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.

Study Overview

• Status: Completed
• Conditions: Common Infant Feeding Problems
• Intervention / Treatment: Other: Marketed milk-based lactose-containing infant formula; Other: Marketed milk-based lactose-free infant formula; Other: Marketed soy-based lactose-free infant formula

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Dr. David Conner
• United States
  • California
    • Aurora, California, United States, 80011
      • Dr. Mark Pearlman
    • Modesto, California, United States, 95355
      • Gould Medical Foundation
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Memorial Medial Center Research
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Welborn Clinic Peds
    • Indianapolis, Indiana, United States, 46254
      • Riveria Pediatrics
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatrics
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70820
      • Kids Med South
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • The Pediatric Group
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Chapel Hill Pediatrics
    • Fletcher, North Carolina, United States, 28732
      • Henderson Pediatrics
    • Matthews, North Carolina, United States, 28105
      • Matthews Children Group
    • Raleigh, North Carolina, United States, 27609
      • Capital Pediatrics
  • Pennsylvania
    • Havertown, Pennsylvania, United States, 19083
      • Pediatric Medical Associates
    • Sellersville, Pennsylvania, United States, 18960
      • Pennridge Pediatrics
    • Upper St. Clair, Pennsylvania, United States, 15241
      • Pittsburgh Pediatric Research
  • Virginia
    • Salem, Virginia, United States, 24153
      • Lewis Gale Clinic
  • Washington
    • Vancouver, Washington, United States, 98664
      • Vancouver Clinic
  • Wisconsin
    • Rhinelander, Wisconsin, United States, 54501
      • Rhinelander Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Marketed milk-based lactose-containing infant formula	Other: Marketed milk-based lactose-containing infant formula
Other: Marketed milk-based lactose-free infant formula	Other: Marketed milk-based lactose-free infant formula
Other: Marketed soy-based lactose-free infant formula	Other: Marketed soy-based lactose-free infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Early Infant Temperament Questionnaire	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Infant Characteristic Questionnaire	14 days
Maternal Efficacy Questionnaire	14 days
Mental Health Inventory Questionnaire	14 days

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Investigators: Study Director: Colin Rudolph, M.D., Ph.D, Mead Johnson & Company

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 1994
• Primary Completion (Actual): June 1, 1996
• Study Completion (Actual): June 1, 1996

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (Estimate): September 4, 2013

Study Record Updates

• Last Update Posted (Estimate): September 4, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 3332-5