- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01823952
High Amylose Maize Starch for Treatment of Cholera (RESTORS)
Phase 2, Single Centre, Randomized, Double-blind Study Conducted in Adult Males With Acute Dehydrating Diarrhea Due to Cholera With the Aim Being to Select One or More of the Three Fermentable Starches (FS) for an FS-HO-ORS Formulation.
A randomized, double-blind trial in adult males with acute dehydrating diarrhea of cholera comparing the safety, tolerability and efficacy of HAMS HO-ORS, HAMS 2.5% Acetate HO-ORS, HAMS 6% Acetate HO-ORS and HO-ORS.
The primary hypothesis is that at least one of the hypo-osmolar ORS containing high amylose maize starch 6% acetate (HAMSA6-HO-ORS), hypo-osmolar ORS containing high amylose maize starch 2.5% acetate (HAMSA2.5-HO-ORS) and a hypo-osmolar ORS containing high amylose maize starch (HAMS-HO-ORS), will significantly reduce diarrhea duration compared with hypo-osmolar (HO) ORS.
Specifically, the investigators expect that HAMSA6 will be the most effective preparation.
Visão geral do estudo
Status
Condições
Descrição detalhada
- Burden: Watery diarrhea including cholera continues to be a major cause of childhood mortality in developing countries, with an estimated 1.5 million children dying each year. This figure has greatly reduced from approximately 5 million diarrheal deaths annually 20 years ago, a phenomenon often attributed to the utilization of oral rehydration solution (ORS).
- Knowledge Gap: ORS is very effective in correcting dehydration and reducing mortality, but is not adequately used in many countries, partly due to the fact that it does not reduce diarrhea. The physiological basis for ORS is that glucose-stimulated sodium and fluid absorption is not inhibited by cyclic 3',5'-adenosine monophosphate (cAMP) and other diarrhea mediators which inhibit sodium chloride absorption. The conventional glucose-based ORS does not reduce duration or severity of diarrhea and may in fact paradoxically increase fecal fluid losses. Advances in ORS composition have included the universal adoption of hypo-osmolar ORS (HO-ORS) in 2003. Recent technological innovations have led to the use of amylase-resistant starches and their modifications in the treatment of diarrhea. Short chain fatty acids (SCFA), which are produced in colon from these non-absorbed carbohydrates, enhance sodium absorption. An orally administered, non-absorbed starch (i.e., one resistant to digestion by amylase) significantly reduced fecal fluid loss and the duration of diarrhea in patients with cholera.
- Relevance: Efforts are continuing to improve the efficacy of oral rehydration solution. As glucose stimulates sodium and water absorption in small intestine, short chain fatty acids (SCFAs) stimulate sodium and water absorption in the colon. In cholera, colonic function is also impaired due to the lack of SCFAs. The main source of SCFAs is the unabsorbed carbohydrates that are fermented in the colon by the colonic bacteria. The maize starch contains substantial amount of amylase resistant starch that escapes digestion and absorption in the small intestine and is fermented in the colon, liberating SCFAs. We expect that our experimental ORS containing maize starch will reduce the severity (stool volume) and enhance recovery (reduce duration) of diarrhoea.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Dhaka
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Mohakhali, Dhaka, Bangladesh, 1212
- Dhaka Hospital - icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
INCLUSION CRITERIA:
A participant is considered eligible for participation in the trial if the following inclusion criteria are satisfied on admission (Day 1, before randomization) to the hospital:
- Participant is a male between 18 and 65 years of age inclusive
- Severe watery diarrhea without fecal blood of less than 48 hours (with passage of 3 or more watery stools in the 24 hours before admission)
- Signs of severe dehydration as per ICDDR,B guidelines (modified WHO guideline)
- Dipstick test/Dark-field examination positive for Vibrio cholera
- Written informed consent is provided
- Participant is willing and able to comply with all trial requirements
EXCLUSION CRITERIA:
A participant who meets any of the following criteria on admission (before randomization) to the hospital will not qualify for the study
- Evidence or history of any clinically significant illness as per the Investigator's discretion.
- Known case of HIV or Hepatitis B
- History of cancer
- Known renal disease
- Frequent excessive alcohol use, binge drinking (e.g. men consume 5 or more drinks in about 2 hours) or use of illicit drugs within the past two years
- History of receiving antimicrobial or anti-diarrheal medication (loperamide, diphenoxylate, etc.) within seven days of admission
- Concomitant infection requiring antimicrobial therapy
- Donated blood or plasma or experienced clinically significant loss of blood within eight weeks prior to admission or who plan to donate blood within 1 month after study participation
- Clinically significant abnormal laboratory test results as determined by the investigator
- Treatment within 30 days prior to admission (or five half-lives of the compound, if longer) with any investigational agent or device
- History of seizure (including febrile seizure) or loss of consciousness;
- History of any GI Surgery related to Bowel resections and gastric anastomoses in past except Appendicitis
- For any reason, deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator or designee
- Prior enrolment in this trial
Plano de estudo
Como o estudo é projetado?
Coortes e Intervenções
Grupo / Coorte |
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Males
Adult 18-65
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Duration of Diarrhea
Prazo: 12 hrs w/o diarrhoea, up to max of 96 hrs
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Criteria evaluated: Duration of diarrhea during the study period (defined as time from randomisation to the last watery stool preceding two soft/formed stools or a 12 hour period without diarrhea, up to a maximum of 96 hours) |
12 hrs w/o diarrhoea, up to max of 96 hrs
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Stool output and fluid intake rate
Prazo: 0 to 96 hrs
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Criteria evaluated:
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0 to 96 hrs
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Safety & Tolerability as measured by adverse events, vital signs and lab parameters
Prazo: Approximately 24 hours after randomization
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Approximately 24 hours after randomization
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nur H Alam, MD MBBS, International Centre for Diarrhoeal Disease Research, Bangladesh
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RESTORS
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