Esterified starch and oral rehydration solution as a treatment for acute infectious diarrhoea

A randomized controlled clinical trial in adults and children with acute infectious diarrhoea comparing the effects of high amylose maize starch acetate with high amylose maize starch as adjunct to oral rehydration solution on diarrhoea duration and stool output

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000912987

Enrollment

100

Registered

2011-08-25

Start date

2010-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The hypothesis behind the study is that high amylose maize starch acetate, a functional food that delivers acetate and other short chain fatty acids to the colon, will significantly shorten duration of diarrhoea and reduce diarrhoea stool output in patients with acute gastroenteritis. Short chain fatty acids are normally found in the lumen of the colon in high concentrations, being formed there by fermentation of carbohydrate. Reduction of colonic short chain fatty acids in diarrhoea is likely to prolong diarrhoea and slow recovery. High amylose maize starch, naturally found in several corn serovars, reduces diarrhoea in adults and children with gastroenteritis. We hypothesize that high amylose maize starch acetate, that delivers acetate to the colon besides undergoing fermentation to short chain fatty acids, will shorten diarrhoea to a greater extent than high amylose maize starch. In this double-blind randomized controlled clinical trial, adults with diarrhoea and dehydration will receive standard treatment including oral rehydration solution and early feeding, and in addition will receive either high amylose maize starch acetate or high amylose maize starch. Severely dehydrated patients will first receive intravenous fluids for rehydration followed by randomization. Duration of diarrhoea, diarrhoeal stool weight, need for unscheduled intravenous fluids will all be recorded.

Interventions

High amylose maize starch acetate, 10 g mixed per 200 ml oral rehydration solution (ORS), and consumed every hour and after every loose stool until stool consistency becomes formed or for a total of 72 hours.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

12 Years to 75 Years

Healthy volunteers

Inclusion criteria

Acute watery diarrhoea of less than three days’ duration and presence of dehydration.

Exclusion criteria

Bloody diarrhoea Concomitant illness including malignancy, sepsis, and a history of coronary artery disease or stroke.

Outcome results