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Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic

NCT01721850 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2022-01-20

No results posted yet for this study

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.

Conditions

  • Infantile Colic

Interventions

OTHER

control formula

commercial stage 1 infant formula

OTHER

intervention formula 1

infant formula with hydrolyzed protein (type I) and pre- and probiotics

OTHER

intervention formula 2

infant formula with hydrolyzed protein (type II) and pre- and probiotics

Sponsors & Collaborators

  • HiPP GmbH & Co. Vertrieb KG

    lead INDUSTRY

Principal Investigators

  • Francesco Savino, Dr. · Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Days
Max Age
60 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01721850 on ClinicalTrials.gov