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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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