Back to resultsAn Infant Formula Trial on Dietary Management of Infantile Colic
Primary Purpose
Infantile Colic
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Specific hydrolysed proteins
Standard cow's milk with prebiotics mixture
Sponsored by
About this trial
This is an interventional other trial for Infantile Colic
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- National University Hospital, Singapore
- Phramongkutklao Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
Standard cow's milk with prebiotics mixture
Outcomes
Primary Outcome Measures
Daily inconsolable crying time using data recorded on subject's diaries
Daily inconsolable crying time over 6 weeks
Secondary Outcome Measures
Daily crying time using data recorded on subject's diaries
Daily crying time over 6 weeks of intervention
Daily fussing time using data recorded on subject's diaries
Daily fussing time over 6 weeks of intervention
Daily inconsolable fussing time using data recorded on subject's diaries
Daily inconsolable fussing time over 6 weeks of intervention
Daily stool frequency using data recorded on subject's diaries
Daily stool frequency over 6 weeks of intervention
Daily stool consistency using data recorded on subject's diaries
Daily stool consistency 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
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
Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period
Full Information
NCT ID
NCT03329222
First Posted
October 3, 2017
Last Updated
September 7, 2018
Sponsor
Danone Asia Pacific Holdings Pte, Ltd.
Collaborators
National University Hospital, Singapore, Phramongkutklao College of Medicine and Hospital, Maharaj Nakorn Chiang Mai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03329222
Brief Title
An Infant Formula Trial on Dietary Management of Infantile Colic
Official Title
A Randomised, Double Blind, Controlled, Multi-centre Study to Assess the Efficacy of an Infant Formula in the Dietary Management of Infantile Colic
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
July 3, 2018 (Actual)
Study Completion Date
July 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Asia Pacific Holdings Pte, Ltd.
Collaborators
National University Hospital, Singapore, Phramongkutklao College of Medicine and Hospital, Maharaj Nakorn Chiang Mai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, two arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard cow's milk with prebiotics mixture
Intervention Type
Other
Intervention Name(s)
Specific hydrolysed proteins
Intervention Description
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
Intervention Type
Other
Intervention Name(s)
Standard cow's milk with prebiotics mixture
Intervention Description
Standard cow's milk with prebiotics mixture
Primary Outcome Measure Information:
Title
Daily inconsolable crying time using data recorded on subject's diaries
Description
Daily inconsolable crying time over 6 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Daily crying time using data recorded on subject's diaries
Description
Daily crying time over 6 weeks of intervention
Time Frame
6 weeks
Title
Daily fussing time using data recorded on subject's diaries
Description
Daily fussing time over 6 weeks of intervention
Time Frame
6 weeks
Title
Daily inconsolable fussing time using data recorded on subject's diaries
Description
Daily inconsolable fussing time over 6 weeks of intervention
Time Frame
6 weeks
Title
Daily stool frequency using data recorded on subject's diaries
Description
Daily stool frequency over 6 weeks of intervention
Time Frame
6 weeks
Title
Daily stool consistency using data recorded on subject's diaries
Description
Daily stool consistency over 6 weeks of intervention
Time Frame
6 weeks
Title
The frequency of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
Description
Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period
Time Frame
6 weeks
Title
The intensity of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
Description
Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Days
Maximum Age & Unit of Time
56 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
National University Hospital, Singapore
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Phramongkutklao Hospital
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Infant Formula Trial on Dietary Management of Infantile Colic
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