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

Infantile Colic Clinical Trial

— Coco  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01721850
• Other study ID #: HiPP-505092
• Status: Terminated
• Phase: N/A
• Start date: December 2011
• Est. completion date: April 2019

Study information

• Verified date: January 2022
• Source: HiPP GmbH & Co. Vertrieb KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 169
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Other:
• control formula
commercial stage 1 infant formula
• intervention formula 1
infant formula with hydrolyzed protein (type I) and pre- and probiotics
• intervention formula 2
infant formula with hydrolyzed protein (type II) and pre- and probiotics

Locations

Country	Name	City	State
Germany	Pediatric Office	Düsseldorf
Germany	Pediatric Office	Kehl
Germany	Pediatric Office	Mülheim an der Ruhr
Italy	Pediatric office	Alba	Piemonte
Italy	Pediatric office	Borgone	Piemonte
Italy	Pediatric office	Carmagnola	Piemonte
Italy	Pediatric Office	Condove	Piemonte
Italy	Pediatric office	Mondovi	Piemonte
Italy	Pediatric office	San Mauro Torinese	Piemonte
Italy	Pediatric office	Torino	Piemonte
Italy	Pediatric office	Torino	Piemonte
Italy	Pediatric Office	Torino	Piemonte
Italy	Pediatric Office	Torino	Piemonte
Italy	Pediatric office	Torino	Piemonte
Italy	Pediatric office	Torino	Piemonte
Italy	Pediatric office	Turin	Piemonte
Italy	Pediatric Office	Volpiano	Piemonte
Italy	Pediatric Office	Volvera	Piemonte

Sponsors (1)

Lead Sponsor	Collaborator
HiPP GmbH & Co. Vertrieb KG

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily total crying time	evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group	28 days
Secondary	growth parameters	determination of body weight, length, head circumference	90 days
Secondary	tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects	stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions	28 days
Secondary	formula intake	evaluation of average daily drinking amount and formula acceptance	28 days
Secondary	intestinal microbiota	evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention	0-28 days