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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD113733-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Virginia Commonwealth University | OTHER |
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The purpose of this Phase IIa study is to identify the most effective antibiotic regimen to treat small intestine bacterial overgrowth (SIBO) in impoverished Bangladeshi children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole | Experimental | 14-day oral course |
|
| Trimethoprim-sulfamethoxazole and Metronidazole | Experimental | 14-day oral course |
|
| Amoxicillin-Clavulanate | Experimental | 14-day oral course |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimethoprim-sulfamethoxazole (TMP/SMX) | Drug | 8-10 mg/kg/day divided every 12 hours, with a maximum 160 mg/dose; dosing based on Trimethoprim |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion to Glucose Hydrogen Breath Test (GHBT) Negativity at Day 15 | GHBT negativity will be defined as no breath hydrogen value ≥20 ppm over the patient's baseline during the course of the test. If any breath hydrogen value during the GHBT is >20 ppm over the patient's baseline, the test will be deemed positive. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion to GHBT Negativity at Day 45 | GHBT negativity will be defined as no breath hydrogen value ≥20 ppm over the patient's baseline during the course of the test. If any breath hydrogen value during the GHBT is >20 ppm over the patient's baseline, the test will be deemed positive. | Day 45 |
| Average Glucose Hydrogen Breath Test Area Under the Curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey R Donowitz, MD | Contact | 434-243-8824 | jrd9d@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey R Donowitz, MD | University of Virginia | Principal Investigator |
| Rashidul Haque, MBBS, PhD | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) | Recruiting | Dhaka | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23974062 | Background | Tahan S, Melli LC, Mello CS, Rodrigues MS, Bezerra Filho H, de Morais MB. Effectiveness of trimethoprim-sulfamethoxazole and metronidazole in the treatment of small intestinal bacterial overgrowth in children living in a slum. J Pediatr Gastroenterol Nutr. 2013 Sep;57(3):316-8. doi: 10.1097/MPG.0b013e3182952e93. | |
| 29049893 | Background | Mello CS, Rodrigues MSDC, Filho HBA, Melli LCFL, Tahan S, Pignatari ACC, de Morais MB. Fecal microbiota analysis of children with small intestinal bacterial overgrowth among residents of an urban slum in Brazil. J Pediatr (Rio J). 2018 Sep-Oct;94(5):483-490. doi: 10.1016/j.jped.2017.09.003. Epub 2017 Oct 16. |
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| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| NIH |
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| Metronidazole | Drug | Administered alone: 20-30 mg/kg/day divided every 8 hours, with a maximum 750 mg/dose Co-administered with Trimethoprim-sulfamethoxazole: 35-50 mg/kg/day divided every 8 hours, with a maximum 750 mg/dose |
|
| Amoxicillin-Clavulanate (4:1 formulation) | Drug | 20-40 mg amoxicillin/kg/day divided every 8 hours, with maximum daily dose of 1,500 mg |
|
Area under the hydrogen curve will be calculated at baseline, day 15, and day 45. An average of these values will be taken to construct this variable. |
| Baseline, day 15, day 45 |
| Fecal Myeloperoxidase | Fecal myeloperoxidase levels as measured by a commercially available ELISA kit. | Baseline, day 15, day 45 |
| Fecal Neopterin | Fecal neopterin levels as measured by a commercially available ELISA kit. | Baseline, day 15, day 45 |
