Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic (Coco)
Primary Purpose
Infantile Colic
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
control formula
intervention formula 1
intervention formula 2
Sponsored by
About this trial
This is an interventional treatment trial for Infantile Colic focused on measuring infant nutrition, infantile colic
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
Sites / Locations
- Pediatric Office
- Pediatric Office
- Pediatric Office
- Pediatric office
- Pediatric office
- Pediatric office
- Pediatric Office
- Pediatric office
- Pediatric office
- Pediatric office
- Pediatric office
- Pediatric Office
- Pediatric Office
- Pediatric office
- Pediatric office
- Pediatric office
- Pediatric Office
- Pediatric Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
control formula
intervention formula 1 group
intervention formula 2 group
Arm Description
infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
Outcomes
Primary Outcome Measures
daily total crying time
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
determination of body weight, length, head circumference
tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects
stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions
formula intake
evaluation of average daily drinking amount and formula acceptance
intestinal microbiota
evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention
Full Information
NCT ID
NCT01721850
First Posted
October 30, 2012
Last Updated
January 4, 2022
Sponsor
HiPP GmbH & Co. Vertrieb KG
1. Study Identification
Unique Protocol Identification Number
NCT01721850
Brief Title
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
Acronym
Coco
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Trial insurance could not be prolonged any more and expired
Study Start Date
December 2011 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HiPP GmbH & Co. Vertrieb KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic
Keywords
infant nutrition, infantile colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control formula
Arm Type
Active Comparator
Arm Description
infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
Arm Title
intervention formula 1 group
Arm Type
Experimental
Arm Description
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
Arm Title
intervention formula 2 group
Arm Type
Experimental
Arm Description
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
Intervention Type
Other
Intervention Name(s)
control formula
Intervention Description
commercial stage 1 infant formula
Intervention Type
Other
Intervention Name(s)
intervention formula 1
Intervention Description
infant formula with hydrolyzed protein (type I) and pre- and probiotics
Intervention Type
Other
Intervention Name(s)
intervention formula 2
Intervention Description
infant formula with hydrolyzed protein (type II) and pre- and probiotics
Primary Outcome Measure Information:
Title
daily total crying time
Description
evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group
Time Frame
28 days
Secondary Outcome Measure Information:
Title
growth parameters
Description
determination of body weight, length, head circumference
Time Frame
90 days
Title
tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects
Description
stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions
Time Frame
28 days
Title
formula intake
Description
evaluation of average daily drinking amount and formula acceptance
Time Frame
28 days
Title
intestinal microbiota
Description
evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention
Time Frame
0-28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Days
Maximum Age & Unit of Time
60 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Savino, Dr.
Organizational Affiliation
Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Office
City
Düsseldorf
ZIP/Postal Code
40223
Country
Germany
Facility Name
Pediatric Office
City
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
Pediatric Office
City
Mülheim an der Ruhr
ZIP/Postal Code
45475
Country
Germany
Facility Name
Pediatric office
City
Alba
State/Province
Piemonte
ZIP/Postal Code
10141
Country
Italy
Facility Name
Pediatric office
City
Borgone
State/Province
Piemonte
ZIP/Postal Code
10053
Country
Italy
Facility Name
Pediatric office
City
Carmagnola
State/Province
Piemonte
ZIP/Postal Code
10022
Country
Italy
Facility Name
Pediatric Office
City
Condove
State/Province
Piemonte
ZIP/Postal Code
10055
Country
Italy
Facility Name
Pediatric office
City
Mondovi
State/Province
Piemonte
ZIP/Postal Code
10090
Country
Italy
Facility Name
Pediatric office
City
San Mauro Torinese
State/Province
Piemonte
ZIP/Postal Code
10099
Country
Italy
Facility Name
Pediatric office
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10124
Country
Italy
Facility Name
Pediatric office
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Pediatric Office
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10132
Country
Italy
Facility Name
Pediatric Office
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10137
Country
Italy
Facility Name
Pediatric office
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10148
Country
Italy
Facility Name
Pediatric office
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10149
Country
Italy
Facility Name
Pediatric office
City
Turin
State/Province
Piemonte
ZIP/Postal Code
10078
Country
Italy
Facility Name
Pediatric Office
City
Volpiano
State/Province
Piemonte
ZIP/Postal Code
10088
Country
Italy
Facility Name
Pediatric Office
City
Volvera
State/Province
Piemonte
ZIP/Postal Code
10040
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
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