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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01721850

Acronym

Coco

Enrollment

169

Registered

2012-11-06

Start date

2011-12-31

Completion date

2019-04-30

Last updated

2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Colic

Keywords

infant nutrition, infantile colic

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.

Interventions

OTHERcontrol formula

commercial stage 1 infant formula

OTHERintervention formula 1

infant formula with hydrolyzed protein (type I) and pre- and probiotics

OTHERintervention formula 2

infant formula with hydrolyzed protein (type II) and pre- and probiotics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Days to 60 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
formula intake	28 days	evaluation of average daily drinking amount and formula acceptance
intestinal microbiota	0-28 days	evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention

Countries

Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026