Functional Gastrointestinal Disorders Clinical Trial
— FAPD_RCTOfficial title:
Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)
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.
Status | Recruiting |
Enrollment | 82 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | School of Medicine, University of Colima | Colima |
Lead Sponsor | Collaborator |
---|---|
Universidad de Colima |
Mexico,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants with Treatment-Related Adverse Events | Number and type of treatment-related adverse events reported during the study period, evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | Baseline to 8 weeks post-treatment. | |
Primary | Average Score on Visual Analog Scale for Abdominal Pain | Participants rated the highest intensity of abdominal pain they experienced during the past eight weeks on a scale of 0 (no pain) to 10 (worst pain imaginable), using an Visual Analog Scale (VAS) scale. A decrease in the score signifies an improvement in symptoms. | Baseline to 8 weeks post-treatment. | |
Secondary | Improvement in Quality of Life with PedsQL 3.0 | Impact of the treatment on the Quality of Life in pediatric patients with FAPD. The PedsQL 0 - 100 scoring system is used, where higher scores indicate better quality of life. The change in scores from baseline to 8 weeks post-treatment is measured. | Baseline to 8 weeks post-treatment. | |
Secondary | Improvement in Quality of Life with PedsQL 3.0 | Impact of the treatment on the Quality of Life in pediatric patients with FAPD. The PedsQL 0 - 100 scoring system is used, where higher scores indicate better quality of life. The change in scores from baseline to 4 weeks post-treatment is measured. | Baseline to 4 weeks post-treatment. | |
Secondary | Average Score on Visual Analog Scale for Abdominal Pain | Participants rated the highest intensity of abdominal pain they experienced during the past eight weeks on a scale of 0 (no pain) to 10 (worst pain imaginable), using an Visual Analog Scale (VAS) scale. A decrease in the score signifies an improvement in symptoms. | Baseline to 4 weeks post-treatment. |
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