TerminatedNCT01823952RESTORSUpdated Apr 4, 2014

High Amylose Maize Starch for Treatment of Cholera

An observational study in Diarrhea, sponsored by PATH. Terminated at 1 site in Bangladesh. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-04-04.

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.

Read the detailed description

Burden: Watery diarrhea including cholera continues to be a major cause of childhood mortality in developing countries, with an estimated 1.5 million children dying each year. This figure has greatly reduced from approximately 5 million diarrheal deaths annually 20 years ago, a phenomenon often attributed to the utilization of oral rehydration solution (ORS).
Knowledge Gap: ORS is very effective in correcting dehydration and reducing mortality, but is not adequately used in many countries, partly due to the fact that it does not reduce diarrhea. The physiological basis for ORS is that glucose-stimulated sodium and fluid absorption is not inhibited by cyclic 3',5'-adenosine monophosphate (cAMP) and other diarrhea mediators which inhibit sodium chloride absorption. The conventional glucose-based ORS does not reduce duration or severity of diarrhea and may in fact paradoxically increase fecal fluid losses. Advances in ORS composition have included the universal adoption of hypo-osmolar ORS (HO-ORS) in 2003. Recent technological innovations have led to the use of amylase-resistant starches and their modifications in the treatment of diarrhea. Short chain fatty acids (SCFA), which are produced in colon from these non-absorbed carbohydrates, enhance sodium absorption. An orally administered, non-absorbed starch (i.e., one resistant to digestion by amylase) significantly reduced fecal fluid loss and the duration of diarrhea in patients with cholera.
Relevance: Efforts are continuing to improve the efficacy of oral rehydration solution. As glucose stimulates sodium and water absorption in small intestine, short chain fatty acids (SCFAs) stimulate sodium and water absorption in the colon. In cholera, colonic function is also impaired due to the lack of SCFAs. The main source of SCFAs is the unabsorbed carbohydrates that are fermented in the colon by the colonic bacteria. The maize starch contains substantial amount of amylase resistant starch that escapes digestion and absorption in the small intestine and is fermented in the colon, liberating SCFAs. We expect that our experimental ORS containing maize starch will reduce the severity (stool volume) and enhance recovery (reduce duration) of diarrhoea.

Conditions studied

Diarrhea

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Keywords

HAMS
ORS
Cholera
Diarrhea

In context

Cholera

74 studies on the registry are indexed under Cholera; 11 are open to participants now.

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Lead sponsor

PATH is the lead sponsor of 111 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: Male
Accepts healthy volunteers: No
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.

Inclusion criteria

A participant is considered eligible for participation in the trial if the following inclusion criteria are satisfied on admission (Day 1, before randomization) to the hospital:

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

Exclusion criteria

EXCLUSION CRITERIA:

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

Study design

Enrollment: 106 participants (actual)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

Males
Adult 18-65

What researchers measure

Primary outcomes

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)
Time frame: 12 hrs w/o diarrhoea, up to max of 96 hrs

Secondary outcomes

Stool output and fluid intake rate
Criteria evaluated: * Total output of watery stool (g/kg body weight) * Weight of watery stool * Intake of oral fluids including ORS and plain water in mL/kg from time of randomization to the first soft/formed stool or 48 hours of treatment with study products, whichever is sooner * Proportion of patients who vomit in the first 24 hours * Proportion of patients who require unscheduled intravenous fluids post randomization * Amount (mL/kg) of unscheduled intravenous fluids required post randomization * Proportion of patients with diarrhea beyond 48 hours
Time frame: 0 to 96 hrs

Other outcomes

Safety & Tolerability as measured by adverse events, vital signs and lab parameters
* Proportion of patients with biochemical and symptomatic hyponatremia * Proportion of patients with adverse events deemed possibly or definitely related to treatment with the investigational products * Proportion of patients with abnormal biochemical and haematological values (any grade 3 as per CTCAE version IV criteria or above) * Proportion of patients with serious adverse events deemed possibly or definitely related to treatment with investigational products
Time frame: Approximately 24 hours after randomization

Study locations

1 site

Dhaka Hospital - icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh)
Mohakhali, Dhaka 1212, Bangladesh

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01823952
Lead sponsor: PATH
Responsible party: Sponsor
First posted: Apr 4, 2013
Start date: Apr 2013
Primary completion: Feb 2014
Completion: Feb 2014
Last update: Apr 4, 2014

Study contacts

Nur H Alam, MD MBBS

principal investigator · International Centre for Diarrhoeal Disease Research, Bangladesh

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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