The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems
NCT ID: NCT01934257
Last Updated: 2013-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
296 participants
INTERVENTIONAL
1994-06-30
1996-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Marketed milk-based lactose-containing infant formula
Marketed milk-based lactose-containing infant formula
Marketed milk-based lactose-free infant formula
Marketed milk-based lactose-free infant formula
Marketed soy-based lactose-free infant formula
Marketed soy-based lactose-free infant formula
Interventions
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Marketed milk-based lactose-containing infant formula
Marketed milk-based lactose-free infant formula
Marketed soy-based lactose-free infant formula
Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Weeks
12 Weeks
ALL
No
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Colin Rudolph, M.D., Ph.D
Role: STUDY_DIRECTOR
Mead Johnson & Company
Locations
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Dr. Mark Pearlman
Aurora, California, United States
Gould Medical Foundation
Modesto, California, United States
Memorial Medial Center Research
Savannah, Georgia, United States
Welborn Clinic Peds
Evansville, Indiana, United States
Riveria Pediatrics
Indianapolis, Indiana, United States
Kentucky Pediatrics
Bardstown, Kentucky, United States
Kids Med South
Baton Rouge, Louisiana, United States
The Pediatric Group
Princeton, New Jersey, United States
Chapel Hill Pediatrics
Durham, North Carolina, United States
Henderson Pediatrics
Fletcher, North Carolina, United States
Matthews Children Group
Matthews, North Carolina, United States
Capital Pediatrics
Raleigh, North Carolina, United States
Pediatric Medical Associates
Havertown, Pennsylvania, United States
Pennridge Pediatrics
Sellersville, Pennsylvania, United States
Pittsburgh Pediatric Research
Upper Saint Clair, Pennsylvania, United States
Lewis Gale Clinic
Salem, Virginia, United States
Vancouver Clinic
Vancouver, Washington, United States
Rhinelander Medical Center
Rhinelander, Wisconsin, United States
Dr. David Conner
Winnipeg, Manitoba, Canada
Countries
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References
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Sherman AL, Anderson J, Rudolph CD, Walker LS. Lactose-Free Milk or Soy-Based Formulas Do Not Improve Caregivers' Distress or Perceptions of Difficult Infant Behavior. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):119-24. doi: 10.1097/MPG.0000000000000743.
Other Identifiers
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3332-5
Identifier Type: -
Identifier Source: org_study_id