The Combiotic-Study (GOLFIII)

HiPP

Status: Terminated

Conditions: Healthy Term Infants

Treatments: Dietary Supplement: Control formula; Dietary Supplement: Synbiotic formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02221687

505564 - PEC10561

Details and patient eligibility

About

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.

Enrollment: 540 patients

Sex: All

Ages: 3 to 5 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.
• 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.

Exclusion criteria

• 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)
• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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540 participants in 3 patient groups, including a placebo group

Synbiotic formula

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Synbiotic formula

Control formula

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Control formula

Breast-fed group

No Intervention group

Description:

- 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)