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

HiPP

Status: Terminated

Conditions: Infantile Colic

Treatments: Other: control formula; Other: intervention formula 1; Other: intervention formula 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01721850

HiPP-505092

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 15 to 60 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 3 patient groups

control formula

Active Comparator group

Description:

infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol

Treatment:

Other: control formula

intervention formula 1 group

Experimental group

Description:

infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol

Treatment:

Other: intervention formula 1

intervention formula 2 group

Experimental group

Description:

infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol

Treatment:

Other: intervention formula 2