NCT00929292

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
Last Updated

June 29, 2009

Status Verified

June 1, 2009

Enrollment Period

1.7 years

First QC Date

June 26, 2009

Last Update Submit

June 26, 2009

Conditions

GrowthColic

Keywords

Infant formulaAlpha-lactalbuminProtein compositionColicProbiotics

Outcome Measures

Primary Outcomes (1)

  • Crying duration per 24 hours

    1 day before the first consumption ; 3 days before days 15 and 30

Secondary Outcomes (8)

  • Growth Parameters

    Day 30

  • Clinical Tolerance

    3 days before days 15 and 30

  • Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms)

    Durind the 15 first days of the diet and during the 15 last days of the diet

  • Number of regurgitations per day

    3 days before days 15 and 30

  • Gas and abdominal distensions

    3 days before days 15 and 30

  • +3 more secondary outcomes

Study Arms (2)

Modilac Dahlia 1

EXPERIMENTAL

Formula enriched with alpha-lactalbumin and containing a probiotic

Other: Modilac Dahlia 1

Modilac 1

PLACEBO COMPARATOR

Regular milk

Other: Modilac 1

Interventions

Modilac Dahlia 1OTHER

Infant formula used for non breastfed children with colic

Also known as: Dahlia
Modilac Dahlia 1
Modilac 1OTHER

Infant formula used for non breastfed children

Also known as: Modilac
Modilac 1

Eligibility Criteria

Age3 Weeks - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Dr Francine Gressin-Cohen

Antony, 92160, France

Location

Hôpital privé d'Antony

Antony, 92166, France

Location

Hôpital Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Dr Brigitte Pacault

Boulogne-Billancourt, 92100, France

Location

Dr Michel Dogneton

Boulogne-Billancourt, 92100, France

Location

Dr Nassira Belaroussi Maamri

Boulogne-Billancourt, 92100, France

Location

Dr KALINDJIAN

Issy-les-Moulineaux, 92130, France

Location

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

Lille, 59020, France

Location

Dr Christophe Grillon

Meaux, 77100, France

Location

Dr COUPRIE Claire

Paris, 75013, France

Location

Dr RONZIER Monique

Paris, 75015, France

Location

Dr Locquet André

Roncq, 59223, France

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Christophe Dupont, PhD

    Hôpital Saint Vincent de Paul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2009

First Posted

June 29, 2009

Study Start

November 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 29, 2009

Record last verified: 2009-06

Locations

FR(12)