An Infant Formula Trial on Dietary Management of Infantile Colic

Not Applicable

Terminated

• Conditions: Infantile Colic
• Interventions: Other: Specific hydrolysed proteins; Other: Standard cow's milk with prebiotics mixture

• Registration Number: NCT03329222
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

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)

Study Timeline

• Study First Submitted: 2017-10-03
• Study Start: 2017-10-27
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-01
• Primary Completion: 2018-07-03
• Study Completion: 2018-07-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Specific hydrolysed proteins	An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
Control group	Standard cow's milk with prebiotics mixture	Standard cow's milk with prebiotics mixture

Primary Outcome Measures

Name	Time	Method
Daily inconsolable crying time using data recorded on subject's diaries	6 weeks	Daily inconsolable crying time over 6 weeks

Secondary Outcome Measures

Name	Time	Method
Daily crying time using data recorded on subject's diaries	6 weeks	Daily crying time over 6 weeks of intervention
Daily fussing time using data recorded on subject's diaries	6 weeks	Daily fussing 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
Daily stool consistency using data recorded on subject's diaries	6 weeks	Daily stool consistency 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
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

Trial Locations

Locations (2)

National University Hospital, Singapore; 🇸🇬 Singapore, Singapore

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand