MedDataX Logo

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

NCT ID: NCT00929292

Last Updated: 2009-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth Colic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Infant formula Alpha-lactalbumin Protein composition Colic Probiotics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Modilac Dahlia 1

Formula enriched with alpha-lactalbumin and containing a probiotic

Group Type EXPERIMENTAL

Modilac Dahlia 1

Intervention Type OTHER

Infant formula used for non breastfed children with colic

Modilac 1

Regular milk

Group Type PLACEBO_COMPARATOR

Modilac 1

Intervention Type OTHER

Infant formula used for non breastfed children

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modilac Dahlia 1

Infant formula used for non breastfed children with colic

Intervention Type OTHER

Modilac 1

Infant formula used for non breastfed children

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dahlia Modilac

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Weeks

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sodilac

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hôpital Saint Vincent de Paul

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christophe Dupont, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Vincent de Paul

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr Francine Gressin-Cohen

Antony, , France

Site Status

Hôpital privé d'Antony

Antony, , France

Site Status

Hôpital Robert Ballanger

Aulnay-sous-Bois, , France

Site Status

Dr Brigitte Pacault

Boulogne-Billancourt, , France

Site Status

Dr Michel Dogneton

Boulogne-Billancourt, , France

Site Status

Dr Nassira Belaroussi Maamri

Boulogne-Billancourt, , France

Site Status

Dr KALINDJIAN

Issy-les-Moulineaux, , France

Site Status

Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)

Lille, , France

Site Status

Dr Christophe Grillon

Meaux, , France

Site Status

Dr COUPRIE Claire

Paris, , France

Site Status

Dr RONZIER Monique

Paris, , France

Site Status

Dr Locquet André

Roncq, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DAH-CL3-001

Identifier Type: -

Identifier Source: org_study_id