Clinical trial NCT06268964: Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
Official title: Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Functional Abdominal Pain Syndrome
Functional Gastrointestinal Disorders
Irritable Bowel Syndrome Variant of Childhood
Keywords: functional abdominal pain
randomized clinical trial
placebo
double-blind
trimebutine
Lactobacillus rhamnosus
pediatrics
Lead sponsor: Universidad de Colima
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 82
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Average Score on Visual Analog Scale for Abdominal Pain
timeFrame: Baseline to 8 weeks post-treatment.
Secondary outcomes:
measure: Improvement in Quality of Life with PedsQL 3.0
timeFrame: Baseline to 8 weeks post-treatment.
measure: Improvement in Quality of Life with PedsQL 3.0
timeFrame: Baseline to 4 weeks post-treatment.
measure: Average Score on Visual Analog Scale for Abdominal Pain
timeFrame: Baseline to 4 weeks post-treatment.
Other outcomes:
measure: Number of Participants with Treatment-Related Adverse Events
timeFrame: Baseline to 8 weeks post-treatment.
Locations:
city: Colima
country: Mexico
facility: School of Medicine, University of Colima
Study officials:
affiliation: Universidad de Colima
name: Pablo H Sandoval-Villaseñor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Colima
name: Fabián Rojas-Larios, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Colima
name: Carmen A Sánchez-Ramírez, PhD
role: STUDY_DIRECTOR
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