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

NCT05814042 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB202202746 -N -R1R21AI169282-01A1
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diarrhea; Cholera

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1, day 2, Day 3, and entire 3 days

Secondary Outcomes (5)

• Duration of Diarrhea

  from randomization to end of treatment at day 3

• Stool Frequency

  Day 1, Day 2, Day 3

• Vomiting

  Day 1, Day 2, Day 3

• Percentage of Patients Who Require Unscheduled Intravenous Therapy

  Day 1, Day 2, Day 3

• Intake of ORS

  Day 1, Day 2, Day 3

Study Arms (2)

Nutrient based intervention

EXPERIMENTAL

Nutrition supplement used to stop diarrhea

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.

Drug: Current standard control ORS (oral rehydration solution)

Interventions

Next Generation ORS (oral rehydration solution) (including placebo DRUG

Nutrition used to stop diarrhea

Also known as: WHO Reduced Osmolarity ORS with Calcium

Nutrient based intervention

Current standard control ORS (oral rehydration solution) DRUG

current standard control ORS in diarrheic patients with cholera

Also known as: WHO Reduced Osmolarity ORS

Standard of Care oral rehydration solution

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

ICDDR,B Dhaka Hospital

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Diarrhea; Cholera

Interventions

World Health Organization oral rehydration solution; Calcium

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Limitations and Caveats

A limitation of this study is the inability to isolate the specific effect of calcium from non-specific ORS effects. A follow-up study using a fixed dose of calcium tablets vs. placebo tablets while keeping all participants on the same standard ORS would allow more precise receptor-level exposure and minimize osmotic confounding present with Ca-ORS. Also challenging was the variability in dosage, as lower intake in mild cases or in severe cases that subsequently improve might skew the outcomes.

Results Point of Contact

• Title: Sam Cheng
• Organization: University of Florida

sam.cheng@ufl.edu

203 687 9807

Study Officials

• Sam Cheng, MD. PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups: Control vs Intervention

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: August 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)