High Amylose Maize Starch for Treatment of Cholera

NCT01823952 | Terminated DMC

• 1 other identifier: RESTORS
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Diarrhea

Keywords

HAMS; ORS; Cholera; Diarrhea

Outcome Measures

Primary Outcomes (1)

• Duration of Diarrhea

  Criteria evaluated: Duration of diarrhea during the study period (defined as time from randomisation to the last watery stool preceding two soft/formed stools or a 12 hour period without diarrhea, up to a maximum of 96 hours)

  12 hrs w/o diarrhoea, up to max of 96 hrs

Secondary Outcomes (1)

• Stool output and fluid intake rate

  0 to 96 hrs

Other Outcomes (1)

• Safety & Tolerability as measured by adverse events, vital signs and lab parameters

  Approximately 24 hours after randomization

Study Arms (1)

Males

Adult 18-65

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study Population is 150 adult male patients: 40 each in the HAMS, HAMSA2.5 and HAMSA6 arms and 30 in the HO-ORS study arm.

You may qualify if:

• Participant is a male between 18 and 65 years of age inclusive
• Severe watery diarrhea without fecal blood of less than 48 hours (with passage of 3 or more watery stools in the 24 hours before admission)
• Signs of severe dehydration as per ICDDR,B guidelines (modified WHO guideline)
• Dipstick test/Dark-field examination positive for Vibrio cholera
• Written informed consent is provided
• Participant is willing and able to comply with all trial requirements

You may not qualify if:

• A participant who meets any of the following criteria on admission (before randomization) to the hospital will not qualify for the study
• Evidence or history of any clinically significant illness as per the Investigator's discretion.
• Known case of HIV or Hepatitis B
• History of cancer
• Known renal disease
• Frequent excessive alcohol use, binge drinking (e.g. men consume 5 or more drinks in about 2 hours) or use of illicit drugs within the past two years
• History of receiving antimicrobial or anti-diarrheal medication (loperamide, diphenoxylate, etc.) within seven days of admission
• Concomitant infection requiring antimicrobial therapy
• Donated blood or plasma or experienced clinically significant loss of blood within eight weeks prior to admission or who plan to donate blood within 1 month after study participation
• Clinically significant abnormal laboratory test results as determined by the investigator
• Treatment within 30 days prior to admission (or five half-lives of the compound, if longer) with any investigational agent or device
• History of seizure (including febrile seizure) or loss of consciousness;
• History of any GI Surgery related to Bowel resections and gastric anastomoses in past except Appendicitis
• For any reason, deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator or designee
• Prior enrolment in this trial

Sponsors & Collaborators

• PATH: lead

Study Sites (1)

Dhaka Hospital - icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh)

Mohakhali, Dhaka Division, 1212, Bangladesh

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Analysis of the sample for starch, short chain fatty acids and faecal microbiota.

MeSH Terms

Conditions

Diarrhea; Cholera

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Nur H Alam, MD MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 4, 2014

Record last verified: 2014-02

Locations

BA (1)