Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

Study Overview
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Brief Summary
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IND application was submitted to FDA on November 17th.

Official Title
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Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

Conditions
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Functional Abdominal Pain, Irritable Bowel Syndrome, Functional Dyspepsia

Intervention / Treatment
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* Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone
* Other: Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To participate in this study, the child/teen must be a patient of the FAP Clinic/GI Clinic in the Division of Gastroenterology at the Children's Hospital of Wisconsin, and have a parent or legal guardian who is willing to participate. Children aged 8-18 years will be eligible for inclusion in the study. Exclusion Criteria: Children or parents who are non-English speaking, or parents and/or children with cognitive delay that precludes comprehension and completion of questionnaires will be excluded from participating in this registry.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin, Peppermint Oil, Simethicone<br> | Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone<br>* Dosing will be dependent on patient's age during time of enrollment. Patients 8-12 years of age will receive Melatonin 3mg tab at night, Peppermint oil 1 capsule (0.2ml) 30-60 minutes prior to meal twice daily, and Simethicone 80mg tab 30-60 minutes prior to meal twice daily. Patients 13-18 years of age will receive Melatonin 3mg tab at night, Peppermint oil 2 capsules (0.4ml) 30-60 minutes prior to meal twice daily, and Simethicone tab 125mg 30-60 minutes prior to meal twice daily<br>|
| Placebo Comparator: Sugar pill<br> | Other: Sugar pill<br>* Patients in the placebo group will receive one placebo tab to be taken at night, one placebo capsule to be taken 30-60 minutes prior to meal twice daily, and one placebo tab to be taken 30-60 minutes prior to meal twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | To evaluate the efficacy of the treatment combination of Melatonin, Peppermint Oil, and Simethicone in releiving the symptoms of pain in Irritable Bowel Syndrome, Functional Abdominal Pain, and Functional Dyspepsia compared to treatment outcomes to placebo. | 8 weeks | 
| Quality of Life | To evaluate improvement in quality of life in children treated with combination therapy versus placebo. | 8 weeks | 
| Anxiety Affects | To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Abdominal Pain, Irritable Bowel Syndrome, IBS, Functional Dyspepsia, Melatonin, Simethicone, Peppermint Oil, mentharil, functional bowel disorders, quality of life