Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics (FAPD_RCT)

August 13, 2024 updated by: Fabian Rojas Larios, Universidad de Colima

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The protocol will be submitted for review by the Research Committee and the Ethics Committee of the Regional University Hospital of Colima. Upon receiving approval, a double-blind, placebo-controlled, randomized clinical trial will be carried out, based on CONSORT guidelines. This trial involves the participation of pediatric patients aged 4 to 18.

Patients will be selected from those attending private practice and satisfying Rome IV criteria for any of the Functional Abdominal Pain Disorders (FAPD). Before any intervention takes place, the purpose and procedures of the study will be explained to both the patients and their legal guardians. If they decide to participate, they will be asked to sign an informed consent letter and assent form for minors. Patients will be selected through stratified probabilistic sampling in 4 categories (Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, and Functional Abdominal Pain not otherwise specified (FAP-NOS)) until the desired sample size of 82 participants is reached. Once participants are selected, they will be randomly assigned to one of the three groups: trimebutine/probiotic, probiotic/placebo, or trimebutine/placebo, with each group consisting of at least 20 participants. The initial diagnosis will be carried out using the Rome IV Criteria Questionnaires for pediatric patients, and the intensity of pain will be evaluated using the Visual Analog Scale (VAS) and quality of life with PedsQL 4.0. Patients will be administered the treatment corresponding to their assigned group and will be clinically followed up at 4 and 8 weeks. During these follow-up consultations, the Rome IV Criteria Questionnaires and scales will be reapplied to assess the evolution of the patients' symptoms and their response to treatment. Any patient who requests voluntary withdrawal, those with treatment adherence less than 80%, and those participating in another study or being treated by another physician simultaneously will be removed from the study.

Statistical analysis will be carried out using international Business Machine (IBM®) Statistical Package for the Social Sciences (SPSS®) Statistics 26. Descriptive statistics with measures of central tendency will be used, presenting the results in tables and graphs. To determine whether the data follow a normal distribution, the Kolmogorov-Smirnov and Shapiro-Wilk tests will be applied. Measurements in 3 groups (trimebutine, probiotics, and control) and at 3 times (0, 4, and 8 weeks) will be analyzed. For intervening categorical variables like gender and education, the chi-square test (X2) will be used. For continuous variables like age and BMI, the Mann-Whitney U test will be applied, expecting statistically significant differences with p < 0.05.

If the data follow a normal distribution, repeated measures ANOVA will be used to compare the means of the 3 groups (trimebutine, probiotics, and placebo). McNemar's test or the sign test will be considered as secondary analyses to evaluate changes within each group over time (0, 4, and 8 weeks). If the data do not follow a normal distribution, non-parametric tests like the Friedman test will be employed.

In case of finding a statistically significant difference in repeated measures ANOVA or the Friedman test, post hoc tests will be performed to identify specific differences between groups and times. If necessary, correlation tests like Pearson or Spearman will be used to evaluate relationships between different variables within the study.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fabián Rojas-Larios, PhD
  • Phone Number: +523121206804
  • Email: frojas@ucol.mx

Study Locations

  • Mexico
      • Colima, Mexico, 28040
        • Recruiting
        • School of Medicine, University of Colima
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Carmen A Sánchez-Ramírez, PhD
        • Principal Investigator:
          • Pablo H Sandoval-Villaseñor, MD
        • Sub-Investigator:
          • Fabián Rojas-Larios, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trimebutine + Probiotic
Participants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets, a single dose (night), for a period of 8 weeks.
Drug: Trimebutine
Prescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.
Dietary supplement: Lactobacillus rhamnosus
Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.
Active Comparator: Trimebutine + Placebo
Participants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks.
Drug: Trimebutine
Prescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.
Other: Placebo
Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.
Other Names:
  • Microcrystalline cellulose
Active Comparator: Probiotic + Placebo
Participants received Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks.
Dietary supplement: Lactobacillus rhamnosus
Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.
Other: Placebo
Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.
Other Names:
  • Microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Score on Visual Analog Scale for Abdominal Pain
Time Frame: Baseline to 8 weeks post-treatment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Quality of Life with PedsQL 3.0
Time Frame: Baseline to 8 weeks post-treatment.
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.
Improvement in Quality of Life with PedsQL 3.0
Time Frame: Baseline to 4 weeks post-treatment.
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.
Average Score on Visual Analog Scale for Abdominal Pain
Time Frame: Baseline to 4 weeks post-treatment.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Related Adverse Events
Time Frame: Baseline to 8 weeks post-treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Colima

Investigators

  • Principal Investigator: Pablo H Sandoval-Villaseñor, MD, Universidad de Colima
  • Study Director: Fabián Rojas-Larios, PhD, Universidad de Colima
  • Study Director: Carmen A Sánchez-Ramírez, PhD, Universidad de Colima

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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