Healthy Term InfantsGOLFIIINCT02221687
The Combiotic-Study
A study testing Synbiotic formula in people with Healthy Term Infants, run by HiPP GmbH & Co. Vertrieb KG at 25 sites in France.
Trial summary
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula. Read more about this study
- Who is it for?
- Ages 3 to 5 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infants
- What is being tested?
- Synbiotic formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 25 sitesFrance
- Study dates
- Aug 2014to Apr 2021
- 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 3 to 5 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants
- Female or male gender
- Gestational age between 37 and 41 weeks completed (= 41 weeks + 6 days)
- Age at time of V1 visit : 4 +/- 7 days
- Birth weight between 2500 ans 4200g, with regular weight gain (≥ 150g / week)
- Two legal representatives (parent(s) / guardian(s)) who are capable of and willing to comply with the protocol and have signed the informed consent in accordance with legal requirements.
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- at least one of the legal representatives is affiliated to with a social security scheme.
- Additionnaly , criteria of inclusion in one of the formula-fed groups or in the breast-fed group, respectively, are the following:
- To be included in one of the formula arm, infants will have to be exclusively formula-fed (no breast milk meal) at the time of V1 visit (randomization).
- or
- To be included in the breastfeeding arm, infants will have to be exclusively breast-fed (no more than one formula meal per day) at V1 visit (randomization) and its mother will have to be willing to pursue exclusive breastfeeding at least until the infant will be 4-month old.
Who cannot join
- Intensive care during at least the first 14 days of life
- Neonatal health problems, such as: respiratory distress, asphyxia, hypoglycemia, sepsis, NEC (necrotizing enterocolitis),...
- Clinical evidence of chronic illness or gastrointestinal disorders such as : GER (Gastrooesophageal Reflux), gastroenteritis,...
- Known metabolic disorders, such as diabetes, lactose intolerance,....
- Known immune deficiency
- Subjects recommended to receive formula with hydrolized protein (e.g. children with allergy risk)
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- Subject under oral antibiotic treatment at V1 visit
- Participation in another biomedical study
- Whose legal representatives have psychological or linguistic incapability to sign the informed consent form
- Reasons to presume that parents are unable to meet the study plan requirements (e.g. impossibility to contact study representatives in case of emergency, drug addiction etc)
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Alain PALOMBA
Angers, Maine-et-Loire, 49000
Christophe RONDEAU
Angers, Maine-et-Loire, 49000
Damien GODIN
Angers, Maine-et-Loire, 49000
Daniel GOMBAUD
Angers, Maine-et-Loire, 49000
Jean-François FOUCAULT
Angers, Maine-et-Loire, 49000
Michel LAMBERT
Angers, Maine-et-Loire, 49000
Nolwenn RONCERAY
Angers, Maine-et-Loire, 49000
Philippe REMAUD
Angers, Maine-et-Loire, 49000
Pierre-André FERRAND
Angers, Maine-et-Loire, 49000
Vanessa BERNAND
Angers, Maine-et-Loire, 49000
Francisco MARTINEZ-CORTES
Angers, Maine-et-Loire, 49100
Damien GUILLON
Angers, Maine-et-Loire, 49120
Christine REGIMBART
Bécon-les-Granits, Maine-et-Loire, 49370
Elie JABBOUR
Gémozac, Charente-Maritime, 17260
C.I.C Pédiatrique - C.H.U. de Grenoble - Hôpital Couple-Enfant
Grenoble, Isère, 38043
Christophe VIEL
La Rochelle, Charente-Maritime, 17000
Alain BATY
Laval, Mayenne, 53000
Christian DUROY
Laval, Mayenne, 53000
François RICHARD
Laval, Mayenne, 53000
Patrick ROBERT
Laval, Mayenne, 53000
Antoine LEPELLETIER
Montreuil, Maine-et-Loire, 49460
C.I.C pédiatrique - C.H.U. de Nantes - Hôpital Mère-Enfant
Nantes, Loire-Atlantique, 44093
Benoit DAGUZAN
Segré, Maine-et-Loire, 49500
Didier NOURRY
Tiercé, Maine-et-Loire, 49125
Philippe IGIGABEL
Tiercé, Maine-et-Loire, 49125
About this study
Official title: Evaluation of the Efficacy and Safety of an Infant Formula Containing Synbiotics and Its Effects on the Incidence of Infectious Diseases in the Infant Gut : a Double-blind, Randomized, Controlled Interventional Study
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.
