Color Synbiotics Study

Not Applicable

Completed

• Conditions: Beneficial Bacteria in Gut
• Interventions: Other: Regular non-hydrolysed cow's milk I; Other: Regular non-hydrolysed cow's milk II; Other: Regular non-hydrolysed cow's milk - control

• Registration Number: NCT01813175
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-18
• Study Start: 2013-05
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

• Exclusion criteria for run-in period (visit 1, screening) are:
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group I	Regular non-hydrolysed cow's milk I	Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
Interventional Group II	Regular non-hydrolysed cow's milk II	Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
Control Group	Regular non-hydrolysed cow's milk - control	Regular non-hydrolysed cow's milk based infant formula

Primary Outcome Measures

Name	Time	Method
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group	baseline, week 6

Secondary Outcome Measures

Name	Time	Method
Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group	baseline, week 6
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group	baseline, week 6

Trial Locations

Locations (3)

Thammasat Hospital; 🇹🇭 Klong Luang, Pathumthani, Thailand

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand