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

June 26, 2009 updated by: Sodilac

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Antony, France, 92166
        • Hôpital Privé d'Antony
      • Antony, France, 92160
        • Dr Francine Gressin-Cohen
      • Aulnay sous Bois, France, 93602
        • Hopital Robert Ballanger
      • Boulogne Billancourt, France, 92100
        • Dr Brigitte Pacault
      • Boulogne Billancourt, France, 92100
        • Dr Michel Dogneton
      • Boulogne Billancourt, France, 92100
        • Dr Nassira Belaroussi Maamri
      • Issy-les-Moulineaux, France, 92130
        • Dr KALINDJIAN
      • Lille, France, 59020
        • Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)
      • Meaux, France, 77100
        • Dr Christophe Grillon
      • Paris, France, 75013
        • Dr COUPRIE Claire
      • Paris, France, 75015
        • Dr RONZIER Monique
      • Roncq, France, 59223
        • Dr Locquet André

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 weeks to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Dahlia
Placebo Comparator: Modilac 1
Regular milk
Other: Modilac 1
Infant formula used for non breastfed children
Other Names:
  • Modilac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Crying duration per 24 hours
Time Frame: 1 day before the first consumption ; 3 days before days 15 and 30
1 day before the first consumption ; 3 days before days 15 and 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Growth Parameters
Time Frame: Day 30
Day 30
Clinical Tolerance
Time Frame: 3 days before days 15 and 30
3 days before days 15 and 30
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
Durind the 15 first days of the diet and during the 15 last days of the diet
Number of regurgitations per day
Time Frame: 3 days before days 15 and 30
3 days before days 15 and 30
Gas and abdominal distensions
Time Frame: 3 days before days 15 and 30
3 days before days 15 and 30
Necessary Additive treatments
Time Frame: 3 days before days 15 and 30
3 days before days 15 and 30
Parents' satisfaction
Time Frame: Days 15 and 30
Days 15 and 30
Agitation/Restlessness Period Duration
Time Frame: 3 days before days 15 and 30
3 days before days 15 and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sodilac

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

June 29, 2009

Last Update Submitted That Met QC Criteria

June 26, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAH-CL3-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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