- Conditions
- Healthy Term Infants
- Being tested
- Synbiotic formula, Control formula
- Keywords
- synbiotic formula, infant formula, diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic formulaDietary supplement
Standard milk formula enriched with a prebiotic fiber and a probiotic strain
Control formulaDietary supplement
Standard milk formula without pre and probiotic
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic formula | Experimental | Synbiotic formula : standard formula enriched with a prebiotic fiber and a probiotic strain
Dose : variable number of powder scoops, adapted to the infant's age and weight, and addition of the defined amount of water, according to the Dose and Drinking Amount table.
Route : oral, ad libitum
Duration of product intake:
* Synbiotic IF : 5 months of consumption (from the inclusion until 6 months completed of age)
* Synbiotic FoF: 6 months of consumption (from 6 to 12 months of age) Receives: Dietary Supplement: Synbiotic formula |
| Control formula | Placebo comparator | Control formula : standard formula without pre and probiotic
Dose : variable number of powder scoops, adapted to the infant's age and weight, and addition of the defined amount of water according to the Dose and Drinking Amount table.
Route: oral, ad libitum
Duration of product intake:
* Control IF : 5 months of consumption (from the inclusion until 6 months completed of age)
* Control FoF : 6 months of consumption (from 6 to 12 months of age) Receives: Dietary Supplement: Control formula |
| Breast-fed group | No intervention | - Breast milk as exclusive feeding (no more than one formula meal per day), from birth until at least 4 months of age. Then, when the mother decides to stop breastfeeding, the infants can consume any formula on parent's choice respecting forbidden products list. Dose: * Breast milk : on demand Route : oral, ad libitum Duration of product intake: * Breast milk : at least 4 month (from birth until at least 4 months of age) |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Cumulative) number of infectious diarrhea episodes per subject during the first year of life.
Difference between formula groups are evaluated via incidence rate based on number of subjects.
In formula-fed infants, diarrhea is defined as three or more loose or watery stools in 24 hours with or without fever or vomiting (according to WHO and ESPGHAN definition). For breast-fed infants, a change in stool consistency versus previous stool consistency is more indicative of diarrhea than stool number.
Diarrhea episode is considered as ended as soon as 2 consecutive non-watery stools are observed or no stools are observed in 24 hours.
Measured: one year
Secondary outcomes (57)
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile
Measured: 4 months
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile
Measured: 1 year
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile
Measured: 2 years
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile
Measured: 3 years
Analysis of fecal microbiota by molecular analysis from frozen stools in diarrhea samples
levels of potential pathogens causing diarrhea including rotavirus, norovirus, Salmonella enterica, Campylobacter jejuni, Clostridium difficile, Clostridium perfringens, Escherichia coli (potential pathogenic bacteria will be screened only in case of negative testing for viruses on sample collected within 72 hours after beginning of the diarrhea episode);
Measured: 1 year
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
short chain fatty acids (SCFA): acetate, propionate, butyrate;
Measured: 4 months
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
short chain fatty acids (SCFA): acetate, propionate, butyrate;
Measured: 1 year
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
short chain fatty acids (SCFA): acetate, propionate, butyrate;
Measured: 2 years
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
short chain fatty acids (SCFA): acetate, propionate, butyrate;
Measured: 3 years
Characteristics of bowel movements and stools
- assessed through a 3-day diary filled in by parents
- average daily number of bowel movements;
- (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially
- average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale);
- dominant stool color per visit
Measured: 4 months
Characteristics of bowel movements and stools
- assessed through a 3-day diary filled in by parents
- average daily number of bowel movements;
- (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially
- average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale);
- dominant stool color per visit
Measured: 6 months
Characteristics of bowel movements and stools
- assessed through a 3-day diary filled in by parents
- average daily number of bowel movements;
- (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially
- average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale);
- dominant stool color per visit
Measured: 9 months
Characteristics of bowel movements and stools
- assessed through a 3-day diary filled in by parents
- average daily number of bowel movements;
- (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially
- average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale);
- dominant stool color per visit
Measured: 1 year
Characteristics of bowel movements and stools
- assessed through a 3-day diary filled in by parents
- average daily number of bowel movements;
- (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially
- average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale);
- dominant stool color per visit
Measured: 2 years
Characteristics of bowel movements and stools
- assessed through a 3-day diary filled in by parents
- average daily number of bowel movements;
- (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially
- average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale);
- dominant stool color per visit
Measured: 3 years
Characteristics of bowel movements during diarrhea episodes
- assessed through a diary filled in by parents during diarrhea episodes
- average daily number of bowel movements per diarrhea episode;
- average duration (number of days) of diarrhea episodes;
- total number of days with diarrhea, within the first year of age (between V1 and V5);
- (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) per diarrhea episode.
