Safety, Acceptability, and Feasibility of Enterade®

NCT ID: NCT03782272

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-26
• Study Completion Date: 2020-06-30

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 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.

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.

Conditions

Stunting; Environmental Enteric Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

AA-ORS

Those receiving enterade oral re-hydration solution with amino acids

Group Type: EXPERIMENTAL

Enterade

Intervention Type: DIETARY_SUPPLEMENT

enterade® (an amino acid-based oral rehydration solution \[AA-ORS\]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes.

Placebo

Those receiving placebo solution without amino acids or rehydration salts

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

a placebo solution containing natural flavor, steviol (sweetener), and purified water.

Interventions

Enterade

enterade® (an amino acid-based oral rehydration solution \[AA-ORS\]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

a placebo solution containing natural flavor, steviol (sweetener), and purified water.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Child:

1. Is between 12 and 24 months of age.

2. LAZ between -3 and -1 standard deviations (SD).

3. At least one week post routine immunization, healthy child visit, or vitamin A supplementation visit at the study site.

4. Has a parent or legally acceptable representative willing and able to provide informed consent.

5. No plans for travel outside of the community for the duration of the study.

Caregiver of child:

1. Is a parent or legally accepted representative of a child eligible for this study.

2. Is 18 years of age or older.

3. Has a working mobile phone.

4. Is willing and able to provide informed consent.

5. If illiterate-there is at least one literate adult living in the child's household.

Exclusion Criteria

Child:

1. Has any sign of acute illness, including but not limited to fever, cough, and diarrhea.

2. Is wasted (weight for length z-score < -2 or mid-upper arm circumference [MUAC] < 12.4 cm) or has pitting edema.

3. Is exclusively breastfed.

4. Is seeking medical attention at the health facility other than for routine, preventative care (e.g., immunization visit, vitamin supplementation).

5. 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).

6. 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).

7. Participating in any other clinical trials.

8. 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).

9. Cannot give the necessary biological (blood) sample.

Caregiver:

Reports diarrhea in the household in the prior 7 days.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maseno University

OTHER

Sponsor Role: collaborator

Kakamega County General Teaching & Referral Hospital

OTHER

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kakamega County General Teaching and Referral Hospital

Kakamega, , Kenya

Countries

Kenya

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1191395-1

Identifier Type: -

Identifier Source: org_study_id