Next Generation ORS: Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea

University of Florida396 enrolled

Overview

Diarrhea remains a leading killer of children in need of better treatments.

Diarrhea remains a leading killer of children in need of better treatments. Oral Rehydration Solution (ORS) is currently the only oral therapy that is recommended for children with acute diarrhea. Although it is valuable for correcting dehydration and is considered the primary reason for the substantial reduction in mortality from diarrhea in children, ORS does not have the capacity to "halt" intestinal fluid loss and thus, does not offer a rapid relief of a child's diarrhea symptom, and its use by caregivers and medical practitioners has markedly dropped (estimate use in 1/3 of cases who need it). In recognition of its limitations, continuous efforts have been made to modify the composition of ORS. However, none has targeted the central diarrhea-causing pathways and produced a satisfactory outcome in children. New therapeutic approaches and methods are needed. The proposed new ORS is based on recent discovery of the first inclusive antidiarrheal mechanism in the intestine, CaSR (calcium-sensing receptor) that targets all known diarrhea causing pathways. It works in animals. This R21 is the 1st proof-of-concept clinical study in humans and is intended to investigate its safety and efficacy. Two Specific Aims are proposed to determine new ORS safety and efficacy in patients with diarrhea. In the safety study, the investigators propose to enroll 396 diarrheal adults (198 in Intervention New ORS group and 198 in standard WHO ORS). In the efficacy study, the investigators plan to enroll 396 diarrheal adults (198 in Intervention New ORS group and 198 in standard WHO ORS, these will be same patients employed for the safety study). These diarrheal patients will be recruited from the Dhaka area in Bangladesh. At the conclusion of the study, we expect to develop a novel oral rehydrating solution that is inexpensive and practical to use in all the countries. Hypothesis: the volume output Intervention should reduce stool weight/output of diarrhea by 30%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

396

Conditions

Diarrhea Cholera

Interventions

Next Generation ORS (oral rehydration solution) (including placeboDRUG

Nutrition used to stop diarrhea

Current standard control ORS (oral rehydration solution)DRUG

current standard control ORS in diarrheic patients with cholera

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult male and female patients, age between 18 and 60 years, history of acute watery diarrhea (defined as the passage of ≥3 loose or watery stools in the past 24 hours) for less than 24 h before admission, either signs of severe dehydration and stool positive for Vibrio cholerae, and successful rehydration with intravenous fluids within the first 6 h after admission (cholera group), or signs of some dehydration and stool negative for V. cholera (non-cholera group) , and successful rehydration with intravenous or oral fluids within the first 6 h Exclusion Criteria: * Pregnancy as determined by history of last menstrual period, bloody diarrhea, signs of systemic infection that needed intravenous antibiotics, or inability to rehydrate with intravenous fluid therapy in the first 6 h after admission.

Locations (1)

ICDDR,B Dhaka Hospital

Dhaka, Bangladesh

Outcomes

Primary Outcomes

Stool Output

Daily stool output was defined as the total weight of all stools (g) passed during a given 24-hour intervention day. Total stool output was defined as the cumulative weight of all stools (g) passed over the entire 72-hour study period or until diarrhea resolved, whichever occurred first.

Time frame: Day 1, day 2, Day 3, and entire 3 days

Secondary Outcomes

Duration of Diarrhea

Duration of diarrhea was the time (in hour) from randomization until cessation of diarrhea

Time frame: from randomization to end of treatment at day 3

Stool Frequency

Daily stool frequency was defined as the total number of diarrhea stools passed during a given 24-hour intervention day.

Time frame: Day 1, Day 2, Day 3

Vomiting

Daily volume of vomiting was defined as the total weight of all vomitus (g) during a given 24-hour intervention day.

Time frame: Day 1, Day 2, Day 3

Percentage of Patients Who Require Unscheduled Intravenous Therapy

Percentage of patients who require unscheduled intravenous therapy at Day1, Day 2 and Day 3 following intervention.

Time frame: Day 1, Day 2, Day 3

Intake of ORS

Intake of ORS (ml) from randomization until cessation of diarrhea in Day 1, Day2, and Day 3.

Time frame: Day 1, Day 2, Day 3

Data from ClinicalTrials.gov

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