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 range12 Months – 24 Months
SexALL
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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.
✓. Has a working mobile phone.
Exclusion criteria
✕. 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.
What they're measuring
1
Frequency of Adverse Events or Serious Adverse Events
✕. 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).