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Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults

This study has been completed.
Sponsor:
Collaborator:
University of Basel
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00672308
First received: May 3, 2008
Last updated: May 5, 2008
Last verified: December 2004
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults

Resource links provided by NLM:


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
Experimental: 1
Benefiber (25 g/L)
Other: Benefiber with ORS Other: the reduced-osmolarity WHO-ORS without added Benefiber
Experimental: 2
Benefiber (50 g/L)
Other: Benefiber Other: Benefiber with ORS
Experimental: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided by International Centre for Diarrhoeal Disease Research, Bangladesh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00672308     History of Changes
Other Study ID Numbers: 2002—034
Study First Received: May 3, 2008
Last Updated: May 5, 2008
Health Authority: Bangladesh: Ethical Review Committee

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

Additional relevant MeSH terms:
Cholera
Bacterial Infections
Gram-Negative Bacterial Infections
Vibrio Infections

ClinicalTrials.gov processed this record on November 20, 2014