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Infantile Colic | Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic

Infantile Colic research study

What is the primary objective of this 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infantile Colic

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:control formulacommercial stage 1 infant formula

Other:intervention formula 1infant formula with hydrolyzed protein (type I) and pre- and probiotics

Other:intervention formula 2infant formula with hydrolyzed protein (type II) and pre- and probiotics

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

intervention formula 1 groupinfants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol

intervention formula 2 groupinfants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol

Study Status

Recruiting

Start Date: December 2011

Completed Date: December 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: daily total crying time

Secondary Outcome: growth parameters

Study sponsors, principal investigator, and references

Principal Investigator: Francesco Savino, Dr.

Lead Sponsor:

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01721850

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