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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00929292
• Date of registration: 26/06/2009
• Prospective Registration: No
• Primary sponsor: Sodilac
• Public title: Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
• Scientific title: Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.
• Date of first enrolment: November 2006
• Target sample size: 66
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00929292
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Christophe Dupont, PhD
• Affiliation: Hôpital Saint Vincent de Paul

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 3 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Colic

Growth

Intervention(s)

Other: Modilac Dahlia 1

Other: Modilac 1

Primary Outcome(s)

Crying duration per 24 hours [Time Frame: 1 day before the first consumption ; 3 days before days 15 and 30]

Secondary Outcome(s)

Agitation/Restlessness Period Duration [Time Frame: 3 days before days 15 and 30]

Clinical Tolerance [Time Frame: 3 days before days 15 and 30]

Growth Parameters [Time Frame: Day 30]

Parents' satisfaction [Time Frame: Days 15 and 30]

Gas and abdominal distensions [Time Frame: 3 days before days 15 and 30]

Necessary Additive treatments [Time Frame: 3 days before days 15 and 30]

Number of regurgitations per day [Time Frame: 3 days before days 15 and 30]

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]

Secondary ID(s)

DAH-CL3-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors