Ignite Creation Date:
2024-05-06 @ 12:33 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03782272
Status:
TERMINATED
Last Update Posted:
2021-02-04
First Post:
2018-05-16
Brief Title:
Safety Acceptability and Feasibility of Enterade
Sponsor:
PATH
Organization:
PATH
Study Overview
Official Title:
Safety Acceptability and Feasibility of Enterade in Children at Risk for Environmental Enteric Dysfunction in Kakamega County Kenya
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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 studys termination
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFE
Brief Summary:
This is a randomized double-blinded placebo-controlled pilot study to determine the safety acceptability and feasible pediatric dosagetolerability 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 ClinicalTrialsgov
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 ClinicalTrialsgov
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 stunting reduced cognitive development and reduced oral vaccine responsiveness An effective EED therapeutic would offer an opportunity to improve child growth and development in LRS One promising intervention enterade an amino acid-based oral rehydration solution AA-ORS is a medical food product already sold in the United States It consists of oral rehydration salts and a proprietary blend of amino acids designed to restore gut function improve nutrient and electrolyte absorption and improve barrier integrity There is evidence that this AA-ORS reduces inflammation and promotes healing of damaged intestinal epithelium in murine models of intestinal damage irradiated gut and it may provide benefit to pediatric EED patients Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure The results from this exploratory mixed-methods study could have broad implications for possible future studies among pediatric patients with intestinal injury resulting from EED and future product development and program strategies for EED interventions
The study was terminated prematurely after study product was found on site that did not meet product specifications Enrollment and all study product dosing was halted previously enrolled participants were followed through planned study visits and assessments An additional 6-week safety follow-up period was added to study procedures No study-related adverse events were reported during per-protocol activities or from the additional 6-week follow-up
The study was terminated prematurely after study product was found on site that did not meet product specifications Enrollment and all study product dosing was halted previously enrolled participants were followed through planned study visits and assessments An additional 6-week safety follow-up period was added to study procedures No study-related adverse events were reported during per-protocol activities or from the additional 6-week follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None