Study Stopped
Trial insurance could not be prolonged any more and expired
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
Coco
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
1 other identifier
interventional
169
2 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 30, 2012
CompletedFirst Posted
Study publicly available on registry
November 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJanuary 20, 2022
January 1, 2022
7.3 years
October 30, 2012
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
28 days
Secondary Outcomes (4)
growth parameters
90 days
tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects
28 days
formula intake
28 days
intestinal microbiota
0-28 days
Study Arms (3)
control formula
ACTIVE COMPARATORinfants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
intervention formula 1 group
EXPERIMENTALinfants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
intervention formula 2 group
EXPERIMENTALinfants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
Interventions
infant formula with hydrolyzed protein (type I) and pre- and probiotics
infant formula with hydrolyzed protein (type II) and pre- and probiotics
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Allergic diseases (manifest atopic dermatitis, cow's milk allergy)
- Participation in any other clinical intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Pediatric Office
Düsseldorf, 40223, Germany
Pediatric Office
Kehl, 77694, Germany
Pediatric Office
Mülheim, 45475, Germany
Pediatric office
Alba, Piedmont, 10141, Italy
Pediatric office
Borgone, Piedmont, 10053, Italy
Pediatric office
Carmagnola, Piedmont, 10022, Italy
Pediatric Office
Condove, Piedmont, 10055, Italy
Pediatric office
Mondovì, Piedmont, 10090, Italy
Pediatric office
San Mauro Torinese, Piedmont, 10099, Italy
Pediatric office
Turin, Piedmont, 10078, Italy
Pediatric office
Turin, Piedmont, 10124, Italy
Pediatric office
Turin, Piedmont, 10126, Italy
Pediatric Office
Turin, Piedmont, 10132, Italy
Pediatric Office
Turin, Piedmont, 10137, Italy
Pediatric office
Turin, Piedmont, 10148, Italy
Pediatric office
Turin, Piedmont, 10149, Italy
Pediatric Office
Volpiano, Piedmont, 10088, Italy
Pediatric Office
Volvera, Piedmont, 10040, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Savino, Dr.
Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2012
First Posted
November 6, 2012
Study Start
December 1, 2011
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
January 20, 2022
Record last verified: 2022-01