Status:
COMPLETED
Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
University of Basel
Conditions:
Cholera
Eligibility:
MALE
18-55 years
Phase:
PHASE2
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...
Detailed Description
Considerable interest has recently been generated on dietary fibers (DF), and soluble fibers have emerged both as a subject for research and therapeutic applications. The 'fiber hypothesis', put forwa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00672308
Start Date
May 1 2003
End Date
August 1 2006
Last Update
May 6 2008
Active Locations (1)
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1
ICDDR,B
Dhaka, Bangladesh, 1212