First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic (BACTECOLIC)

Astel Medica

Status

Completed

Conditions

Colic

Treatments

Dietary Supplement: Bactecal® D Liquid

Study type

Interventional

Funder types

Industry

Identifiers

NCT05052476

BACTECOLIC

Details and patient eligibility

About

This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics.

The patients will be randomized into two arms, A and B, in function of the intervention dose. The quality of life of te parents as well as the daily median crying time and the number of daily crying will be assessed.

Enrollment

68 patients

Sex

All

Ages

2 to 8 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

Full term healthy infant (37-41 weeks amenorrhea)
Birth weight >2750 g
Aged between 2 and 8 weeks
Presenting symptoms of infant colic as defined by Rome IV criteria by Zeevenhoven et al. 2017
Signed written informed consent of the parent/tutor

Exclusion criteria

Premature birth
Using probiotics as a treatment, different from the one that could contain the formula at the time of study recruitment
Acute or chronic illness as judged by the investigator which avoids the participation to the study .
Parents unable to understand the requirements of study participation as judged by the investigator
Malnutrition as judged by a body weight/height ratio <5 %