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

Not Applicable

Terminated

• Conditions: Infantile Colic
• Interventions: Other: intervention formula 2; Other: control formula; Other: intervention formula 1

• Registration Number: NCT01721850
• Lead Sponsor: HiPP GmbH & Co. Vertrieb KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention formula 2 group	intervention formula 2	infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
control formula	control formula	infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
intervention formula 1 group	intervention formula 1	infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol

Primary Outcome Measures

Name	Time	Method
daily total crying time	28 days	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

Name	Time	Method
formula intake	28 days	evaluation of average daily drinking amount and formula acceptance
growth parameters	90 days	determination of body weight, length, head circumference
tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects	28 days	stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions
intestinal microbiota	0-28 days	evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention

Trial Locations

Locations (2)

Pediatric office; 🇮🇹 Turin, Piemonte, Italy

Pediatric Office; 🇮🇹 Volvera, Piemonte, Italy