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

Astel Medica68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colic

Interventions

Bactecal® D LiquidDIETARY_SUPPLEMENT

The patients will be randomized into two arms, A and B, in function of the intervention dose

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 8 Weeks

Medical Language ↔ Plain English

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 %

Locations (1)

UZ Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

Change in parent quality of life (QoL) score

By measuring parent quality of Life (QoL) score. Scale from 1 (minimum) to 7 (maximum). Higher scores mean a better outcome.

Time frame: Change from baseline parent QoL score at 28 days

Secondary Outcomes

Change of daily median crying time

By measuring the mean change in crying time

Time frame: Change from baseline daily median crying time at 28 days

Change of the number of crying

By measuring the numbers per day

Time frame: Change from baseline number of crying at 28 days

Data from ClinicalTrials.gov

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