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, Controlled Intervention Study

HiPP GmbH & Co. Vertrieb KG2 sites in 1 country169 target enrollmentDecember 2011

ConditionsInfantile Colic

Overview

Phase: N/A
Intervention: Not specified
Conditions: Infantile Colic
Sponsor: HiPP GmbH & Co. Vertrieb KG
Enrollment: 169
Locations: 2
Primary Endpoint: daily total crying time
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

April 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

HiPP GmbH & Co. Vertrieb KG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy term infants
•Subjects appropriate for gestational age between 35 and 41 weeks
•Subjects between 15-60 days old
•Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week)
•Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)
•Subjects exclusively bottle-fed at study entrance
•Day care of the child only by mother/father
•Provide written informed consent in accordance with legal requirement

Exclusion Criteria

•Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)
•Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)
•Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period
•Subjects receiving formula for special medical purposes
•Exclusively breast-fed infants
•Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion
•Allergic diseases (manifest atopic dermatitis, cow's milk allergy)
•Participation in any other clinical intervention

Outcomes

Primary Outcomes

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

Secondary Outcomes

formula intake(28 days)
growth parameters(90 days)
tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects(28 days)
intestinal microbiota(0-28 days)