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Trial record 2 of 136 for:    color II

Color Synbiotics Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier:
NCT01813175
First received: March 12, 2013
Last updated: August 5, 2016
Last verified: August 2016
  Purpose
This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.

Condition Intervention Phase
Beneficial Bacteria in Gut
Other: Regular non-hydrolysed cow's milk I
Other: Regular non-hydrolysed cow's milk II
Other: Regular non-hydrolysed cow's milk - control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Synbiotics Mixtures on Gut Microbiota Composition in Healthy Infants.

Further study details as provided by Danone Asia Pacific Holdings Pte, Ltd.:

Primary Outcome Measures:
  • Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]
  • Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]

Enrollment: 290
Study Start Date: May 2013
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention Group I
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
Other: Regular non-hydrolysed cow's milk I
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
Active Comparator: Interventional Group II
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
Other: Regular non-hydrolysed cow's milk II
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
Placebo Comparator: Control Group
Regular non-hydrolysed cow's milk based infant formula
Other: Regular non-hydrolysed cow's milk - control
Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture
No Intervention: Reference Group
Exclusively breast-fed infants

  Eligibility

Ages Eligible for Study:   43 Days to 65 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813175

Locations
Thailand
Thammasat Hospital
Klong Luang, Pathumthani, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
  More Information

Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT01813175     History of Changes
Other Study ID Numbers: COL.1.C.A 
Study First Received: March 12, 2013
Last Updated: August 5, 2016
Health Authority: Thailand: Food and Drug Administration

ClinicalTrials.gov processed this record on December 09, 2016