NCT06268964 Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
| NCT ID | NCT06268964 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Universidad de Colima |
| Condition | Functional Abdominal Pain Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 82 participants in total. It began in 2024-09-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks. Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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.
Contact & Investigator
Pablo H Sandoval-Villaseñor, MD
PRINCIPAL INVESTIGATOR
Universidad de Colima
Frequently Asked Questions
Who can join the NCT06268964 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Functional Abdominal Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06268964 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06268964 currently recruiting?
Yes, NCT06268964 is actively recruiting participants. Contact the research team at pablohernan_sandoval@ucol.mx for enrollment information.
Where is the NCT06268964 trial being conducted?
This trial is being conducted at Colima, Mexico.
Who is sponsoring the NCT06268964 clinical trial?
NCT06268964 is sponsored by Universidad de Colima. The principal investigator is Pablo H Sandoval-Villaseñor, MD at Universidad de Colima. The trial plans to enroll 82 participants.