Epidemiology of pediatric functional abdominal pain disorders: a meta-analysis.
Judith J Korterink, Kay Diederen, Marc A Benninga...
https://pubmed.ncbi.nlm.nih.gov/25992621Actively Recruiting
Phase 1
Phase 2
Age: 4Years - 18Years
All Genders
Healthy Volunteers
ID06268964
Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders in Children: Randomized Clinical Trial
Led by Universidad de Colima · Updated on 2024-08-16
82
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in children aged 4 to 18 years. The trial aims to determine if trimebutine, probiotics, or their combination can reduce symptoms of FAPD, including Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, and Functional Abdominal Pain Not Otherwise Specified. Participants are selected based on Rome IV criteria and are divided into three treatment groups to compare their effects. Participants will be randomly assigned to one of three groups: trimebutine combined with probiotics, probiotics with placebo, or trimebutine with placebo. Trimebutine is given at 15 mg/kg/day divided into two doses, while probiotics consist of Lactobacillus rhamnosus 5 billion CFUs in a single nightly chewable tablet. The placebo is a microcrystalline cellulose tablet taken once nightly. Treatments last for 8 weeks, with patient follow-up at 4 and 8 weeks to evaluate symptom changes. During the study, participants will complete questionnaires based on Rome IV criteria to assess symptoms, and pain intensity will be measured using the Visual Analog Scale (VAS). Quality of life will be evaluated with the PedsQL 4.0 scale. Follow-up visits at 4 and 8 weeks will reassess symptoms and treatment response. Researchers will monitor treatment adherence and remove participants who withdraw, have low adherence, or participate in other studies. The primary outcome is the average pain score change from baseline to 8 weeks.
CONDITIONS
Brief Title
Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
Who Can Participate
Age: 4Years - 18Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 4 to 18 years
- Meeting Rome IV criteria for Functional Abdominal Pain Disorders (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine, or Functional Abdominal Pain Not Otherwise Specified)
- Signed informed consent from parents or legal guardians
You will not qualify if you...
- Abdominal pain caused by an organic disease
- Immunosuppressed patients
- Previous hypersensitivity to trimebutine
- Voluntary withdrawal from the study
- Treatment adherence less than 80%
- Participation in another study simultaneously
- Being treated by another doctor simultaneously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive assigned treatment with trimebutine, probiotics, or placebo for 8 weeks.
Follow-up visits at 4 weeks and 8 weeks (in-person)
Trial Site Locations
Total: 1 location
1
School of Medicine, University of Colima
Colima, Mexico, 28040
Actively Recruiting
Loading map...
Research Team
P
Pablo H Sandoval-Villaseñor, MD
F
Fabián Rojas-Larios, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Cumulative Effects of Psychologic Distress, Visceral Hypersensitivity, and Abnormal Transit on Patient-reported Outcomes in Irritable Bowel Syndrome.
Magnus Simrén, Hans Törnblom, Olafur S Palsson...
https://pubmed.ncbi.nlm.nih.gov/31022401Paediatric functional abdominal pain disorders.
Nikhil Thapar, Marc A Benninga, Michael D Crowell...
https://pubmed.ncbi.nlm.nih.gov/33154368Probiotics for paediatric functional abdominal pain disorders: A rapid review.
Fang Chao Linda Ding, Mohammad Karkhaneh, Liliane Zorzela...
https://pubmed.ncbi.nlm.nih.gov/31528110Systematic review of randomized controlled trials: fiber supplements for abdominal pain-related functional gastrointestinal disorders in childhood.
Andrea Horvath, Piotr Dziechciarz, Hania Szajewska
https://pubmed.ncbi.nlm.nih.gov/22889919Review article: the physiological effects and safety of peppermint oil and its efficacy in irritable bowel syndrome and other functional disorders.
B P Chumpitazi, G L Kearns, R J Shulman
https://pubmed.ncbi.nlm.nih.gov/29372567The Incidence of Irritable Bowel Syndrome in Children Using the Rome III Criteria and the Effect of Trimebutine Treatment.
Gülcan S Karabulut, Omer F Beşer, Ethem Erginöz...
https://pubmed.ncbi.nlm.nih.gov/23350053Probiotics for management of functional abdominal pain disorders in children.
Chris Wallace, Morris Gordon, Vassiliki Sinopoulou...
https://pubmed.ncbi.nlm.nih.gov/36799531Functional Disorders: Children and Adolescents.
Jeffrey S Hyams, Carlo Di Lorenzo, Miguel Saps...
https://pubmed.ncbi.nlm.nih.gov/27144632Management of Pediatric Migraine: Current Therapies.
Marina Khrizman, Ann Pakalnis
https://pubmed.ncbi.nlm.nih.gov/29446795