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
  Purpose

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.


Condition Intervention Phase
Growth
Colic
Other: Modilac Dahlia 1
Other: Modilac 1
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.

Resource links provided by NLM:


Further study details as provided by Sodilac:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: November 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modilac Dahlia 1
Formula enriched with alpha-lactalbumin and containing a probiotic
Other: Modilac Dahlia 1
Infant formula used for non breastfed children with colic
Other Name: Dahlia
Placebo Comparator: Modilac 1
Regular milk
Other: Modilac 1
Infant formula used for non breastfed children
Other Name: Modilac

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00929292

Locations
France
Hôpital privé d'Antony
Antony, France, 92166
Dr Francine Gressin-Cohen
Antony, France, 92160
Hôpital Robert Ballanger
Aulnay sous Bois, France, 93602
Dr Brigitte Pacault
Boulogne Billancourt, France, 92100
Dr Nassira Belaroussi Maamri
Boulogne Billancourt, France, 92100
Dr Michel Dogneton
Boulogne Billancourt, France, 92100
Dr KALINDJIAN
Issy-les-Moulineaux, France, 92130
Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)
Lille, France, 59020
Dr Christophe Grillon
Meaux, France, 77100
Dr COUPRIE Claire
Paris, France, 75013
Dr RONZIER Monique
Paris, France, 75015
Dr Locquet André
Roncq, France, 59223
Sponsors and Collaborators
Sodilac
Investigators
Principal Investigator: Christophe Dupont, PhD Hôpital Saint Vincent de Paul
  More Information

No publications provided

Responsible Party: Pr Christophe Dupont, Hôpital Saint Vincent de Paul
ClinicalTrials.gov Identifier: NCT00929292     History of Changes
Other Study ID Numbers: DAH-CL3-001
Study First Received: June 26, 2009
Last Updated: June 26, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sodilac:
Infant formula
Alpha-lactalbumin
Protein composition
Colic
Probiotics

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 20, 2014