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

Phase 3

Completed

• Conditions: Growth; Colic
• Interventions: Other: Modilac 1; Other: Modilac Dahlia 1

• Registration Number: NCT00929292
• Lead Sponsor: Sodilac

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.

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 Timeline

• Study Start: 2006-11
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-06
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Last Update Submitted: 2009-06-26
• Study First Posted: 2009-06-29
• Last Update Posted: 2009-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modilac 1	Modilac 1	Regular milk
Modilac Dahlia 1	Modilac Dahlia 1	Formula enriched with alpha-lactalbumin and containing a probiotic

Primary Outcome Measures

Name	Time	Method
Crying duration per 24 hours	1 day before the first consumption ; 3 days before days 15 and 30

Secondary Outcome Measures

Name	Time	Method
Number of regurgitations per day	3 days before days 15 and 30
Gas and abdominal distensions	3 days before days 15 and 30
Necessary Additive treatments	3 days before days 15 and 30
Parents' satisfaction	Days 15 and 30
Agitation/Restlessness Period Duration	3 days before days 15 and 30
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

Trial Locations

Locations (12)

Groupe Hospitalier de l'Institut Catholique de Lille (GHICL); 🇫🇷 Lille, France

Dr Francine Gressin-Cohen; 🇫🇷 Antony, France

Hôpital privé d'Antony; 🇫🇷 Antony, France

Dr Nassira Belaroussi Maamri; 🇫🇷 Boulogne Billancourt, France

Dr Michel Dogneton; 🇫🇷 Boulogne Billancourt, France

Dr KALINDJIAN; 🇫🇷 Issy-les-Moulineaux, France

Dr Christophe Grillon; 🇫🇷 Meaux, France

Dr Locquet André; 🇫🇷 Roncq, France

Dr COUPRIE Claire; 🇫🇷 Paris, France

Dr Brigitte Pacault; 🇫🇷 Boulogne Billancourt, France

Hôpital Robert Ballanger; 🇫🇷 Aulnay sous Bois, France

Dr RONZIER Monique; 🇫🇷 Paris, France