Clinical Trial: Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized,

Brief Summary:

The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.

Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.


Detailed Summary:
Sponsor: HiPP GmbH & Co.

Current Primary Outcome: daily total crying time [ Time Frame: 28 days ]

evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • growth parameters [ Time Frame: 90 days ]
    determination of body weight, lenght, head circumference
  • tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects [ Time Frame: 28 days ]
    stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomitting, diarrhea, skin reactions
  • formula intake [ Time Frame: 28 days ]
    evaluation of average daily drinking amount and formula acceptance
  • intestinal microbiota [ Time Frame: 0-28 days ]
    evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention


Original Secondary Outcome: Same as current

Information By: HiPP GmbH & Co.

Dates:
Date Received: October 30, 2012
Date Started: December 2011
Date Completion: December 2017
Last Updated: May 13, 2016
Last Verified: May 2016