Clinical trial NCT01721850: Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
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
Overall status: TERMINATED
Phase: NA
Conditions: Infantile Colic
Keywords: infant nutrition, infantile colic
Lead sponsor: HiPP GmbH & Co. Vertrieb KG
Sponsor class: INDUSTRY
First posted: 2012-11-06
Enrollment: 169
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: daily total crying time
timeFrame: 28 days
Secondary outcomes:
measure: growth parameters
timeFrame: 90 days
measure: tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects
timeFrame: 28 days
measure: formula intake
timeFrame: 28 days
measure: intestinal microbiota
timeFrame: 0-28 days
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Pediatric Office
city: Kehl
country: Germany
facility: Pediatric Office
city: Mülheim an der Ruhr
country: Germany
facility: Pediatric Office
city: Alba
country: Italy
facility: Pediatric office
state: Piemonte
city: Borgone
country: Italy
facility: Pediatric office
state: Piemonte
city: Carmagnola
country: Italy
facility: Pediatric office
state: Piemonte
city: Condove
country: Italy
facility: Pediatric Office
state: Piemonte
city: Mondovi
country: Italy
facility: Pediatric office
state: Piemonte
city: San Mauro Torinese
country: Italy
facility: Pediatric office
state: Piemonte
city: Torino
country: Italy
facility: Pediatric office
state: Piemonte
city: Torino
country: Italy
facility: Pediatric office
state: Piemonte
city: Torino
country: Italy
facility: Pediatric Office
state: Piemonte
city: Torino
country: Italy
facility: Pediatric Office
state: Piemonte
city: Torino
country: Italy
facility: Pediatric office
state: Piemonte
city: Torino
country: Italy
facility: Pediatric office
state: Piemonte
city: Turin
country: Italy
facility: Pediatric office
state: Piemonte
city: Volpiano
country: Italy
facility: Pediatric Office
state: Piemonte
city: Volvera
country: Italy
facility: Pediatric Office
state: Piemonte
Study officials:
affiliation: Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
name: Francesco Savino, Dr.
role: PRINCIPAL_INVESTIGATOR
References: