| Trial name or title |
Title: Evaluation of safety and efficacy of new infant formula in infantile colic (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, randomised, controlled intervention study |
| Methods |
Double‐blind, randomised‐controlled intervention study |
| Participants |
Inclusion criteria
Healthy, term infants Participants appropriate for gestational age, between 35 and 41 weeks Participants between 15 and 60 days old Participants with birth weight between 2500 g and 4200 g, and with regular weight gain (≥ 150 g/week) Diagnosis of infantile colic according to modified Wessel criteria (crying episodes lasting ≥ 3 h/d and occurring ≥ 3 d/week for at least 1 week) Participants exclusively formula‐fed at study entrance Day care of the child only by mother or father or both Provide written informed consent in accordance with legal requirement
Exclusion criteria
Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, necrotising entercolitis) Clinical evidence of chronic illness or gastrointestinal disorders (gastroesophageal reflux, 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 Participants receiving formula for special medical purposes Exclusively breastfed infants Feeding of supplemental probiotics or prebiotics (or both) 2 weeks prior to inclusion Allergic diseases (manifest atopic dermatitis, cows' milk allergy) Participation in any other clinical intervention
|
| Interventions |
Parallel assignment with 3 arms:
control formula (standard formula) intervention formula 1 (infant formula with hydrolysed protein (type I) and pre‐ and probiotics intervention formula 2 (infant formula with hydrolysed protein (type II) and pre‐ and probiotics
|
| Outcomes |
Primary outcome
Daily total crying time (time frame: 28 days); evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between the intervention and control groups
Secondary outcomes
Growth parameters (time frame: 90 days); determination of body weight, length, head circumference Tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects (time frame: 28 days); stool characteristics: frequency, consistency and colour; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhoea, skin reactions Formula intake (time frame: 28 days); evaluation of average daily drinking amount and formula acceptance Intestinal microbiota (time frame: 0 to 28 days); evaluation of changes in the composition of the intestinal microbiota (lactobacilli, bifidobacteria, coliforms) after intervention
|
| Starting date |
December 2011 |
| Contact information |
Name: Christina Hecht
Email: Christina.hecht@hipp.de
Telephone: 00498441757855 |
| Notes |
Status: recruiting
Funding source: HiPP GmbH & Co. Vertrieb KG |
