Clinical trial for Colic
Official title Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
ClinicalTrials.gov ID: NCT07347743
What this study is testing
- What it's testing
- The study wants to see if a probiotic supplement is safe and helps reduce colic and excessive crying. It also checks if it improves stool quality and gut health.
- Who it's for
- Healthy newborn babies.
- What's involved
- Participants will take a probiotic supplement or a placebo (inactive pill) and have their health and stool samples checked.
- Time commitment
- The study lasts for the first 3 months of the baby's life.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 14. Healthy volunteers may be eligible.
You may be able to join if
- Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
- Infant is healthy at the time of pre-examination.
- Infant is aged between 1 and 14 days old at the time of inclusion.
- Legal guardian(s) are able and willing to follow the study instructions
- Infant is suitable for participation in the study according to the investigator/ study personnel
You likely can't join if
- No legal guardian's command of any local language
- Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e.
- Infant is suffering from congenital or acquired immunodeficiency
- Infant is suffering from an infection at the time of pre-examination or previous 7 days
- Infant is admitted post-partum to the neonatal intensive care unit
- Infant is not suitable for participation in the study according to the study personnel´s opinion
See the full eligibility criteria
- Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
- Infant is healthy at the time of pre-examination.
- Infant is aged between 1 and 14 days old at the time of inclusion.
- Legal guardian(s) are able and willing to follow the study instructions
- Infant is suitable for participation in the study according to the investigator/ study personnel
- Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).
- Informed written consent given by parent / legal guardian
- No legal guardian's command of any local language
- Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)
- Infant is suffering from congenital or acquired immunodeficiency
- Infant is suffering from an infection at the time of pre-examination or previous 7 days
- Infant is admitted post-partum to the neonatal intensive care unit
- Infant is not suitable for participation in the study according to the study personnel´s opinion
The study team makes the final eligibility decision.
Where it is enrolling
- Jette, Brussels Capital, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 14 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Jette, Brussels Capital, Belgium. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.