Gastroenteritis AcuteNCT05247879
Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution
A study testing Glucose containing Oral Rehydration Solution (ORS) and Sugar free - amino acid and electrolyte ORS in people with Gastroenteritis Acute, run by Mead Johnson Nutrition at 4 sites in Thailand.
Trial summary
This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency departments with gastroenteritis. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Gastroenteritis Acute
- What is being tested?
- Glucose containing Oral Rehydration Solution (ORS) and Sugar free - amino acid and electrolyte ORS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesThailand
- Study dates
- 30 Jun 2022to 18 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 to 5 years of age, inclusive at randomization
- Hospitalized with mild to moderate dehydration due to ongoing diarrhea
- Signed informed consent obtained for child's participation in the study
Who cannot join
- Severe dehydration and/or use of IV fluids for current hospitalization
- Experiencing bloody diarrhea or diarrhea due to Cholera, Dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use
- In the opinion of the Investigator, not suitable for treatment with ORS
- Have any underlying disease or disorder that may, in the opinion of the Investigator, affect the results of the study if they were enrolled (includes, but is not limited to, gastrointestinal disorders such as Crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders)
- Cause of the dehydration is something other than diarrhea
- Known to be allergic to any of the components of the Investigational ORS
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
Ramathibodi Hospital
Bangkok
Siriraj Hospital
Bangkok
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Naresuan University Hospital
Phitsanulok
About this study
Official title: Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution in Children Ages 1-5 Years Presenting to Hospital With Mild or Moderate Dehydration Gastroenteritis: Randomized, Open-label, Controlled Trial
This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency departments with gastroenteritis.
- Conditions
- Gastroenteritis Acute
- Being tested
- Glucose containing Oral Rehydration Solution (ORS), Sugar free - amino acid and electrolyte ORS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose containing Oral Rehydration Solution (ORS)Dietary supplement
Oral rehydration solution
Sugar free - amino acid and electrolyte ORSDietary supplement
Glucose free oral rehydration solution
| Study group | Role | What they receive |
|---|---|---|
| Commercial reduced-osmolarity oral rehydration solution (ORS | Active comparator | Not described Receives: Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS) |
| VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes | Experimental | Not described Receives: Dietary Supplement: Sugar free - amino acid and electrolyte ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically assessed adequate rehydration based on clinical judgement of change in or absence of presenting symptoms from baseline (i.e. heart rate, urine output, etc.)
Assess change in clinical hydration status from presenting baseline status
Measured: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Secondary outcomes (14)
Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)
5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum
Measured: Baseline
Study ORS intake (units)
Measured: Every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Use of IV fluids
Measured: up to 24 hours or hospital discharge, whichever occurs first
Weight
kg
Measured: Every 4 hours up to 24 h or at hospital discharge, whichever occurs first
Participant comfort questionaire
Measured: baseline and 24 hours or hospital discharge, whichever occurs first
Parent satisfaction questionnaire
Measured: baseline and 24 hours or hospital discharge, whichever occurs first
Frequency of vomiting
Measured: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Frequency episodes of urination
Measured: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Frequency of liquid/watery stool
Measured: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Time to resolution of liquid/water stool
Measured: up to 24 hours or hospital discharge, whichever comes first
Stool for bacterial pathogen culture and viral antigens
Measured: up to 24 hours or hospital discharge, whichever comes first
Time ready for discharge
Measured: At discharge or 48 hours whichever occurs first
Medically confirmed adverse events collected throughout the study period
Measured: 0 hours through 7 days post discharge
Record patient use of antibiotics during hospitalization
Measured: up to 24 hours or hospital discharge, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start30 Jun 2022
- Primary completion20 Sep 2023
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteritis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247879
- Sponsor's protocol ID
- 5003
- Status last verified
- Mar 2024
- First submitted
- 7 Jan 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution in Children Ages 1-5 Years Presenting to Hospital With Mild or Moderate Dehydration Gastroenteritis: Randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT05247879
- Acronym / sponsor ID
- 5003
- Conditions
- Gastroenteritis Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency departments with gastroenteritis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial reduced-osmolarity oral rehydration solution (ORS | Active comparator | Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS) |
| VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes | Experimental | Dietary Supplement: Sugar free - amino acid and electrolyte ORS |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1 to 5 years of age, inclusive at randomization
- Hospitalized with mild to moderate dehydration due to ongoing diarrhea
- Signed informed consent obtained for child's participation in the study
Key exclusion criteria (6 listed)
- Severe dehydration and/or use of IV fluids for current hospitalization
- Experiencing bloody diarrhea or diarrhea due to Cholera, Dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use
- In the opinion of the Investigator, not suitable for treatment with ORS
- Have any underlying disease or disorder that may, in the opinion of the Investigator, affect the results of the study if they were enrolled (includes, but is not limited to, gastrointestinal disorders such as Crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders)
- Cause of the dehydration is something other than diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose containing Oral Rehydration Solution (ORS)Oral rehydration solution | Dietary supplement | Commercial reduced-osmolarity oral rehydration solution (ORS |
| Sugar free - amino acid and electrolyte ORSGlucose free oral rehydration solution | Dietary supplement | VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes |
Primary outcome
Clinically assessed adequate rehydration based on clinical judgement of change in or absence of presenting symptoms from baseline (i.e. heart rate, urine output, etc.)
Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Assess change in clinical hydration status from presenting baseline status
14 secondary outcomes
Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)
Time frame: Baseline
Study ORS intake (units)
Time frame: Every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Use of IV fluids
Time frame: up to 24 hours or hospital discharge, whichever occurs first
Weight
Time frame: Every 4 hours up to 24 h or at hospital discharge, whichever occurs first
Participant comfort questionaire
Time frame: baseline and 24 hours or hospital discharge, whichever occurs first
Parent satisfaction questionnaire
Time frame: baseline and 24 hours or hospital discharge, whichever occurs first
Frequency of vomiting
Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Frequency episodes of urination
Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Frequency of liquid/watery stool
Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Time to resolution of liquid/water stool
Time frame: up to 24 hours or hospital discharge, whichever comes first
Stool for bacterial pathogen culture and viral antigens
Time frame: up to 24 hours or hospital discharge, whichever comes first
Time ready for discharge
Time frame: At discharge or 48 hours whichever occurs first
Medically confirmed adverse events collected throughout the study period
Time frame: 0 hours through 7 days post discharge
Record patient use of antibiotics during hospitalization
Time frame: up to 24 hours or hospital discharge, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Gastroenteritis Acute
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Not yet recruitingObservational study
Cardiovascular Risk in Patients With IBD
Ulcerative Colitis (UC), Crohn's Diseases
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruiting
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
Children With Medical Complexity, Respiratory Tract Infections (RTI)
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose containing Oral Rehydration Solution (ORS) and Sugar free - amino acid and electrolyte ORS in people with Gastroenteritis Acute, run by Mead Johnson Nutrition at 4 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically assessed adequate rehydration based on clinical judgement of change in or absence of presenting symptoms from baseline (i.e. heart rate, urine output, etc.) (time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.