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

Официальное название

A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth

Обзор

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.

Вмешательства

• Препарат Trimethoprim-sulfamethoxazole (TMP/SMX)
  8-10 mg/kg/day divided every 12 hours, with a maximum 160 mg/dose; dosing based on Trimethoprim
• Препарат Metronidazole
  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
• Препарат Amoxicillin-Clavulanate (4:1 formulation)
  20-40 mg amoxicillin/kg/day divided every 8 hours, with maximum daily dose of 1,500 mg

Первичные конечные точки

• Conversion to Glucose Hydrogen Breath Test (GHBT) Negativity at Day 15 [Срок оценки: Day 15]

Вторичные конечные точки (5)

• Conversion to GHBT Negativity at Day 45 [Срок оценки: Day 45]
• Average Glucose Hydrogen Breath Test Area Under the Curve [Срок оценки: Baseline, day 15, day 45]
• Fecal Myeloperoxidase [Срок оценки: Baseline, day 15, day 45]
• Fecal Neopterin [Срок оценки: Baseline, day 15, day 45]
• Fecal Calprotectin [Срок оценки: Baseline, day 15, day 45]

Критерии участия

Критерии включения

• Positive glucose hydrogen breath test (GHBT)
• Weight-for-age Z score > -1
• Length-for-age Z score > -1

Критерии исключения

• Presence of known chronic or congenital illness, including developmental delay
• Presence of acute gastrointestinal illness in the preceding 14 days
• Antibiotic use in the preceding 14 days
• Previous adverse reaction to any of the three study medications or other drugs in the same antibiotic classes
• Sibling previously enrolled in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) — Dhaka

Публикации

• 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. PMID 23974062
• 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. PMID 29049893
• 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. PMID 26758185
• 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 tra PMID 30126990
• 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. PMID 1833523
• 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. PMID 23139610
• 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. PMID 17372830
• 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 ind PMID 19344474

Идентификаторы

NCT: NCT07451171 · 302580 · 1R01HD113733-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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