Skip to main content
OpenTrials
Completed

NCT Number: NCT00929292

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Growth Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

3 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr Francine Gressin-Cohen, Antony, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modilac Dahlia 1

Other

Infant formula used for non breastfed children with colic

Other names: Dahlia

Modilac 1

Other

Infant formula used for non breastfed children

Other names: Modilac

Primary outcomes

  1. Crying duration per 24 hours

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

Secondary outcomes

  1. Growth Parameters

    Time frame: Day 30

  2. Clinical Tolerance

    Time frame: 3 days before days 15 and 30

  3. 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

  4. Number of regurgitations per day

    Time frame: 3 days before days 15 and 30

  5. Gas and abdominal distensions

    Time frame: 3 days before days 15 and 30

  6. Necessary Additive treatments

    Time frame: 3 days before days 15 and 30

  7. Parents' satisfaction

    Time frame: Days 15 and 30

  8. Agitation/Restlessness Period Duration

    Time frame: 3 days before days 15 and 30

Sponsors and collaborators

Lead sponsor

Sodilac

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 29, 2009
Registry last updated
Jun 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.