Environmental Enteric DysfunctionNCT03263871
PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
A study testing PTM202 and micro-nutrient sprinkles in people with Environmental Enteric Dysfunction, run by University of Virginia at 1 site in Bangladesh.
Trial summary
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction. Read more about this study
- Who is it for?
- Ages 6 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Environmental Enteric Dysfunction
- What is being tested?
- PTM202 and micro-nutrient sprinkles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBangladesh
- Study dates
- 14 Oct 2017to 15 Feb 2019
- 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 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 6 - 9 months old
- -1> Weight-for-age Z score > -3
- Parental consent to participate and receive daily supplementation with either PTM202 and/or micro-nutrient sprinkles, participate in specimen collection
Who cannot join
- Presence of known kidney, liver, heart, developmental, or neurologic disease
- Allergy to milk and/or egg (assessed by history)
- Milk intolerance (assessed by history)
- Abnormal liver or kidney function tests
- Family is planning to move from the study area or children is enrolled to the other clinical trial within 3 months of follow up
- Child being exclusively breast fed at the time of enrollment
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
- Conditions
- Environmental Enteric Dysfunction
- Being tested
- PTM202, micro-nutrient sprinkles
- Keywords
- nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTM202Dietary supplement
PTM202 given twice daily for 30 days.
micro-nutrient sprinklesDietary supplement
Micro-nutrient sprinkles will be given twice daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | PTM202 and micro-nutrient sprinkles Receives: Dietary Supplement: PTM202; Dietary Supplement: micro-nutrient sprinkles |
| Control | Other | micro-nutrient sprinkles Receives: Dietary Supplement: micro-nutrient sprinkles |
What is being measured
The primary outcome is the main question the study is designed to answer.
EED biomarker composite score
composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein
Measured: 4 months
Secondary outcomes (4)
Weight gain
Measured: 4 months
Height gain
Measured: 4 months
Number of diarrheal episodes
Measured: 4 months
Glucose hydrogen breath test
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start14 Oct 2017
- Primary completion30 Dec 2018
- Study completion15 Feb 2019
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.
- 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
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Virginia Commonwealth University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263871
- Sponsor's protocol ID
- 19993
- Status last verified
- Apr 2019
- First submitted
- 24 Aug 2017
- Last updated
- 22 Apr 2019
- 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 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
- ClinicalTrials.gov ID
- NCT03263871
- Acronym / sponsor ID
- 19993
- Conditions
- Environmental Enteric Dysfunction
- Keywords
- nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Virginia Commonwealth University
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 28 Aug 2017 (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.
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: PTM202, Dietary Supplement: micro-nutrient sprinklesPTM202 and micro-nutrient sprinkles |
| Control | Other | Dietary Supplement: micro-nutrient sprinklesmicro-nutrient sprinkles |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 6 - 9 months old
- -1> Weight-for-age Z score > -3
- Parental consent to participate and receive daily supplementation with either PTM202 and/or micro-nutrient sprinkles, participate in specimen collection
Key exclusion criteria (6 listed)
- Presence of known kidney, liver, heart, developmental, or neurologic disease
- Allergy to milk and/or egg (assessed by history)
- Milk intolerance (assessed by history)
- Abnormal liver or kidney function tests
- Family is planning to move from the study area or children is enrolled to the other clinical trial within 3 months of follow up
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 |
|---|---|---|
| PTM202PTM202 given twice daily for 30 days. | Dietary supplement | Intervention |
| micro-nutrient sprinklesMicro-nutrient sprinkles will be given twice daily for 30 days. | Dietary supplement | Control, Intervention |
Primary outcome
EED biomarker composite score
Time frame: 4 months
composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein
4 secondary outcomes
Weight gain
Time frame: 4 months
Height gain
Time frame: 4 months
Number of diarrheal episodes
Time frame: 4 months
Glucose hydrogen breath test
Time frame: 4 months
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 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Environmental Enteric Dysfunction
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Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar
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Not yet recruitingPhase 2
Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
Environmental Enteric Dysfunction
Enrolling by invitation
Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan
Environmental Enteric Dysfunction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTM202 and micro-nutrient sprinkles in people with Environmental Enteric Dysfunction, run by University of Virginia 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 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 22 Apr 2019. 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?
EED biomarker composite score (time frame: 4 months). 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 22 Apr 2019.