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

Completed · Not applicable

Conditions studied: Common Infant Feeding Problems

In brief

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.

Key facts

Study ID

NCT01934257

Run by

Mead Johnson Nutrition

People needed

296

Starts

1994-06-01

Expected to finish

1996-06-01

Last updated by the study team

2013-09-04

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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