An Infant Formula Trial on Dietary Management of Infantile Colic

A Randomised, Double Blind, Controlled, Multi-centre Study to Assess the Efficacy of an Infant Formula in the Dietary Management of Infantile Colic

A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.

Study Overview

• Status: Terminated
• Conditions: Infantile Colic
• Intervention / Treatment: Other: Specific hydrolysed proteins; Other: Standard cow's milk with prebiotics mixture

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital, Singapore
• Thailand
  • Bangkok, Thailand
    • Phramongkutklao Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose	Other: Specific hydrolysed proteins; An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
Active Comparator: Control group; Standard cow's milk with prebiotics mixture	Other: Standard cow's milk with prebiotics mixture; Standard cow's milk with prebiotics mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily inconsolable crying time using data recorded on subject's diaries	Daily inconsolable crying time over 6 weeks	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily crying time using data recorded on subject's diaries	Daily crying time over 6 weeks of intervention	6 weeks
Daily fussing time using data recorded on subject's diaries	Daily fussing time over 6 weeks of intervention	6 weeks
Daily inconsolable fussing time using data recorded on subject's diaries	Daily inconsolable fussing time over 6 weeks of intervention	6 weeks
Daily stool frequency using data recorded on subject's diaries	Daily stool frequency over 6 weeks of intervention	6 weeks
Daily stool consistency using data recorded on subject's diaries	Daily stool consistency over 6 weeks of intervention	6 weeks
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	6 weeks
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	6 weeks

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: National University Hospital, Singapore; Phramongkutklao College of Medicine and Hospital; Maharaj Nakorn Chiang Mai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): July 3, 2018

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: EBB16SI06749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No