Phase 3
N=396
Next Generation ORS: Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea
Diarrhea · Cholera
Bottom Line
View on ClinicalTrials.gov: NCT05814042 ↗Enrolled (actual)
396
Serious AEs
0.5%
Results posted
Apr 2026
Primary outcome: Primary: Stool Output — 4769; 4742; 1688; 1704 gram — p=0.9941
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Next Generation ORS (oral rehydration solution) (including placebo (Drug); Current standard control ORS (oral rehydration solution) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stool Output |
4769; 4742; 1688; 1704; 4242; 5008 | 0.9941 |
| SECONDARY Duration of Diarrhea |
24.75; 25.80; 14.6; 16.4 | 0.7056 |
| SECONDARY Stool Frequency |
21.4; 19.0; 8.8; 9.2; 16.5; 21.4 | 0.2733 |
| SECONDARY Vomiting |
313.5; 283; 111.4; 136; 27.7; 43.3 | 0.7298 |
| SECONDARY Percentage of Patients Who Require Unscheduled Intravenous Therapy |
4; 4; 6; 8; 1; 1 | 1.000 |
| SECONDARY Intake of ORS |
5107; 5105; 2992; 3145; 1075; 1458 | 0.7558 |
Summary
Diarrhea remains a leading killer of children in need of better treatments.
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.
Data sourced from ClinicalTrials.gov (NCT05814042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.