Measured: 1 year
Levels of fecal IgA and fecal calprotectin in planned stool samples
Measured: 4 months
Levels of fecal IgA and fecal calprotectin in planned stool samples
Measured: 1 year
Levels of fecal IgA and fecal calprotectin in planned stool samples
Measured: 2 years
Levels of fecal IgA and fecal calprotectin in planned stool samples
Measured: 3 years
Number and duration of infectious diseases
Especially: otitis media, infections of upper and lower respiratory tract and of urinary tract;
Measured: 3 years
Number and duration of fever episodes;
Measured: 3 years
Number and duration of antibiotic treatment.
Measured: 3 years
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Measured: 4 weeks
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Measured: 4 months
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Measured: 6 months
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Measured: 9 months
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Measured: 1 year
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Measured: 2 years
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Measured: 3 years
Child's behavior
Assessed through a 3-day diary filled in by parents
- Average sleep duration and crying duration per 24 hours;
Measured: 4 months
Child's behavior
Assessed through a 3-day diary filled in by parents
- Average sleep duration and crying duration per 24 hours;
Measured: 6 months
Child's behavior
Assessed through a 3-day diary filled in by parents
- Average sleep duration and crying duration per 24 hours;
Measured: 9 months
Child's behavior
Assessed through a 3-day diary filled in by parents
- Average sleep duration and crying duration per 24 hours;
Measured: 1 year
Child's behavior
Assessed through a 3-day diary filled in by parents
- Average sleep duration and crying duration per 24 hours;
Measured: 2 years
Child's behavior
Assessed through a 3-day diary filled in by parents
- Average sleep duration and crying duration per 24 hours;
Measured: 3 years
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents
- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Measured: 4 months
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents
- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Measured: 6 months
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents
- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Measured: 9 months
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents
- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Measured: 1 year
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents
- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Measured: 2 years
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents
- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Measured: 3 years
Suitability for daily use
Assessed through a 3-day diary filled in by parents
- average daily consumption: drinking amounts and formula acceptance;
Measured: 4 months
Suitability for daily use
Assessed through a 3-day diary filled in by parents
- average daily consumption: drinking amounts and formula acceptance;
Measured: 6 months
Suitability for daily use
Assessed through a 3-day diary filled in by parents
- average daily consumption: drinking amounts and formula acceptance;
Measured: 9 months
Suitability for daily use
Assessed through a 3-day diary filled in by parents
- average daily consumption: drinking amounts and formula acceptance;
Measured: 1 year
Suitability for daily use
Assessed through a 3-day diary filled in by parents
- average daily consumption: drinking amounts and formula acceptance;
Measured: 2 years
Suitability for daily use
Assessed through a 3-day diary filled in by parents
- average daily consumption: drinking amounts and formula acceptance;
Measured: 3 years
Adverse events (AE)
Assessed through a 3-day diary filled in by parents
- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Measured: 4 months
Adverse events (AE)
Assessed through a 3-day diary filled in by parents
- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Measured: 6 months
Adverse events (AE)
Assessed through a 3-day diary filled in by parents
- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Measured: 9 months
Adverse events (AE)
Assessed through a 3-day diary filled in by parents
- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Measured: 1 year
Adverse events (AE)
Assessed through a 3-day diary filled in by parents
- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Measured: 2 years
Adverse events (AE)
Assessed through a 3-day diary filled in by parents
- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Measured: 3 years
Number and duration of fever episodes;
Measured: 1 year
Number and duration of antibiotic treatment.
Measured: 1 year
Number and duration of infectious diseases
Especially: otitis media, infections of upper and lower respiratory tract and of urinary tract;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2019
- Study completionApr 2021
Why it stopped: Recruitment of breastfed infants was very slow. Decision with PI (05/2018): Termination (80/100); no implication on primary outcome. Predetermined number of breastfed infants (n=100) was arbitray choice. Formula groups completed (460/460) 12/2017.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Term InfantsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Hugues Piloquet, Pediatrician, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221687
- Sponsor's protocol ID
- 505564 - PEC10561
- Acronym
- GOLFIII
- Status last verified
- Jan 2022
- First submitted
- 19 Aug 2014
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Piloquet H, Vrignaud B, Gillaizeau F, Capronnier O, Berding K, Gunther J, Hecht C, Regimbart C; GOLF III Study Group. Efficacy and safety of a synbiotic infant formula for the prevention of respiratory and gastrointestinal infections: a randomized controlled trial. Am J Clin Nutr. 2024 May;119(5):1259-1269. doi: 10.1016/j.ajcnut.2024.03.005. Epub 2024 Mar 10.
