An Infant Formula Trial on Dietary Management of Infantile Colic

NCT03329222 | Terminated

• 1 other identifier: EBB16SI06749
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 2

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.

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (1)

• Daily inconsolable crying time using data recorded on subject's diaries

  Daily inconsolable crying time over 6 weeks

  6 weeks

Secondary Outcomes (7)

• Daily crying time using data recorded on subject's diaries

  6 weeks

• Daily fussing time using data recorded on subject's diaries

  6 weeks

• Daily inconsolable fussing time using data recorded on subject's diaries

  6 weeks

• Daily stool frequency using data recorded on subject's diaries

  6 weeks

• Daily stool consistency using data recorded on subject's diaries

  6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Specific hydrolysed proteins

Control group

ACTIVE COMPARATOR

Standard cow's milk with prebiotics mixture

Other: Standard cow's milk with prebiotics mixture

Interventions

Specific hydrolysed proteins OTHER

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

Intervention group

Standard cow's milk with prebiotics mixture OTHER

Standard cow's milk with prebiotics mixture

Control group

Eligibility Criteria

• Age: 21 Days - 56 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 21-56 days (both inclusive);
• Gestation age 37-42 weeks;
• Normal birth weight for gestational age and gender
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

National University Hospital, Singapore

Singapore, 119228, Singapore

Location

Phramongkutklao Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, two arms

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: November 1, 2017
• Study Start: October 27, 2017
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); TH (1)