An Infant Formula Trial on Dietary Management of Infantile Colic

NCT ID: NCT03329222

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-27
• Study Completion Date: 2018-07-03

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)

Conditions

Infantile Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose

Group Type: EXPERIMENTAL

Specific hydrolysed proteins

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

Standard cow's milk with prebiotics mixture

Intervention Type: OTHER

Standard cow's milk with prebiotics mixture

Interventions

Specific hydrolysed proteins

An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose

Intervention Type: OTHER

Standard cow's milk with prebiotics mixture

Standard cow's milk with prebiotics mixture

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Days
• Maximum Eligible Age: 56 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role: collaborator

Maharaj Nakorn Chiang Mai Hospital

OTHER

Sponsor Role: collaborator

Danone Asia Pacific Holdings Pte, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital, Singapore

Singapore, , Singapore

Phramongkutklao Hospital

Bangkok, , Thailand

Countries

Singapore; Thailand

Other Identifiers

EBB16SI06749

Identifier Type: -

Identifier Source: org_study_id