Status:
TERMINATED
An Infant Formula Trial on Dietary Management of Infantile Colic
Lead Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Collaborating Sponsors:
National University Hospital, Singapore
Phramongkutklao College of Medicine and Hospital
Conditions:
Infantile Colic
Eligibility:
All Genders
21-56 years
Phase:
NA
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 produ...
Eligibility Criteria
Inclusion
- Infants aged 21-56 days (both inclusive);
- Gestation age 37-42 weeks;
- Normal birth weight for gestational age and gender
- 5-minute APGAR score \>7;
- Diagnosed with infantile colic ;
- Fully formula fed for at least 7 days before randomisation;
- Written informed consent from the parent and/or legal representative.
Exclusion
- Any plausible cause of inconsolable crying as judged by the investigator;
- Presence of non-functional vomiting or failure to thrive;
- Presence of any congenital defects in the gastrointestinal system or other defects preventing oral nutrition;
- Congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes;
- Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations;
- Received any special formula (e.g. lactose-free, hydrolysed protein);
- Received any of the following products/medication within 7 days before randomisation:
- Probiotics
- Systemic antibiotics
- Prokinetics
- Proton pump inhibitors
- Twins or triplets or other infant(s) \<6 months of age living in the same household;
- 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;
- Current participation in another clinical study involving investigational or marketed products.
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03329222
Start Date
October 27 2017
End Date
July 3 2018
Last Update
September 10 2018
Active Locations (2)
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1
National University Hospital, Singapore
Singapore, Singapore, 119228
2
Phramongkutklao Hospital
Bangkok, Thailand