Diarrhea, InfantileNCT04677296
Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children
A study testing VS002A and WHO-ORS in people with Diarrhea, Infantile, run by Entrinsic Bioscience Inc. at 1 site in Bangladesh.
Trial summary
Randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population Read more about this study
- Who is it for?
- Ages 6 to 36 months, men only
- Conditions the study is for
- Diarrhea, Infantile
- What is being tested?
- VS002A and WHO-ORS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteBangladesh
- Study dates
- 16 Jun 2021to 5 Sep 2022
- 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 6 to 36 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Age: 6 months - 36 months,
- Duration of diarrhea ≤48 hours,
- Some dehydration (judged clinically according to the "Dhaka method"),
- Written informed consent by either parent/guardian.
Who cannot join
- Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ <-3 or presence of nutritional edema)
- Patients with diarrhea due to cholera.
- Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.)
- Bloody diarrhea
- Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.)
- Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated
- Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Compare the Efficacy and Safety of a Multiple Amino-acid Based ORS "VS002A" With the Standard WHO-ORS in the Management of Non-cholera Acute Watery Diarrhea in Infants and Young Children
Randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population
- Conditions
- Diarrhea, Infantile
- Being tested
- VS002A, WHO-ORS
- Medical subject headings
- Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS002AOther
Amino acid based ORS/Medical food
WHO-ORSOther
WHO Oral rehydration solution, which is glucose based
| Study group | Role | What they receive |
|---|---|---|
| VS002A | Experimental | Amino acid based ORS/medical food (VS002A). Initial treatment dosing with VS002A will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss. Receives: Other: VS002A |
| Standard WHO-ORS | Active comparator | Standard WHO-ORS. Initial treatment dosing with WHO-ORS will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss. Receives: Other: WHO-ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea in hospital (hours)
number of hours of diarrhea after randomization
Measured: 5 days
Secondary outcomes (11)
Stool output
Stool output in the 1st 24 hours of hospitalization (g/kg body wt.), divided into two 12-hour periods
Measured: 1 day
Total stool output
Total amount of stool output during the study
Measured: 5 days
ORS intake in the 1st 24 hours of hospitalization
Amount of intervention drink consumed in the first 24 hours after randomization
Measured: 1 day
Total ORS intake
Amount of intervention drink consumed throughout the duration of the study
Measured: 5 days
Unscheduled IV (frequency/ORS group)
Frequency of IV fluids between he 2 groups
Measured: 5 days
Treatment failure (frequency/ORS group)
Frequency of treatment failures between the two groups
Measured: 5 days
Output and frequency of vomiting
Amount and frequency of vomiting between the two groups
Measured: 5 days
Change in body weight (between pre-randomization and post-treatment)
Body weight at randomization and post treatment
Measured: 5 days
Urine output in the 1st 24 hours of hospitalization (g/kg body wt.)
Amount of urine in the first 24 hours after randomization
Measured: 1 day
Total urine output during hospitalization
Total urine output (g/kg body wt.)
Measured: 5 days
Documented infectious agent
Stool culture and recording of infectious agent causing the diarrhea
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start16 Jun 2021
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea, InfantileStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blinded
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entrinsic Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Tahmeed Ahmed, MD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677296
- Sponsor's protocol ID
- PR-17028
- Status last verified
- Mar 2023
- First submitted
- 17 Nov 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Das R, Sobi RA, Sultana AA, Nahar B, Bardhan PK, Luke L, Fontaine O, Ahmed T. 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.
PubMed 36008819
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare the Efficacy and Safety of a Multiple Amino-acid Based ORS "VS002A" With the Standard WHO-ORS in the Management of Non-cholera Acute Watery Diarrhea in Infants and Young Children
- ClinicalTrials.gov ID
- NCT04677296
- Acronym / sponsor ID
- PR-17028
- Conditions
- Diarrhea, Infantile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Entrinsic Bioscience Inc.Industry (pharma, biotech, devices)
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 21 Dec 2020 (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.
Randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double blinded
| Arm | Type | Receives |
|---|---|---|
| VS002A | Experimental | Other: VS002AAmino acid based ORS/medical food (VS002A). Initial treatment dosing with VS002A will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss. |
| Standard WHO-ORS | Active comparator | Other: WHO-ORSStandard WHO-ORS. Initial treatment dosing with WHO-ORS will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 6 months - 36 months,
- Duration of diarrhea ≤48 hours,
- Some dehydration (judged clinically according to the "Dhaka method"),
- Written informed consent by either parent/guardian.
Key exclusion criteria (7 listed)
- Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ <-3 or presence of nutritional edema)
- Patients with diarrhea due to cholera.
- Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.)
- Bloody diarrhea
- Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.)
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 |
|---|---|---|
| VS002AAmino acid based ORS/Medical food | Other | VS002A |
| WHO-ORSWHO Oral rehydration solution, which is glucose based | Other | Standard WHO-ORS |
Primary outcome
Duration of diarrhea in hospital (hours)
Time frame: 5 days
number of hours of diarrhea after randomization
11 secondary outcomes
Stool output
Time frame: 1 day
Total stool output
Time frame: 5 days
ORS intake in the 1st 24 hours of hospitalization
Time frame: 1 day
Total ORS intake
Time frame: 5 days
Unscheduled IV (frequency/ORS group)
Time frame: 5 days
Treatment failure (frequency/ORS group)
Time frame: 5 days
Output and frequency of vomiting
Time frame: 5 days
Change in body weight (between pre-randomization and post-treatment)
Time frame: 5 days
Urine output in the 1st 24 hours of hospitalization (g/kg body wt.)
Time frame: 1 day
Total urine output during hospitalization
Time frame: 5 days
Documented infectious agent
Time frame: 5 days
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 22 Mar 2023.
- Derived from this study: PubMed 36008819Das R, Sobi RA, Sultana AA, Nahar B, Bardhan PK, Luke L, Fontaine O, Ahmed T. 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.
- Individual participant dataSharing planned: No
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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.
Tahmeed Ahmed, MD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VS002A and WHO-ORS in people with Diarrhea, Infantile, run by Entrinsic Bioscience Inc. at 1 site in Bangladesh.
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 4 inclusion and 7 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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?
Duration of diarrhea in hospital (hours) (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677296, which also lists 1 linked publication.
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 22 Mar 2023.