Color Synbiotics Study

Beneficial Bacteria in Gut Clinical Trial

Official title:

Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Synbiotics Mixtures on Gut Microbiota Composition in Healthy Infants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813175
• Other study ID #: COL.1.C.A
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: September 4, 2017
• Start date: May 2013
• Est. completion date: July 2016

Study information

• Verified date: September 2017
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 43 Days to 65 Days

Eligibility

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

Related Conditions & MeSH terms

• Beneficial Bacteria in Gut

Intervention

Other:
• Regular non-hydrolysed cow's milk I
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
• Regular non-hydrolysed cow's milk II
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
• Regular non-hydrolysed cow's milk - control
Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Thammasat Hospital	Klong Luang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group		baseline, week 6
Secondary	Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group		baseline, week 6
Secondary	Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group		baseline, week 6