Status:
TERMINATED
Safety, Acceptability, and Feasibility of Enterade®
Lead Sponsor:
PATH
Collaborating Sponsors:
Maseno University
Kakamega County General Teaching & Referral Hospital
Conditions:
Stunting
Environmental Enteric Dysfunction
Eligibility:
All Genders
12-24 years
Phase:
NA
Brief 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 ...
Detailed Description
Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in low-resource settings (LRS), which in children has been associated with increased risk of growth stuntin...
Eligibility Criteria
Inclusion
- Pediatric and caregiver pairs (must meet inclusion criteria for both categories):
- Child:
- 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.
- Caregiver of child:
- 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.
- Is willing and able to provide informed consent.
- If illiterate-there is at least one literate adult living in the child's household.
Exclusion
- Pediatric and caregiver pairs (must meet none of the exclusion criteria for either category):
- Child:
- 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).
- Cannot give the necessary biological (blood) sample.
- Caregiver:
- Reports diarrhea in the household in the prior 7 days.
Key Trial Info
Start Date :
February 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03782272
Start Date
February 26 2019
End Date
June 30 2020
Last Update
February 4 2021
Active Locations (1)
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1
Kakamega County General Teaching and Referral Hospital
Kakamega, Kenya