PubMed 38462218Lagkouvardos I, Intze E, Schaubeck M, Rooney JP, Hecht C, Piloquet H, Clavel T. Early life gut microbiota profiles linked to synbiotic formula effects: a randomized clinical trial in European infants. Am J Clin Nutr. 2023 Feb;117(2):326-339. doi: 10.1016/j.ajcnut.2022.11.012. Epub 2022 Dec 21.
PubMed 36811568
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of an Infant Formula Containing Synbiotics and Its Effects on the Incidence of Infectious Diseases in the Infant Gut : a Double-blind, Randomized, Controlled Interventional Study
- ClinicalTrials.gov ID
- NCT02221687
- Acronym / sponsor ID
- GOLFIII / 505564 - PEC10561
- Conditions
- Healthy Term Infants
- Keywords
- synbiotic formula, infant formula, diarrhea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment of breastfed infants was very slow. Decision with PI (05/2018): Termination (80/100); no implication on primary outcome. Predetermined number of breastfed infants (n=100) was arbitray choice. Formula groups completed (460/460) 12/2017.
- Enrolment
- 540 participants (actual)
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KGIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Study start
- Aug 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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.
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synbiotic formula | Experimental | Dietary Supplement: Synbiotic formulaSynbiotic formula : standard formula enriched with a prebiotic fiber and a probiotic strain Dose : variable number of powder scoops, adapted to the infant's age and weight, and addition of the defined amount of water, according to the Dose and Drinking Amount table. Route : oral, ad libitum Duration of product intake: * Synbiotic IF : 5 months of consumption (from the inclusion until 6 months completed of age) * Synbiotic FoF: 6 months of consumption (from 6 to 12 months of age) |
| Control formula | Placebo comparator | Dietary Supplement: Control formulaControl formula : standard formula without pre and probiotic Dose : variable number of powder scoops, adapted to the infant's age and weight, and addition of the defined amount of water according to the Dose and Drinking Amount table. Route: oral, ad libitum Duration of product intake: * Control IF : 5 months of consumption (from the inclusion until 6 months completed of age) * Control FoF : 6 months of consumption (from 6 to 12 months of age) |
| Breast-fed group | No intervention | –- Breast milk as exclusive feeding (no more than one formula meal per day), from birth until at least 4 months of age. Then, when the mother decides to stop breastfeeding, the infants can consume any formula on parent's choice respecting forbidden products list. Dose: * Breast milk : on demand Route : oral, ad libitum Duration of product intake: * Breast milk : at least 4 month (from birth until at least 4 months of age) |
Who may qualify
- Ages
- 3 to 5 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Healthy term infants
- Female or male gender
- Gestational age between 37 and 41 weeks completed (= 41 weeks + 6 days)
- Age at time of V1 visit : 4 +/- 7 days
- Birth weight between 2500 ans 4200g, with regular weight gain (≥ 150g / week)
Key exclusion criteria (10 listed)
- Intensive care during at least the first 14 days of life
- Neonatal health problems, such as: respiratory distress, asphyxia, hypoglycemia, sepsis, NEC (necrotizing enterocolitis),...
- Clinical evidence of chronic illness or gastrointestinal disorders such as : GER (Gastrooesophageal Reflux), gastroenteritis,...
- Known metabolic disorders, such as diabetes, lactose intolerance,....
- Known immune deficiency
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 |
|---|---|---|
| Synbiotic formulaStandard milk formula enriched with a prebiotic fiber and a probiotic strain | Dietary supplement | Synbiotic formula |
| Control formulaStandard milk formula without pre and probiotic | Dietary supplement | Control formula |
Primary outcome
(Cumulative) number of infectious diarrhea episodes per subject during the first year of life.
