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

Growth Clinical Trial

Official title:

Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929292
• Other study ID #: DAH-CL3-001
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2009
• Last updated: June 26, 2009
• Start date: November 2006
• Est. completion date: July 2008

Study information

• Verified date: June 2009
• Source: Sodilac
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Colic
• Growth

Intervention

Other:
• Modilac Dahlia 1
Infant formula used for non breastfed children with colic
• Modilac 1
Infant formula used for non breastfed children

Locations

Country	Name	City	State
France	Dr Francine Gressin-Cohen	Antony
France	Hôpital privé d'Antony	Antony
France	Hôpital Robert Ballanger	Aulnay sous Bois
France	Dr Brigitte Pacault	Boulogne Billancourt
France	Dr Michel Dogneton	Boulogne Billancourt
France	Dr Nassira Belaroussi Maamri	Boulogne Billancourt
France	Dr KALINDJIAN	Issy-les-Moulineaux
France	Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)	Lille
France	Dr Christophe Grillon	Meaux
France	Dr COUPRIE Claire	Paris
France	Dr RONZIER Monique	Paris
France	Dr Locquet André	Roncq

Sponsors (1)

Lead Sponsor	Collaborator
Sodilac

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crying duration per 24 hours		1 day before the first consumption ; 3 days before days 15 and 30	No
Secondary	Growth Parameters		Day 30	Yes
Secondary	Clinical Tolerance		3 days before days 15 and 30	No
Secondary	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	No
Secondary	Number of regurgitations per day		3 days before days 15 and 30	No
Secondary	Gas and abdominal distensions		3 days before days 15 and 30	No
Secondary	Necessary Additive treatments		3 days before days 15 and 30	No
Secondary	Parents' satisfaction		Days 15 and 30	No
Secondary	Agitation/Restlessness Period Duration		3 days before days 15 and 30	No