Functional Abdominal Pain, Functional Dyspepsia, Irritable Bowel Syndrome
Conditions
Keywords
Functional Abdominal Pain, Irritable Bowel Syndrome, IBS, Functional Dyspepsia, Melatonin, Simethicone, Peppermint Oil, mentharil, functional bowel disorders, quality of life
Brief summary
IND application was submitted to FDA on November 17th.
Interventions
DRUGMelatonin, Peppermint Oil (mentharil), and Simethicone
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
OTHERSugar pill
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.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | 8 weeks | 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. |
| Quality of Life | 8 weeks | To evaluate improvement in quality of life in children treated with combination therapy versus placebo. |
| Anxiety Affects | 8 weeks | To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders. |
Countries
United States
Outcome results
None listed