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

NCT06268964 | Recruiting Phase 1 DMC

• 1 other identifier: 2023-5
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improvement in Quality of Life with PedsQL 3.0

  Baseline to 8 weeks post-treatment.

• Improvement in Quality of Life with PedsQL 3.0

  Baseline to 4 weeks post-treatment.

• Average Score on Visual Analog Scale for Abdominal Pain

  Baseline to 4 weeks post-treatment.

Other Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events

  Baseline to 8 weeks post-treatment.

Study Arms (3)

Trimebutine + Probiotic

EXPERIMENTAL

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; Dietary Supplement: Lactobacillus rhamnosus

Trimebutine + Placebo

ACTIVE COMPARATOR

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; Other: Placebo

Probiotic + Placebo

ACTIVE COMPARATOR

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; Other: Placebo

Interventions

Trimebutine DRUG

Prescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.

Trimebutine + Placebo; Trimebutine + Probiotic

Lactobacillus rhamnosus DIETARY_SUPPLEMENT

Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.

Probiotic + Placebo; Trimebutine + Probiotic

Placebo OTHER

Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.

Also known as: Microcrystalline cellulose

Probiotic + Placebo; Trimebutine + Placebo

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Colima: lead

Study Sites (1)

School of Medicine, University of Colima

Colima, 28040, Mexico

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Trimebutine; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydroxybenzoate Ethers; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Pablo H Sandoval-Villaseñor, MD

  Universidad de Colima

  PRINCIPAL INVESTIGATOR

• Fabián Rojas-Larios, PhD

  Universidad de Colima

  STUDY DIRECTOR

• Carmen A Sánchez-Ramírez, PhD

  Universidad de Colima

  STUDY DIRECTOR

Central Study Contacts

Pablo H Sandoval-Villaseñor, MD

CONTACT

+523123007655; pablohernan_sandoval@ucol.mx

Fabián Rojas-Larios, PhD

CONTACT

+523121206804; frojas@ucol.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Science

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 21, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)