Time frame: one year
Difference between formula groups are evaluated via incidence rate based on number of subjects. In formula-fed infants, diarrhea is defined as three or more loose or watery stools in 24 hours with or without fever or vomiting (according to WHO and ESPGHAN definition). For breast-fed infants, a change in stool consistency versus previous stool consistency is more indicative of diarrhea than stool number. Diarrhea episode is considered as ended as soon as 2 consecutive non-watery stools are observed or no stools are observed in 24 hours.
57 secondary outcomes
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Time frame: 4 months
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Time frame: 1 year
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Time frame: 2 years
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Time frame: 3 years
Analysis of fecal microbiota by molecular analysis from frozen stools in diarrhea samples
Time frame: 1 year
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
Time frame: 4 months
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
Time frame: 1 year
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
Time frame: 2 years
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
Time frame: 3 years
Characteristics of bowel movements and stools
Time frame: 4 months
Characteristics of bowel movements and stools
Time frame: 6 months
Characteristics of bowel movements and stools
Time frame: 9 months
Characteristics of bowel movements and stools
Time frame: 1 year
Characteristics of bowel movements and stools
Time frame: 2 years
Characteristics of bowel movements and stools
Time frame: 3 years
Characteristics of bowel movements during diarrhea episodes
Time frame: 1 year
Levels of fecal IgA and fecal calprotectin in planned stool samples
Time frame: 4 months
Levels of fecal IgA and fecal calprotectin in planned stool samples
Time frame: 1 year
Levels of fecal IgA and fecal calprotectin in planned stool samples
Time frame: 2 years
Levels of fecal IgA and fecal calprotectin in planned stool samples
Time frame: 3 years
Number and duration of infectious diseases
Time frame: 3 years
Number and duration of fever episodes;
Time frame: 3 years
Number and duration of antibiotic treatment.
Time frame: 3 years
Infants growth measured by anthropometric measurements
Time frame: 4 weeks
Infants growth measured by anthropometric measurements
Time frame: 4 months
Infants growth measured by anthropometric measurements
Time frame: 6 months
Infants growth measured by anthropometric measurements
Time frame: 9 months
Infants growth measured by anthropometric measurements
Time frame: 1 year
Infants growth measured by anthropometric measurements
Time frame: 2 years
Infants growth measured by anthropometric measurements
Time frame: 3 years
Child's behavior
Time frame: 4 months
Child's behavior
Time frame: 6 months
Child's behavior
Time frame: 9 months
Child's behavior
Time frame: 1 year
Child's behavior
Time frame: 2 years
Child's behavior
Time frame: 3 years
Minor gastrointestinal disorders (digestive tolerance)
Time frame: 4 months
Minor gastrointestinal disorders (digestive tolerance)
Time frame: 6 months
Minor gastrointestinal disorders (digestive tolerance)
Time frame: 9 months
Minor gastrointestinal disorders (digestive tolerance)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Recruitment of breastfed infants was very slow. Decision with PI (05/2018): Termination (80/100); no implication on primary outcome. Predetermined number of breastfed infants (n=100) was arbitray choice. Formula groups completed (460/460) 12/2017.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Derived from this study: PubMed 38462218Piloquet H, Vrignaud B, Gillaizeau F, Capronnier O, Berding K, Gunther J, Hecht C, Regimbart C; GOLF III Study Group. Efficacy and safety of a synbiotic infant formula for the prevention of respiratory and gastrointestinal infections: a randomized controlled trial. Am J Clin Nutr. 2024 May;119(5):1259-1269. doi: 10.1016/j.ajcnut.2024.03.005. Epub 2024 Mar 10.
- Derived from this study: PubMed 36811568Lagkouvardos I, Intze E, Schaubeck M, Rooney JP, Hecht C, Piloquet H, Clavel T. Early life gut microbiota profiles linked to synbiotic formula effects: a randomized clinical trial in European infants. Am J Clin Nutr. 2023 Feb;117(2):326-339. doi: 10.1016/j.ajcnut.2022.11.012. Epub 2022 Dec 21.
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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.
Hugues Piloquet, Pediatrician principal investigator
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic formula in people with Healthy Term Infants, run by HiPP GmbH & Co. Vertrieb KG at 25 sites in France.
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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Recruitment of breastfed infants was very slow. Decision with PI (05/2018): Termination (80/100); no implication on primary outcome. Predetermined number of breastfed infants (n=100) was arbitray choice. Formula groups completed (460/460) 12/2017.). Results are not available in the source record.
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?
(Cumulative) number of infectious diarrhea episodes per subject during the first year of life. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02221687, which also lists 2 linked publications.
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 20 Jan 2022.