Infantile Colic
Conditions
Brief summary
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
Detailed description
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic. The hypothesis of the study is that the test product, compared to the control formula, will reduce the crying time in infants with infantile colic. The various time points of the outcome are: V1 (screening : Day -5 to day 0); V2 ( Randomization: Day 0); V3 (Day 7); V4 (Day 21); Phone Call (Day 28); V5 (End -intervention: Day 42); V6 (Day 56)
Interventions
OTHERSpecific hydrolysed proteins
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
OTHERStandard cow's milk with prebiotics mixture
Standard cow's milk with prebiotics mixture
Sponsors
National University Hospital, Singapore
Phramongkutklao College of Medicine and Hospital
Maharaj Nakorn Chiang Mai Hospital
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Randomized, two arms
Eligibility
Sex/Gender
ALL
Age
21 Days to 56 Days
Healthy volunteers
No
Inclusion criteria
1. Infants aged 21-56 days (both inclusive); 2. Gestation age 37-42 weeks; 3. Normal birth weight for gestational age and gender 4. 5-minute APGAR score \>7; 5. Diagnosed with infantile colic ; 6. Fully formula fed for at least 7 days before randomisation; 7. Written informed consent from the parent and/or legal representative.
Exclusion criteria
1. Any plausible cause of inconsolable crying as judged by the investigator; 2. Presence of non-functional vomiting or failure to thrive; 3. Presence of any congenital defects in the gastrointestinal system or other defects preventing oral nutrition; 4. Congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes; 5. Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations; 6. Received any special formula (e.g. lactose-free, hydrolysed protein); 7. Received any of the following products/medication within 7 days before randomisation: 1. Probiotics 2. Systemic antibiotics 3. Prokinetics 4. Proton pump inhibitors 8. Twins or triplets or other infant(s) \<6 months of age living in the same household; 9. Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; 10. Current participation in another clinical study involving investigational or marketed products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily inconsolable crying time using data recorded on subject's diaries | 6 weeks | Daily inconsolable crying time over 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily fussing time using data recorded on subject's diaries | 6 weeks | Daily fussing time over 6 weeks of intervention |
| Daily inconsolable fussing time using data recorded on subject's diaries | 6 weeks | Daily inconsolable fussing time over 6 weeks of intervention |
| Daily stool frequency using data recorded on subject's diaries | 6 weeks | Daily stool frequency over 6 weeks of intervention |
| Daily crying time using data recorded on subject's diaries | 6 weeks | Daily crying time over 6 weeks of intervention |
| The frequency of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire | 6 weeks | Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period |
| The intensity of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire | 6 weeks | Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period |
| Daily stool consistency using data recorded on subject's diaries | 6 weeks | Daily stool consistency over 6 weeks of intervention |
Countries
Singapore, Thailand
Outcome results
None listed