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OpenTrials
Completed

NCT Number: NCT01934257

The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems

This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.

Completed

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Key information

Conditions

Common Infant Feeding Problems

Age range

2 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. David Conner, Winnipeg, Manitoba, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is between 2 and 12 weeks of age
  • Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet
  • Subject has never switched to any lactose free formula
  • The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age
  • The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea
  • Signed Informed Consent

Exclusion criteria

  • Subject is in daycare for more than 4 hours per day (20 hours per week)
  • Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding
  • The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment
  • Subject has acute infectious diarrhea or any other intercurrent illness

Treatment and study plan

Marketed milk-based lactose-containing infant formula

Other

Marketed milk-based lactose-free infant formula

Other

Marketed soy-based lactose-free infant formula

Other

Primary outcomes

  1. Early Infant Temperament Questionnaire

    Time frame: 14 days

Secondary outcomes

  1. Infant Characteristic Questionnaire

    Time frame: 14 days

  2. Maternal Efficacy Questionnaire

    Time frame: 14 days

  3. Mental Health Inventory Questionnaire

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
1994
Primary completion
1996
Study completion
1996
First posted
Sep 4, 2013
Registry last updated
Sep 4, 2013

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.