| Fecal Calprotectin | Fecal calprotectin levels as measured by a commercially available ELISA kit. | Baseline, day 15, day 45 |
| 26758185 | Background | Donowitz JR, Haque R, Kirkpatrick BD, Alam M, Lu M, Kabir M, Kakon SH, Islam BZ, Afreen S, Musa A, Khan SS, Colgate ER, Carmolli MP, Ma JZ, Petri WA Jr. Small Intestine Bacterial Overgrowth and Environmental Enteropathy in Bangladeshi Children. mBio. 2016 Jan 12;7(1):e02102-15. doi: 10.1128/mBio.02102-15. |
| 30126990 | Background | Vonaesch P, Morien E, Andrianonimiadana L, Sanke H, Mbecko JR, Huus KE, Naharimanananirina T, Gondje BP, Nigatoloum SN, Vondo SS, Kaleb Kandou JE, Randremanana R, Rakotondrainipiana M, Mazel F, Djorie SG, Gody JC, Finlay BB, Rubbo PA, Wegener Parfrey L, Collard JM, Sansonetti PJ; Afribiota Investigators. Stunted childhood growth is associated with decompartmentalization of the gastrointestinal tract and overgrowth of oropharyngeal taxa. Proc Natl Acad Sci U S A. 2018 Sep 4;115(36):E8489-E8498. doi: 10.1073/pnas.1806573115. Epub 2018 Aug 20. |
| 1833523 | Background | Pereira SP, Khin-Maung-U, Bolin TD, Duncombe VM, Nyunt-Nyunt-Wai, Myo-Khin, Linklater JM. A pattern of breath hydrogen excretion suggesting small bowel bacterial overgrowth in Burmese village children. J Pediatr Gastroenterol Nutr. 1991 Jul;13(1):32-8. doi: 10.1097/00005176-199107000-00006. |
| 23139610 | Background | Mello CS, Tahan S, Melli LC, Rodrigues MS, de Mello RM, Scaletsky IC, de Morais MB. Methane production and small intestinal bacterial overgrowth in children living in a slum. World J Gastroenterol. 2012 Nov 7;18(41):5932-9. doi: 10.3748/wjg.v18.i41.5932. |
| 17372830 | Background | dos Reis JC, de Morais MB, Oliva CA, Fagundes-Neto U. Breath hydrogen test in the diagnosis of environmental enteropathy in children living in an urban slum. Dig Dis Sci. 2007 May;52(5):1253-8. doi: 10.1007/s10620-006-9288-9. Epub 2007 Mar 20. |
| 19344474 | Background | Gasbarrini A, Corazza GR, Gasbarrini G, Montalto M, Di Stefano M, Basilisco G, Parodi A, Usai-Satta P, Vernia P, Anania C, Astegiano M, Barbara G, Benini L, Bonazzi P, Capurso G, Certo M, Colecchia A, Cuoco L, Di Sario A, Festi D, Lauritano C, Miceli E, Nardone G, Perri F, Portincasa P, Risicato R, Sorge M, Tursi A; 1st Rome H2-Breath Testing Consensus Conference Working Group. Methodology and indications of H2-breath testing in gastrointestinal diseases: the Rome Consensus Conference. Aliment Pharmacol Ther. 2009 Mar 30;29 Suppl 1:1-49. doi: 10.1111/j.1365-2036.2009.03951.x. |
| 31281862 | Background | Donowitz JR, Parikh HI, Taniuchi M, Gilchrist CA, Haque R, Kirkpatrick BD, Alam M, Kakon SH, Islam BZ, Afreen S, Kabir M, Nayak U, Colgate ER, Carmolli MP, Petri WA Jr. Increased Fecal Lactobacillus Is Associated With a Positive Glucose Hydrogen Breath Test in Bangladeshi Children. Open Forum Infect Dis. 2019 Jun 1;6(7):ofz266. doi: 10.1093/ofid/ofz266. eCollection 2019 Jul. |
| 32023228 | Background | Pimentel M, Saad RJ, Long MD, Rao SSC. ACG Clinical Guideline: Small Intestinal Bacterial Overgrowth. Am J Gastroenterol. 2020 Feb;115(2):165-178. doi: 10.14309/ajg.0000000000000501. |
| 34693912 | Background | Donowitz JR, Pu Z, Lin Y, Alam M, Ferdous T, Shama T, Taniuchi M, Islam MO, Kabir M, Nayak U, Faruque ASG, Haque R, Ma JZ, Petri WA Jr. Small Intestine Bacterial Overgrowth in Bangladeshi Infants Is Associated With Growth Stunting in a Longitudinal Cohort. Am J Gastroenterol. 2022 Jan 1;117(1):167-175. doi: 10.14309/ajg.0000000000001535. |
| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| D008795 | Metronidazole |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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