Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Medical College of Wisconsin
- Locations
- 1
- Primary Endpoint
- Anxiety Affects
Study Overview
Brief Summary
IND application was submitted to FDA on November 17th.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Melatonin, Peppermint Oil, Simethicone
Intervention: Melatonin, Peppermint Oil (mentharil), and Simethicone (Drug)
Sugar pill
Intervention: Sugar pill (Other)
Outcomes
Primary Outcomes
Anxiety Affects
Time Frame: 8 weeks
To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.
Quality of Life
Time Frame: 8 weeks
To evaluate improvement in quality of life in children treated with combination therapy versus placebo.
Pain Reduction
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported