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PI has left institution
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IND application was submitted to FDA on November 17th.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin, Peppermint Oil, Simethicone | Experimental |
| |
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin, Peppermint Oil (mentharil), and Simethicone | Drug | 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 |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Miranda, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19038403 | Background | Saps M, Seshadri R, Sztainberg M, Schaffer G, Marshall BM, Di Lorenzo C. A prospective school-based study of abdominal pain and other common somatic complaints in children. J Pediatr. 2009 Mar;154(3):322-6. doi: 10.1016/j.jpeds.2008.09.047. Epub 2008 Nov 28. | |
| 16396860 | Background | Youssef NN, Murphy TG, Langseder AL, Rosh JR. Quality of life for children with functional abdominal pain: a comparison study of patients' and parents' perceptions. Pediatrics. 2006 Jan;117(1):54-9. doi: 10.1542/peds.2005-0114. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| C015424 | peppermint oil |
| D012841 | Simethicone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Sugar pill | Other | 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. |
|
| 19104969 | Background | Schurman JV, Danda CE, Friesen CA, Hyman PE, Simon SD, Cocjin JT. Variations in psychological profile among children with recurrent abdominal pain. J Clin Psychol Med Settings. 2008 Sep;15(3):241-51. doi: 10.1007/s10880-008-9120-0. Epub 2008 Jul 25. |
| 16049263 | Background | White KS, Farrell AD. Anxiety and psychosocial stress as predictors of headache and abdominal pain in urban early adolescents. J Pediatr Psychol. 2006 Jul;31(6):582-96. doi: 10.1093/jpepsy/jsj050. Epub 2005 Jul 27. |
| 19596010 | Background | Saps M, Youssef N, Miranda A, Nurko S, Hyman P, Cocjin J, Di Lorenzo C. Multicenter, randomized, placebo-controlled trial of amitriptyline in children with functional gastrointestinal disorders. Gastroenterology. 2009 Oct;137(4):1261-9. doi: 10.1053/j.gastro.2009.06.060. Epub 2009 Jul 31. |
| 17426465 | Background | Klupinska G, Poplawski T, Drzewoski J, Harasiuk A, Reiter RJ, Blasiak J, Chojnacki J. Therapeutic effect of melatonin in patients with functional dyspepsia. J Clin Gastroenterol. 2007 Mar;41(3):270-4. doi: 10.1097/MCG.0b013e318031457a. |
| 15914575 | Background | Song GH, Leng PH, Gwee KA, Moochhala SM, Ho KY. Melatonin improves abdominal pain in irritable bowel syndrome patients who have sleep disturbances: a randomised, double blind, placebo controlled study. Gut. 2005 Oct;54(10):1402-7. doi: 10.1136/gut.2004.062034. Epub 2005 May 24. |
| 20413219 | Background | Mickle A, Sood M, Zhang Z, Shahmohammadi G, Sengupta JN, Miranda A. Antinociceptive effects of melatonin in a rat model of post-inflammatory visceral hyperalgesia: a centrally mediated process. Pain. 2010 Jun;149(3):555-564. doi: 10.1016/j.pain.2010.03.030. Epub 2010 Apr 21. |
| 11148527 | Background | Kline RM, Kline JJ, Di Palma J, Barbero GJ. Enteric-coated, pH-dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. J Pediatr. 2001 Jan;138(1):125-8. doi: 10.1067/mpd.2001.109606. |
| 9524891 | Background | Voepel-Lewis TD, Malviya S, Burke C, D'Agostino R, Hadden SM, Siewert M, Tait AR. Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants. J Clin Anesth. 1998 Mar;10(2):91-4. doi: 10.1016/s0952-8180(97)00249-3. |
| 10333820 | Background | Kaplan MA, Prior MJ, Ash RR, McKonly KI, Helzner EC, Nelson EB. Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial. Arch Fam Med. 1999 May-Jun;8(3):243-8. doi: 10.1001/archfami.8.3.243. |
| D004066 | Digestive System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D002241 | Carbohydrates |