An Infant Formula Trial on Dietary Management of Infantile Colic

Danone

Status: Terminated

Conditions: Infantile Colic

Treatments: Other: Standard cow's milk with prebiotics mixture; Other: Specific hydrolysed proteins

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03329222

EBB16SI06749

Details and patient eligibility

About

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

Full 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)

Enrollment: 5 patients

Sex: All

Ages: 21 to 56 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Other: Specific hydrolysed proteins

Control group

Active Comparator group

Description:

Standard cow's milk with prebiotics mixture

Treatment:

Other: Standard cow's milk with prebiotics mixture