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Compares treatment options for Functional Abdominal Pain Syndrome
Official title Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
ClinicalTrials.gov ID: NCT06268964
What this study is testing
What is Trimebutine?
Trimebutine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for functional abdominal pain syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children?
- Phase 2: a mid-size study of how well it works
- 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 4 to 18. Healthy volunteers may be eligible.
You may be able to join if
- Pediatric patients from 4 to 18 years old.
- Meeting the Rome IV criteria for any of the Functional Abdominal Pain Disorders (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine...
- Having the informed consent signed by the parents or legal guardians of the minor.
You likely can't join if
- Patients presenting abdominal pain of organic cause.
- Immunosuppressed patients.
- Patients with previous hypersensitivity to the study drug. Elimination Criteria:
- Voluntary withdrawal from the study.
- Patients not adhering to treatment (less than 80%)
- Patients participating in another study simultaneously.
See the full eligibility criteria
- Pediatric patients from 4 to 18 years old.
- Meeting the Rome IV criteria for any of the Functional Abdominal Pain Disorders (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine or Functional Abdominal Pain Not Otherwise Specified)
- Having the informed consent signed by the parents or legal guardians of the minor.
- Patients presenting abdominal pain of organic cause.
- Immunosuppressed patients.
- Patients with previous hypersensitivity to the study drug. Elimination Criteria:
- Voluntary withdrawal from the study.
- Patients not adhering to treatment (less than 80%)
- Patients participating in another study simultaneously.
- Patients being treated by another doctor simultaneously.
The study team makes the final eligibility decision.
Where it's taking place
- Colima, Mexico
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 - 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, 4 years to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colima, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.