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High Amylose Maize Starch for Treatment of Cholera

NCT01823952 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2014-04-04

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • Nur H Alam, MD MBBS · International Centre for Diarrhoeal Disease Research, Bangladesh

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Bangladesh

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01823952 on ClinicalTrials.gov