Environmental Enteric DysfunctionNCT05291559
Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
A study testing Enterade in people with Environmental Enteric Dysfunction, run by Virginia Commonwealth University at 1 site in Bangladesh.
Trial summary
This is a pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on efficacy will also be obtained. Read more about this study
- Who is it for?
- Ages 1 year to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Enteric Dysfunction
- What is being tested?
- Enterade
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBangladesh
- Study dates
- 18 Jul 2022to 7 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 1 year to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Length-for-age Z score (LAZ) between -1 and -3 standard deviations
- Lactulose mannitol ratio >0.09
Who cannot join
- Presence of known congenital or chronic diseases other than malnutrition
- Diarrhea (> 3 unformed stools in a 24-hour window) in the 7 days prior to screening
- Anticipated unavailability for study visits
- A sibling previously enrolled in this study
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
This is a pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on efficacy will also be obtained.
Read the detailed description
Primary Objectives
- To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age
- To assess the efficacy of Enterade (VS001) in treatment of environmental enteric dysfunction by comparing improvements in 2-h lactulose mannitol ratio between Enterade (VS001) and a placebo.
Secondary Objectives
- To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children aged 1 to 2 years.
- To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of intestinal inflammation between Enterade (VS001) and placebo.
- Conditions
- Environmental Enteric Dysfunction
- Being tested
- Enterade, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnteradeDietary supplement
Also called VS001
Enterade is a glucose-free, amino acid-based medical food containing specific amino acids (aspartic acid, valine, serine, threonine and tyrosine) in addition to electrolytes and a non-sugar sweetener.
PlaceboDietary supplement
The placebo is an identical product to Enterade except without added amino acids.
| Study group | Role | What they receive |
|---|---|---|
| Enterade (VS001) | Experimental | 237 mL (8 fluid oz) per os, once daily for 14 days Receives: Dietary Supplement: Enterade |
| Placebo | Placebo comparator | 237 mL (8 fluid oz) per os, once daily for 14 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in appetite
Parents will complete a study specific survey which will include questions about child's interest in food and food intake which will yield an appetite score.
Measured: Baseline to 14 days
Change in gastrointestinal health
Parents will complete a study specific survey which will include questions about child's gastrointestinal symptoms such as diarrhea, vomiting, nausea, bloating, or constipation to yield a gastrointestinal health score.
Measured: Baseline to 14 days
Change in 2 hour Lactulose mannitol ratio
Assessment of Lactulose mannitol ratio at baseline and day 14
Measured: Baseline to 14 days
Secondary outcomes (5)
Residual intervention volume
Summation of daily residual volume of unconsumed study product
Measured: 14 days
Fecal lactoferrin
Assessment of fecal lactoferrin concentration at baseline and day 14
Measured: 14 days
Fecal myeloperoxidase
Assessment of fecal myeloperoxidase concentration at baseline and day 14
Measured: 14 days
Fecal neopterin
Assessment of fecal neopterin concentration at baseline and day 14
Measured: 14 days
Fecal Reg 1 beta
Assessment of fecal Reg 1 beta concentration at baseline and day 14
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start18 Jul 2022
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental Enteric DysfunctionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Donowitz, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291559
- Sponsor's protocol ID
- HM20023567
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2022
- Last updated
- 10 Sep 2022
- 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 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
- ClinicalTrials.gov ID
- NCT05291559
- Acronym / sponsor ID
- HM20023567
- Conditions
- Environmental Enteric Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 22 Mar 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 pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on efficacy will also be obtained.
Detailed description
Primary Objectives
- To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age
- To assess the efficacy of Enterade (VS001) in treatment of environmental enteric dysfunction by comparing improvements in 2-h lactulose mannitol ratio between Enterade (VS001) and a placebo.
Secondary Objectives
- To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children aged 1 to 2 years.
- To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of intestinal inflammation between Enterade (VS001) and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enterade (VS001) | Experimental | Dietary Supplement: Enterade237 mL (8 fluid oz) per os, once daily for 14 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo237 mL (8 fluid oz) per os, once daily for 14 days |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Length-for-age Z score (LAZ) between -1 and -3 standard deviations
- Lactulose mannitol ratio >0.09
Key exclusion criteria (4 listed)
- Presence of known congenital or chronic diseases other than malnutrition
- Diarrhea (> 3 unformed stools in a 24-hour window) in the 7 days prior to screening
- Anticipated unavailability for study visits
- A sibling previously enrolled in this study
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 |
|---|---|---|
| EnteradeAlso: VS001Enterade is a glucose-free, amino acid-based medical food containing specific amino acids (aspartic acid, valine, serine, threonine and tyrosine) in addition to electrolytes and a non-sugar sweetener. | Dietary supplement | Enterade (VS001) |
| PlaceboThe placebo is an identical product to Enterade except without added amino acids. | Dietary supplement | Placebo |
Primary outcome
Change in appetite
Time frame: Baseline to 14 days
Parents will complete a study specific survey which will include questions about child's interest in food and food intake which will yield an appetite score.
Change in gastrointestinal health
Time frame: Baseline to 14 days
Parents will complete a study specific survey which will include questions about child's gastrointestinal symptoms such as diarrhea, vomiting, nausea, bloating, or constipation to yield a gastrointestinal health score.
Change in 2 hour Lactulose mannitol ratio
Time frame: Baseline to 14 days
Assessment of Lactulose mannitol ratio at baseline and day 14
5 secondary outcomes
Residual intervention volume
Time frame: 14 days
Fecal lactoferrin
Time frame: 14 days
Fecal myeloperoxidase
Time frame: 14 days
Fecal neopterin
Time frame: 14 days
Fecal Reg 1 beta
Time frame: 14 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 10 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Environmental Enteric Dysfunction
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Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
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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.
Jeffrey R Donowitz, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterade in people with Environmental Enteric Dysfunction, run by Virginia Commonwealth University 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 2 inclusion and 4 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 10 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
Change in appetite (time frame: Baseline to 14 days). The study lists 3 primary outcomes in all. 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 10 Sep 2022.