Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children

Summary

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.

Timeline

Start

2026-04-18

Primary completion

2026-08-02

Completion

2026-09-01

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications