Clinical trial NCT05814042: Next Generation ORS: Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea
Official title: Next Generation ORS: Randomized Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity With Acute Watery Diarrhea in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diarrhea
Cholera
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-04-14
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: Control vs Intervention
Primary purpose: TREATMENT

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

Detailed description: 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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Stool Volume Output
timeFrame: Year 2
Secondary outcomes:
measure: Duration of diarrhea
timeFrame: year 2
measure: Stool frequency
timeFrame: year 2
measure: Percentage of patients who vomit
timeFrame: year 2
measure: Percentage of patients who require unscheduled intravenous therapy
timeFrame: year 2
measure: Intake of ORS
timeFrame: year 2
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDR,B Dhaka Hospital
Study officials:
affiliation: University of Florida
name: Sam Cheng, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: