DiarrheaPhase 2/3ORSNCT05814042
Next Generation ORS: Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea
A Phase 2/3 study of Diarrhea and Cholera, run by University of Florida at 1 site in Bangladesh.
Trial summary
Diarrhea remains a leading killer of children in need of better treatments. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 1 siteBangladesh
- Study dates
- 21 Aug 2023to 31 Dec 2024
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Next Generation ORS: Randomized Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity With Acute Watery Diarrhea in Adults
Diarrhea remains a leading killer of children in need of better treatments.
Read the 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%.
- Being tested
- Next Generation ORS (oral rehydration solution) (including placebo, Current standard control ORS (oral rehydration solution)
- Medical subject headings
- Diarrhea, Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation ORS (oral rehydration solution) (including placeboDrug
Also called WHO Reduced Osmolarity ORS with Calcium
Nutrition used to stop diarrhea
Current standard control ORS (oral rehydration solution)Drug
Also called WHO Reduced Osmolarity ORS
current standard control ORS in diarrheic patients with cholera
| Study group | Role | What they receive |
|---|---|---|
| Nutrient based intervention | Experimental | Nutrition supplement used to stop diarrhea Receives: Drug: Next Generation ORS (oral rehydration solution) (including placebo |
| Standard of Care oral rehydration solution | Active comparator | Standard of care nutrition supplement used to stop diarrhea. Receives: Drug: Current standard control ORS (oral rehydration solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, day 2, Day 3, and entire 3 days
Secondary outcomes (5)
Duration of Diarrhea
Duration of diarrhea was the time (in hour) from randomization until cessation of diarrhea
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1, Day 2, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start21 Aug 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Control vs Intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Cheng, MD. PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814042
- Sponsor's protocol ID
- IRB202202746 -N -R
- Other IDs
- 1R21AI169282-01A1
- Acronym
- ORS
- Status last verified
- Jul 2025
- First submitted
- 3 Apr 2023
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No