A double-blind clinical trial to compare the efficacy and safety of a multiple amino acid-based ORS with the standard WHO-ORS in the management of non-cholera acute watery diarrhea in infants and young children: "VS002A" trial protocol

Trials. 2022 Aug 25;23(1):706. doi: 10.1186/s13063-022-06601-5.

Abstract

Background: Diarrhea is the second deadliest disease for under-five children globally and the situation is more serious in developing countries. Oral rehydration solution (ORS) is being used as a standard treatment for acute watery diarrhea for a long time. Our objective is to compare the efficacy of amino acid-based ORS "VS002A" compared to standard glucose-based WHO-ORS in infants and young children suffering from acute non-cholera watery diarrhea.

Methods: It is a randomized, double-blind, two-cell clinical trial at Dhaka Hospital of icddr,b. A total of 312 male children aged 6-36 months old with acute non-bloody watery diarrhea are included in this study. Intervention arm participants get amino acid-based ORS (VS002A) and the control arm gets standard glucose-based WHO-ORS. The primary efficacy endpoint is the duration of diarrhea in the hospital.

Discussion: Oral rehydration therapy (ORT) with the present ORS formulation has certain limitations - it does not reduce the volume, frequency, or duration of diarrhea. Additionally, the failure of present standard ORS to significantly reduce stool output likely contributes to the relatively limited use of ORS by mothers as they do not feel that ORS is helping their child recover from the episode of diarrhea. Certain neutral amino acids (e.g., glycine, L-alanine, L-glutamine) can enhance the absorption of sodium ions and water from the gut. By using this concept, a shelf-stable, sugar-free amino acid-based hydration medicinal food named 'VS002A' that effectively rehydrates, and improves the barrier function of the bowel following infections targeting the gastrointestinal tract has been developed. If the trial shows significant benefits of VS002A use, this may provide evidence to support consideration of the use of VS002A in the present WHO diarrhea management guidelines. Conversely, if there is no evidence of benefit, these results will reaffirm the current guidelines.

Trial registration: ClinicalTrials.gov NCT04677296 . Registered on December 21, 2020.

Keywords: Amino acid-based ORS; Diarrhea; Randomized; VS002A; WHO-ORS.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Bangladesh
  • Bicarbonates
  • Child, Preschool
  • Diarrhea* / therapy
  • Diarrhea, Infantile* / therapy
  • Double-Blind Method
  • Electrolytes
  • Fluid Therapy* / adverse effects
  • Fluid Therapy* / methods
  • Glucose
  • Glutamine
  • Humans
  • Infant
  • Male
  • Potassium Chloride
  • Randomized Controlled Trials as Topic
  • Rehydration Solutions* / adverse effects
  • Rehydration Solutions* / therapeutic use
  • Sodium Chloride
  • Treatment Outcome

Substances

  • Bicarbonates
  • Electrolytes
  • Glucose
  • Glutamine
  • Potassium Chloride
  • Rehydration Solutions
  • Sodium Chloride
  • World Health Organization oral rehydration solution

Associated data

  • ClinicalTrials.gov/NCT04677296

Grants and funding