Actively Recruiting
Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
Led by Universidad de Colima · Updated on 2024-08-16
82
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 4 to 18 years
- Diagnosed with Functional Abdominal Pain Disorders according to Rome IV criteria (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine, or Functional Abdominal Pain Not Otherwise Specified)
- Signed informed consent by parents or legal guardians of the minor
You will not qualify if you...
- Abdominal pain of organic cause
- Immunosuppressed patients
- Previous hypersensitivity to the study drug
AI-Screening
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Trial Site Locations
Total: 1 location
1
School of Medicine, University of Colima
Colima, Mexico, 28040
Actively Recruiting
Research Team
P
Pablo H Sandoval-Villaseñor, MD
CONTACT
F
Fabián Rojas-Larios, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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