Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults
ORS
1 other identifier
interventional
195
1 country
1
Brief Summary
In cholera, the function of small intestine is affected resulting in increased secretion of electrolytes and water and their reduced absorption leading to profuse watery diarrhoea. The human colon has the capacity to absorb water and electrolytes. A number of recent studies have shown that short chain fatty acids (SCFAs) such as acetate, butyrate and propionate stimulates absorption of sodium in the colon, which is not affected by cyclic AMP. It has also been shown that SCFAs inhibits c-AMP mediated chloride secretion in the colon. Benefiber (partially hydrolyzed guar gum) is water soluble fibre, and when added to ORS it undergoes fermentation in the colon liberating SCFAs. SCFAs not only serves as metabolic fuel to the enterocytes but they also enhance colonic absorption of salts and water. Thus, they have potentials to reduce the severity of diarrhoea in patients with cholera. The aim of this study is to assess the efficacy of Benefiber-added WHO-ORS in the management of adults with cholera. In this randomized, controlled clinical trial, a total of 174 adult males with cholera would be studied. Study patients would be selected from those who attend the Dhaka Hospital of ICDDR,B with a history of diarrhoea of less than 24 hours and signs of severe dehydration. They would be rehydrated using intravenous fluid (cholera saline) over 4 hrs during which a stool specimen would be subjected for dark-field microscopy for identification of V. cholerae. Those identified to have cholera would be randomized in equal numbers to receive either: a) Benefiber (25 g/L) added WHO-ORS, b) Benefiber (50 g/L) added to the new formulation (Na+ 75, glucose 75, Cl- 65, K+ 20 mmol/L, citrate 10 mmol/L, osmolarity 245 mosmol/L) of WHO-ORS , or c) the same WHO-ORS but without Benefiber for maintenance of hydration until resolution of diarrhoea. All patients would be treated with a single, 300 mg dose of doxycycline capsules and would be provided with the standard hospital diets. Fluid intake (intravenous fluid, ORS, and plain water) and output (stool, urine, and vomit) will be measured for each 6-hourly periods of the study. Patients would be hospitalized until resolution of their diarrhoea. Stool output, intake of intravenous fluid and ORS, the duration of diarrhoea, and the proportion of patients requiring "unscheduled intravenous fluid therapy" would be compared between the treatment groups. If Benefiber is found effective, it would be possible to formulate improved ORS for better case management of cholera.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2003
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 3, 2008
CompletedFirst Posted
Study publicly available on registry
May 6, 2008
CompletedMay 6, 2008
December 1, 2004
1.8 years
May 3, 2008
May 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total and 24-hourly watery stool output
24 months
Secondary Outcomes (1)
ORS intake and duration of diarrhoea, Clinical success (and failure), success (and failure) of oral rehydration therapy, and the proportion of patients requiring "unscheduled intravenous fluid therapy"
24 months
Study Arms (3)
1
EXPERIMENTALBenefiber (25 g/L)
2
EXPERIMENTALBenefiber (50 g/L)
3
EXPERIMENTALthe reduced-osmolarity WHO-ORS without Benefiber.
Interventions
Eligibility Criteria
You may qualify if:
- Age: 15 - 55 years
- Gender: Male (women would be excluded due to difficulties in separation of their urine from stools, particularly in those with severely dehydrated and associated mental obtundation).
- Duration of diarrhoea: 24 hours or less
- Clinical signs and symptoms of severe dehydration.
- Demonstration of V. cholerae in dark-field microscopy of a fresh stool specimen
- Written informed consent for participation in the study (for patients with temporary inability to provide consent due to their severe dehydration and mental obtundation, initial consent would be obtained from their attendants; however, the consent process would be re-applied to the patients when they are fully oriented)
You may not qualify if:
- Chronic or iatrogenic diarrhoea
- Dysentery (presence of visible blood in stool)
- History of receiving antimicrobial or antidiarrhoeal drugs prior to admission
- Presence of concomitant infection or underlying disease, which might complicate diagnosis and/or assessment of response to study interventions
- History of renal or hepatic dysfunction
- Failure to obtain informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICDDR,B
Dhaka, 1212, Bangladesh
Related Publications (1)
Alam NH, Ashraf H, Sarker SA, Olesen M, Troup J, Salam MA, Gyr N, Meier R. Efficacy of partially hydrolyzed guar gum-added oral rehydration solution in the treatment of severe cholera in adults. Digestion. 2008;78(1):24-9. doi: 10.1159/000152844. Epub 2008 Sep 4.
PMID: 18769066DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 3, 2008
First Posted
May 6, 2008
Study Start
May 1, 2003
Primary Completion
February 1, 2005
Study Completion
August 1, 2006
Last Updated
May 6, 2008
Record last verified: 2004-12