An Infant Formula Trial on Dietary Management of Infantile Colic

Infantile Colic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03329222
• Other study ID #: EBB16SI06749
• Status: Terminated
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: July 3, 2018

Study information

• Verified date: September 2018
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 3, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 56 Days

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Other:
• Specific hydrolysed proteins
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
• Standard cow's milk with prebiotics mixture
Standard cow's milk with prebiotics mixture

Locations

Country	Name	City	State
Singapore	National University Hospital, Singapore	Singapore
Thailand	Phramongkutklao Hospital	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.	Maharaj Nakorn Chiang Mai Hospital, National University Hospital, Singapore, Phramongkutklao College of Medicine and Hospital

Countries where clinical trial is conducted

Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily inconsolable crying time using data recorded on subject's diaries	Daily inconsolable crying time over 6 weeks	6 weeks
Secondary	Daily crying time using data recorded on subject's diaries	Daily crying time over 6 weeks of intervention	6 weeks
Secondary	Daily fussing time using data recorded on subject's diaries	Daily fussing time over 6 weeks of intervention	6 weeks
Secondary	Daily inconsolable fussing time using data recorded on subject's diaries	Daily inconsolable fussing time over 6 weeks of intervention	6 weeks
Secondary	Daily stool frequency using data recorded on subject's diaries	Daily stool frequency over 6 weeks of intervention	6 weeks
Secondary	Daily stool consistency using data recorded on subject's diaries	Daily stool consistency over 6 weeks of intervention	6 weeks
Secondary	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
Secondary	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