula with prebiotics (CS-born) | Experimental | Other: Intervention Group 2: Infant Formula with prebioticsCS born infants, randomized to receive infant formula with prebiotics |
| Control Group 1: Standard Infant Formula (CS-born) | Active comparator | Other: Control Group 1 and 2: Infant Formula without synbioticsCS born infants, randomized to receive standard infant formula without synbiotics |
| Control Group 2 : Standard Infant Formula (VD-born) | Active comparator | Other: Control Group 1 and 2: Infant Formula without synbioticsVD born infants, receiving standard infant formula without synbiotics (self-selected for formula-feeding = non-randomized) |
| Reference Group 1: Breastfed (CS-born) | No intervention | –CS-born infants, receiving exclusive breast-feeding with mother's own breast milk (non-randomized) |
| Reference Group 2: Breastfed (VD-born) | No intervention | –VD-born infants, receiving exclusive breast-feeding with mother's own breast milk (non-randomized) |
Who may qualify
- Ages
- 4 to 6 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group 1: Infant Formula with synbioticsInfants will receive infant formula during the first 6 months of life | Other | Standard Infant Formula with synbiotics (CS-born) |
| Intervention Group 2: Infant Formula with prebioticsInfants will receive infant formula during the first 6 months of life | Other | Standard Infant Formula with prebiotics (CS-born) |
| Control Group 1 and 2: Infant Formula without synbioticsInfants will receive infant formula during the first 6 months of life | Other | Control Group 1: Standard Infant Formula (CS-born), Control Group 2 : Standard Infant Formula (VD-born) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Assoc. Prof. Dr. Atanasova, MD, PhD principal investigator
"Dr. Georgi Stranski" EAD, 91 "Vladimir Vazov" Str., 5809 Pleven, Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group 1: Infant Formula with synbiotics and Intervention Group 2: Infant Formula with prebiotics in people with Gut Microbiota, run by HiPP GmbH & Co. Vertrieb KG at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.