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Completed

NCT Number: NCT05052476

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

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.

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Key information

Conditions

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

Age range

2 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 %

Treatment and study plan

Bactecal® D Liquid

Dietary Supplement

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

Primary outcomes

  1. Change in parent quality of life (QoL) score

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

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

Secondary outcomes

  1. Change of daily median crying time

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

    By measuring the mean change in crying time

  2. Change of the number of crying

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

    By measuring the numbers per day

Sponsors and collaborators

Lead sponsor

Astel Medica

Industry

Registry information

Acronym: BACTECOLIC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2021
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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