PTM202 for the Treatment of Environmental Enteric Dysfunction (EED) (NCT03263871) | Clinical Trial Compass
CompletedNot Applicable
PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
Bangladesh200 participantsStarted 2017-10-14
Plain-language summary
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
Who can participate
Age range
6 Months – 9 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.