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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    60
  • sponsor
    Astel Medica
Updated on 9 May 2022

Summary

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.

Details
Condition Colic
Treatment Bactecal® D Liquid
Clinical Study IdentifierNCT05052476
SponsorAstel Medica
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

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 %
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note