Status:
TERMINATED
The Combiotic-Study
Lead Sponsor:
HiPP GmbH & Co. Vertrieb KG
Collaborating Sponsors:
Biofortis Mérieux NutriSciences
Conditions:
Healthy Term Infants
Eligibility:
All Genders
3-5 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT02221687
Start Date
August 1 2014
End Date
April 1 2021
Last Update
January 20 2022
Active Locations (25)
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1
Elie JABBOUR
Gémozac, Charente-Maritime, France, 17260
2
Christophe VIEL
La Rochelle, Charente-Maritime, France, 17000
3
C.I.C Pédiatrique - C.H.U. de Grenoble - Hôpital Couple-Enfant
Grenoble, Isère, France, 38043
4
C.I.C pédiatrique - C.H.U. de Nantes - Hôpital Mère-Enfant
Nantes, Loire-Atlantique, France, 44093