Clinical trial NCT03329222: 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
Overall status: TERMINATED
Phase: NA
Conditions: Infantile Colic
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: National University Hospital, Singapore
name: Phramongkutklao College of Medicine and Hospital
name: Maharaj Nakorn Chiang Mai Hospital
First posted: 2017-11-01
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 56
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, two arms
Primary purpose: OTHER

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Daily inconsolable crying time using data recorded on subject's diaries
timeFrame: 6 weeks
Secondary outcomes:
measure: Daily crying time using data recorded on subject's diaries
timeFrame: 6 weeks
measure: Daily fussing time using data recorded on subject's diaries
timeFrame: 6 weeks
measure: Daily inconsolable fussing time using data recorded on subject's diaries
timeFrame: 6 weeks
measure: Daily stool frequency using data recorded on subject's diaries
timeFrame: 6 weeks
measure: Daily stool consistency using data recorded on subject's diaries
timeFrame: 6 weeks
measure: The frequency of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
timeFrame: 6 weeks
measure: The intensity of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
References: