Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic

This study has been completed.
Sponsor:
Information provided by:
Sodilac
ClinicalTrials.gov Identifier:
NCT00929292
First received: June 26, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 26, 2009
June 26, 2009
November 2006
July 2008   (final data collection date for primary outcome measure)
Crying duration per 24 hours [ Time Frame: 1 day before the first consumption ; 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Growth Parameters [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
  • Clinical Tolerance [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
  • Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms) [ Time Frame: Durind the 15 first days of the diet and during the 15 last days of the diet ] [ Designated as safety issue: No ]
  • Number of regurgitations per day [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
  • Gas and abdominal distensions [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
  • Necessary Additive treatments [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
  • Parents' satisfaction [ Time Frame: Days 15 and 30 ] [ Designated as safety issue: No ]
  • Agitation/Restlessness Period Duration [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.

The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.

This double-blind, placebo-controlled study was undertaken with 66 healthy infants with colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or with the control formula (CF) and evaluated for efficacy and safety parameters at days 15 and 30.

Both parents provided informed written consent.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Growth
  • Colic
  • Other: Modilac Dahlia 1
    Infant formula used for non breastfed children with colic
    Other Name: Dahlia
  • Other: Modilac 1
    Infant formula used for non breastfed children
    Other Name: Modilac
  • Experimental: Modilac Dahlia 1
    Formula enriched with alpha-lactalbumin and containing a probiotic
    Intervention: Other: Modilac Dahlia 1
  • Placebo Comparator: Modilac 1
    Regular milk
    Intervention: Other: Modilac 1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy term infants with a gestational age ranging from 37 to 42 weeks
  • Non breastfed children
  • Infants with normal growth
  • Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks
  • These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)
  • Apgar score > 5 to 7 minutes

Exclusion Criteria:

  • Infants with severe regurgitations
  • Newborn currently participating in another trial
  • Infants presenting a metabolic, nervous or organic disease able to interfere with the study
  • Infants presenting lactose intolerance
  • Evidence of protein cow's milk allergy
  • Mother who wants to keep breasfeeding
Both
up to 3 Months
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00929292
DAH-CL3-001
No
Pr Christophe Dupont, Hôpital Saint Vincent de Paul
Sodilac
Not Provided
Principal Investigator: Christophe Dupont, PhD Hôpital Saint Vincent de Paul
Sodilac
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP