Safety, Acceptability, and Feasibility of Enterade® (NCT03782272) | Clinical Trial Compass
TerminatedNot Applicable
Safety, Acceptability, and Feasibility of Enterade®
Stopped: Study product bottles were found on site that did not meet product specifications. This prompted a 6-week safety review of participants (no study-related findings) and resulted in the study's termination.
Kenya12 participantsStarted 2019-02-26
Plain-language summary
This is a randomized, double-blinded, placebo-controlled pilot study to determine the safety, acceptability, and feasible pediatric dosage/tolerability of enterade® solution, an amino acid-based oral rehydration solution (AA-ORS), for potential use in the management of environmental enteric dysfunction (EED) among children aged 12-24 months in Kakamega County, Kenya.
Primary objectives:
1. To determine the safety of a 2-week course of AA-ORS among children with length-for-age Z-scores (LAZ) between -1 and -3.
2. To determine the feasibility and best tolerated dose of AA-ORS among children with LAZ between -3 and -1.
Secondary objectives:
3. To determine the perceptions among caregivers on the acceptability of AA-ORS as a potential intervention for EED. (Qualitative)
Exploratory objectives:
4. To determine the impact of AA-ORS on markers of metabolism, gut dysfunction, systemic inflammation, and micronutrient status among children with LAZ between -3 and - 1.
Qualitative results will not be reported on ClinicalTrials.gov.
Who can participate
Age range
12 Months – 24 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
. Is between 12 and 24 months of age.
. LAZ between -3 and -1 standard deviations (SD).
. At least one week post routine immunization, healthy child visit, or vitamin A supplementation visit at the study site.
. Has a parent or legally acceptable representative willing and able to provide informed consent.
. No plans for travel outside of the community for the duration of the study.
. Is a parent or legally accepted representative of a child eligible for this study.
. Is 18 years of age or older.
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.
What they're measuring
1
Frequency of Adverse Events or Serious Adverse Events
. Has any sign of acute illness, including but not limited to fever, cough, and diarrhea.
. Is wasted (weight for length z-score \< -2 or mid-upper arm circumference \[MUAC\] \< 12.4 cm) or has pitting edema.
. Is exclusively breastfed.
. Is seeking medical attention at the health facility other than for routine, preventative care (e.g., immunization visit, vitamin supplementation).
. Has suffered within the prior week from illnesses that might impact nutritional status (e.g., severe diarrhea or pneumonia; vomiting; persistent diarrhea; cleft lip or palate; blindness; tuberculosis; jaundice; renal or cardiac disease; cerebral palsy; known metabolic disorders; and chromosomal disorders, including trisomy 21).
. Medical history of chronic health condition (i.e., HIV, hepatitis B or C, end stage renal disease, severe liver disease-absence of a diagnosis is sufficient).
. Participating in any other clinical trials.
. Recent (prior 2 weeks) use of antibiotics or any other medical treatments (including oral re-hydration solution), but not including vaccines or vitamin/mineral supplementation).