The Combiotic-Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Term Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Synbiotic formula

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)

Group Type EXPERIMENTAL

Synbiotic formula

Intervention Type DIETARY_SUPPLEMENT

Standard milk formula enriched with a prebiotic fiber and a probiotic strain

Control formula

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)

Group Type PLACEBO_COMPARATOR

Control formula

Intervention Type DIETARY_SUPPLEMENT

Standard milk formula without pre and probiotic

Breast-fed group

\- 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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Synbiotic formula

Standard milk formula enriched with a prebiotic fiber and a probiotic strain

Intervention Type DIETARY_SUPPLEMENT

Control formula

Standard milk formula without pre and probiotic

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

3 Weeks

Maximum Eligible Age

5 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugues Piloquet, Pediatrician

Role: PRINCIPAL_INVESTIGATOR

Locations

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Elie JABBOUR

Gémozac, Charente-Maritime, France

Site Status

Christophe VIEL

La Rochelle, Charente-Maritime, France

Site Status

C.I.C Pédiatrique - C.H.U. de Grenoble - Hôpital Couple-Enfant

Grenoble, Isère, France

Site Status