Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
This study has been completed.
Sponsor:
Sodilac
Information provided by:
Sodilac
ClinicalTrials.gov Identifier:
NCT00929292
First received: June 26, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Growth Colic |
Other: Modilac Dahlia 1 Other: Modilac 1 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic. |
Resource links provided by NLM:
Further study details as provided by Sodilac:
Primary Outcome Measures:
- Crying duration per 24 hours [ Time Frame: 1 day before the first consumption ; 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Growth Parameters [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
- Clinical Tolerance [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Number of regurgitations per day [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
- Gas and abdominal distensions [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
- Necessary Additive treatments [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
- Parents' satisfaction [ Time Frame: Days 15 and 30 ] [ Designated as safety issue: No ]
- Agitation/Restlessness Period Duration [ Time Frame: 3 days before days 15 and 30 ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Dahlia
|
|
Placebo Comparator: Modilac 1
Regular milk
|
Other: Modilac 1
Infant formula used for non breastfed children
Other Name: Modilac
|
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.
Eligibility| Ages Eligible for Study: | up to 3 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929292
Locations
| France | |
| Dr Francine Gressin-Cohen | |
| Antony, France, 92160 | |
| Hôpital privé d'Antony | |
| Antony, France, 92166 | |
| Hôpital Robert Ballanger | |
| Aulnay sous Bois, France, 93602 | |
| Dr Brigitte Pacault | |
| Boulogne Billancourt, France, 92100 | |
| Dr Michel Dogneton | |
| Boulogne Billancourt, France, 92100 | |
| Dr Nassira Belaroussi Maamri | |
| Boulogne Billancourt, France, 92100 | |
| Dr KALINDJIAN | |
| Issy-les-Moulineaux, France, 92130 | |
| Groupe Hospitalier de l'Institut Catholique de Lille (GHICL) | |
| Lille, France, 59020 | |
| Dr Christophe Grillon | |
| Meaux, France, 77100 | |
| Dr RONZIER Monique | |
| Paris, France, 75015 | |
| Dr COUPRIE Claire | |
| Paris, France, 75013 | |
| Dr Locquet André | |
| Roncq, France, 59223 | |
Sponsors and Collaborators
Sodilac
Investigators
| Principal Investigator: | Christophe Dupont, PhD | Hôpital Saint Vincent de Paul |
More Information
No publications provided
| Responsible Party: | Pr Christophe Dupont, Hôpital Saint Vincent de Paul |
| ClinicalTrials.gov Identifier: | NCT00929292 History of Changes |
| Other Study ID Numbers: | DAH-CL3-001 |
| Study First Received: | June 26, 2009 |
| Last Updated: | June 26, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Sodilac:
|
Infant formula Alpha-lactalbumin Protein composition Colic Probiotics |
Additional relevant MeSH terms:
|
Colic Abdominal Pain Pain Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on May 16, 2013