Safety, Acceptability, and Feasibility of Enterade®

NCT03782272 | Terminated Results DMC

• 1 other identifier: 1191395-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 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. 2.To determine the feasibility and best tolerated dose of AA-ORS among children with LAZ between -3 and -1.
3. 3.To determine the perceptions among caregivers on the acceptability of AA-ORS as a potential intervention for EED. (Qualitative)
4. 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.

Conditions

Stunting; Environmental Enteric Dysfunction

Outcome Measures

Primary Outcomes (2)

• Frequency of Adverse Events or Serious Adverse Events

  Frequency of adverse events or serious adverse events in study product and placebo arms through 21 days of follow-up as assessed by physical/clinical examination.

  0-21 days

• Volume of Daily Consumption of Study Product

  Total, average, and trends in daily study product volume consumed measured as milliliters per day through the 14 days of dosing.

  0-14 days

Other Outcomes (12)

• Exploratory - Metabolism: Plasma Concentration of Acylcarnitines

  Day 0 and Day 15

• Exploratory - Gut Damage: Plasma Concentration of Intestinal Fatty Acid-binding Protein [I-FABP]

  Day 0 and Day 15

• Exploratory - Microbial Translocation: Plasma Concentration of Soluble CD14 [sCD14]

  Day 0 and Day 15

Study Arms (2)

AA-ORS

EXPERIMENTAL

Those receiving enterade oral re-hydration solution with amino acids

Dietary Supplement: Enterade

Placebo

PLACEBO COMPARATOR

Those receiving placebo solution without amino acids or rehydration salts

Dietary Supplement: Placebo

Interventions

Enterade 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.

AA-ORS

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PATH: lead
• Maseno University: collaborator
• Kakamega County General Teaching & Referral Hospital: collaborator

Study Sites (1)

Kakamega County General Teaching and Referral Hospital

Kakamega, Kenya

Location

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gwen Ambler, Clinical Research Officer
• Organization: PATH

gambler@path.org

+1-206-285-3500

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a mixed-methods pilot study to assess the safety, acceptability, and feasible dosage of AA-ORS among children with mild to moderate stunting (LAZ between -1 and -3) who are at risk for EED and to assess the acceptability of this fluid supplementation for their caregivers. During the main study, up to 66 child participants will be randomized to receive 14 days of AA-ORS or placebo solution daily, dosing of up to 237 ml over a 3-hour period. Study staff and participants will be blinded to the study product allocation. Caregivers will store and return unused study product. Data collection methods to include direct observation of product consumption, structured surveys with caregivers, average daily volume consumed, and measurement of plasma/serum markers of metabolism, gut dysfunction, systemic inflammation, and micro-nutrient status pre- and post-administration of product.

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: December 20, 2018
• Study Start: February 26, 2019
• Primary Completion: March 20, 2019
• Study Completion: June 30, 2020
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)