Trial Outcomes & Findings for Safety, Acceptability, and Feasibility of Enterade® (NCT NCT03782272)

NCT ID: NCT03782272

Last Updated: 2021-02-04

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 0-21 days
• Results posted on: 2021-02-04

Participant Flow

Participant milestones

Measure	AA-ORS Those receiving enterade oral re-hydration solution with amino acids 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.	Placebo Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	AA-ORS n=6 Participants Those receiving enterade oral re-hydration solution with amino acids 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.	Placebo n=6 Participants Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water.	Total n=12 Participants Total of all reporting groups
Age, Continuous	18 months n=6 Participants	16 months n=6 Participants	18 months n=12 Participants
Sex: Female, Male Female	1 Participants n=6 Participants	3 Participants n=6 Participants	4 Participants n=12 Participants
Sex: Female, Male Male	5 Participants n=6 Participants	3 Participants n=6 Participants	8 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Kenya	6 participants n=6 Participants	6 participants n=6 Participants	12 participants n=12 Participants
Length	78.95 cm n=6 Participants	75.3 cm n=6 Participants	78 cm n=12 Participants
Weight	10.55 kg n=6 Participants	9.03 kg n=6 Participants	10.0 kg n=12 Participants
Mid-upper arm circumference (MUAC)	150.5 mm n=6 Participants	141 mm n=6 Participants	145 mm n=12 Participants

PRIMARY outcome

Timeframe: 0-21 days

Population: This is the intention-to-treat population with all participants randomized and received at least one dose.

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.

Outcome measures

Measure	AA-ORS n=6 Participants Those receiving enterade oral re-hydration solution with amino acids 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.	Placebo n=6 Participants Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water.
Frequency of Adverse Events or Serious Adverse Events	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 0-14 days

Population: Intention-to-treat

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

Outcome measures

Measure	AA-ORS n=12 Participants Those receiving enterade oral re-hydration solution with amino acids 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.	Placebo Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water.
Volume of Daily Consumption of Study Product	212.5 ml Interval 181.0 to 234.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of acylcarnitines assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of intestinal fatty acid-binding protein [I-FABP] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of soluble CD14 [sCD14] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of glucagon-like peptide 2 [GLP-2] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of insulin-like growth factor 1 [IGF-1] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of fibroblast growth factor 21 [FGF21] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of alpha-1-acid glycoprotein [AGP] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of c-reactive protein [CRP] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of ferritin assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of soluble transferrin receptor [sTfR] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of retinol-binding protein 4 [RBP4] assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 15

Population: Due to study termination, exploratory analyses were not conducted on specimens collected.

Plasma concentration of thyroglobulin assessed at baseline and day 15 of follow-up.

Outcome measures

Outcome data not reported

Adverse Events

AA-ORS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AA-ORS n=6 participants at risk Those receiving enterade oral re-hydration solution with amino acids 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.	Placebo n=6 participants at risk Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • 21 days	0.00% 0/6 • 21 days

Additional Information

Gwen Ambler, Clinical Research Officer

PATH

Phone: +1-206-285-3500

Email: gambler@path.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place