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

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ClinicalTrials.gov Identifier: NCT01721850
Recruitment Status : Recruiting
First Posted : November 6, 2012
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
HiPP GmbH & Co. Vertrieb KG

October 30, 2012
November 6, 2012
December 21, 2017
December 2011
June 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01721850 on ClinicalTrials.gov Archive Site
  • growth parameters [ Time Frame: 90 days ]
    determination of body weight, length, 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: vomiting, 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
  • 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
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Infantile Colic
  • 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
  • Active Comparator: control formula
    infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
    Intervention: Other: control 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
    Intervention: Other: intervention formula 1
  • 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
    Intervention: Other: intervention formula 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
174
Same as current
December 2018
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 60 Days   (Child)
Yes
Contact: Christina Hecht 00498441757855 Christina.hecht@hipp.de
Germany,   Italy
 
 
NCT01721850
HiPP-505092
No
Not Provided
Not Provided
HiPP GmbH & Co. Vertrieb KG
HiPP GmbH & Co. Vertrieb KG
Not Provided
Principal Investigator: Francesco Savino, Dr. Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
HiPP GmbH & Co. Vertrieb KG
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP