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

NCT ID: NCT05814042

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2024-12-31

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%.

Conditions

Diarrhea; Cholera

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nutrient based intervention

Nutrition supplement used to stop diarrhea

Group Type: EXPERIMENTAL

Next Generation ORS (oral rehydration solution) (including placebo

Intervention Type: DRUG

Nutrition used to stop diarrhea

Standard of Care oral rehydration solution

Standard of care nutrition supplement used to stop diarrhea.

Group Type: ACTIVE_COMPARATOR

Current standard control ORS (oral rehydration solution)

Intervention Type: DRUG

current standard control ORS in diarrheic patients with cholera

Interventions

Next Generation ORS (oral rehydration solution) (including placebo

Nutrition used to stop diarrhea

Intervention Type: DRUG

Current standard control ORS (oral rehydration solution)

current standard control ORS in diarrheic patients with cholera

Intervention Type: DRUG

Other Intervention Names

WHO Reduced Osmolarity ORS with Calcium; WHO Reduced Osmolarity ORS

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Cheng, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

ICDDR,B Dhaka Hospital

Dhaka, , Bangladesh

Countries

Bangladesh

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21AI169282-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202202746 -N -R

Identifier Type: -

Identifier Source: org_study_id