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

This study is currently recruiting participants.
Verified November 2012 by HiPP GmbH & Co.
Sponsor:
Information provided by (Responsible Party):
HiPP GmbH & Co.
ClinicalTrials.gov Identifier:
NCT01721850
First received: October 30, 2012
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Infantile Colic
Other: control formula
Other: intervention formula 1
Other: intervention formula 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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, Controlled Intervention Study

Resource links provided by NLM:


Further study details as provided by HiPP GmbH & Co.:

Primary Outcome Measures:
  • daily total crying time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group


Secondary Outcome Measures:
  • growth parameters [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    determination of body weight, lenght, head circumference

  • tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomitting, diarrhea, skin reactions

  • formula intake [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    evaluation of average daily drinking amount and formula acceptance

  • intestinal microbiota [ Time Frame: 0-28 days ] [ Designated as safety issue: No ]
    evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention


Estimated Enrollment: 174
Study Start Date: December 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 50 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy term infants
  • Subjects appropriate for gestational age between 37 and 41 weeks
  • Subjects between 15-50 days old
  • Subjects with birth weight between 2500 and 4000 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721850

Contacts
Contact: Claudia Steiner, Dr 00498441757523 Claudia.Steiner@hipp.de

Locations
Italy
Pediatric office Recruiting
Carmagnola, Piemonte, Italy, 10022
Contact: Pietro Lerro, Dr.         
Pediatric office Recruiting
Grugliasco, Piemonte, Italy, 10095
Contact: Amalia Peltran, Dr.         
Pediatric office Recruiting
Racconigi, Piemonte, Italy, 12035
Contact: Martina Costamagna, Dr.         
Pediatric office Recruiting
Rivoli, Piemonte, Italy, 10090
Contact: Eleonora Bruno, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10124
Contact: Monica M Bianco, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10148
Contact: Emanuela Malorgio, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10147
Contact: Marco Fonsati, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10126
Contact: Massimo Landi, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10126
Contact: Anna M Liatti, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10141
Contact: Elena Tempesta, Dr.         
Pediatric office Recruiting
Venaria, Piemonte, Italy, 10078
Contact: Filomena C Martino, Dr.         
Sponsors and Collaborators
HiPP GmbH & Co.
Investigators
Principal Investigator: Francesco Savino, Dr. Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
  More Information

No publications provided

Responsible Party: HiPP GmbH & Co.
ClinicalTrials.gov Identifier: NCT01721850     History of Changes
Other Study ID Numbers: HiPP-505092
Study First Received: October 30, 2012
Last Updated: November 2, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by HiPP GmbH & Co.:
infant nutrition, infantile colic

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on April 17, 2014