Color Synbiotics 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

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-07-31

Brief Summary

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This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.

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Detailed Description

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Conditions

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Beneficial Bacteria in Gut

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention Group I

Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I

Group Type ACTIVE_COMPARATOR

Regular non-hydrolysed cow's milk I

Intervention Type OTHER

Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I

Interventional Group II

Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II

Group Type ACTIVE_COMPARATOR

Regular non-hydrolysed cow's milk II

Intervention Type OTHER

Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II

Control Group

Regular non-hydrolysed cow's milk based infant formula

Group Type PLACEBO_COMPARATOR

Regular non-hydrolysed cow's milk - control

Intervention Type OTHER

Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture

Reference Group

Exclusively breast-fed infants

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Regular non-hydrolysed cow's milk I

Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I

Intervention Type OTHER

Regular non-hydrolysed cow's milk II

Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II

Intervention Type OTHER

Regular non-hydrolysed cow's milk - control

Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy term infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) aged 46 - 65 days (inclusive) at entry into the study
* Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
* Parents' or legal guardian's written informed consent

Exclusion Criteria

* Being weaned before inclusion (introduction of any other foods other than formula or human milk)
* Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
* Medical condition for which a special diet other than standard (non hydrolised) cow's milk-based infant formula is required
* Known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
* Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks prior to entry into the study
* Received Inactivated Poliovirus Vaccine (IPV) or Rotavirus Vaccine (RV) prior to entry into the study
* Gastroenteritis or diarrhoea in the last two weeks prior to entry into the study
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements

Minimum Eligible Age

43 Days

Maximum Eligible Age

65 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes