Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic (Coco)

January 4, 2022 updated by: HiPP GmbH & Co. Vertrieb KG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40223
        • Pediatric Office
      • Kehl, Germany, 77694
        • Pediatric Office
      • Mülheim an der Ruhr, Germany, 45475
        • Pediatric Office
  • Italy
    • Piemonte
      • Alba, Piemonte, Italy, 10141
        • Pediatric Office
      • Borgone, Piemonte, Italy, 10053
        • Pediatric Office
      • Carmagnola, Piemonte, Italy, 10022
        • Pediatric Office
      • Condove, Piemonte, Italy, 10055
        • Pediatric Office
      • Mondovi, Piemonte, Italy, 10090
        • Pediatric Office
      • San Mauro Torinese, Piemonte, Italy, 10099
        • Pediatric Office
      • Torino, Piemonte, Italy, 10124
        • Pediatric Office
      • Torino, Piemonte, Italy, 10126
        • Pediatric Office
      • Torino, Piemonte, Italy, 10132
        • Pediatric Office
      • Torino, Piemonte, Italy, 10137
        • Pediatric Office
      • Torino, Piemonte, Italy, 10148
        • Pediatric Office
      • Torino, Piemonte, Italy, 10149
        • Pediatric Office
      • Turin, Piemonte, Italy, 10078
        • Pediatric Office
      • Volpiano, Piemonte, Italy, 10088
        • Pediatric Office
      • Volvera, Piemonte, Italy, 10040
        • Pediatric Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control formula
infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
Other: control formula
commercial stage 1 infant formula
Experimental: intervention formula 1 group
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
Other: intervention formula 1
infant formula with hydrolyzed protein (type I) and pre- and probiotics
Experimental: intervention formula 2 group
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
Other: intervention formula 2
infant formula with hydrolyzed protein (type II) and pre- and probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
growth parameters
Time Frame: 90 days
determination of body weight, length, head circumference
90 days
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: vomiting, diarrhea, skin reactions
28 days
formula intake
Time Frame: 28 days
evaluation of average daily drinking amount and formula acceptance
28 days
intestinal microbiota
Time Frame: 0-28 days
evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention
0-28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HiPP GmbH & Co. Vertrieb KG

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiPP-505092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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