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Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults
This study has been completed.
Sponsors and Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
University of Basel, Switzerland
Information provided by: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00672308
  Purpose

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.


Condition Intervention Phase
Cholera
Other: Benefiber
Other: Benefiber with ORS
Other: the reduced-osmolarity WHO-ORS without added Benefiber
Phase II

MedlinePlus related topics: Diarrhea Drinking Water
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults

Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • total and 24-hourly watery stool output [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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" [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 195
Study Start Date: May 2003
Study Completion Date: August 2006
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Benefiber (25 g/L)
Other: Benefiber with ORS Other: the reduced-osmolarity WHO-ORS without added Benefiber
2: Experimental
Benefiber (50 g/L)
Other: Benefiber Other: Benefiber with ORS
3: Experimental
the reduced-osmolarity WHO-ORS without Benefiber.
Other: Benefiber with ORS
Benefiber (50 g/L)-supplemented, reduced-osmolarity WHO-ORS
Other: the reduced-osmolarity WHO-ORS without added Benefiber

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672308

Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Basel, Switzerland
  More Information

Publications indexed to this study:
Study ID Numbers: 2002—034
Study First Received: May 3, 2008
Last Updated: May 5, 2008
ClinicalTrials.gov Identifier: NCT00672308  
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Cholera, benefiber, ORS

Study placed in the following topic categories:
Bacterial Infections
Vibrio Infections
Cholera
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on January 16, 2009