Comparing a new oral rehydration solution with standard treatment for acute watery diarrhea
Next Generation ORS: Randomized Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity With Acute Watery Diarrhea in Adults
This study is testing a new oral rehydration solution with calcium to see if it helps adults with acute watery diarrhea feel better compared to the standard treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 396 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT05814042 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new oral rehydration solution (ORS) that includes calcium, aimed at reducing the severity of acute watery diarrhea in adults. The study will enroll 396 participants who have experienced diarrhea for less than 24 hours, with a focus on both cholera and non-cholera cases. Participants will be randomly assigned to receive either the new ORS or the standard WHO ORS to assess safety and efficacy. The trial is designed to provide proof-of-concept for this innovative approach to treating diarrhea, which has significant implications for improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 who have a history of acute watery diarrhea for less than 24 hours.
Not a fit: Patients who are pregnant, have bloody diarrhea, or show signs of systemic infection requiring intravenous antibiotics will not benefit from this study.
Why it matters
Potential benefit: If successful, this new ORS could significantly improve the management of acute watery diarrhea, leading to faster recovery and reduced mortality rates.
How similar studies have performed: While there have been efforts to modify ORS, this specific approach targeting the calcium-sensing receptor is novel and has not been previously tested in humans.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dhaka
- ICDDR,B Dhaka Hospital — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Sam Cheng, MD. PhD — University of Florida
- Study coordinator: Shafiqul Sarker, MD
- Email: sasarker@icddrb.org
- Phone: 88-01713039813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.