Trial Outcomes & Findings for Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome (NCT NCT03105362)

Results Overview

Ostomy output measured as milliliters per day. The mean of outputs where compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Total study duration14 days

Results posted on

2020-02-24

Participant Flow

Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease), who were on a stable enteral nutrition regimen (oral rehydration fluids taken orally) between the ages of 1-17 were recruited from clinic.

No run-in or wash out period prior to participating in study.

Participant milestones

Participant milestones
Measure	AA ORS Arm Patients consumed (orally) an amino acid (AA) based oral rehydration solution (ORS) (enterade®) for 2 weeks as part of their baseline enteral hydration needs.
Overall Study STARTED	4
Overall Study Completed 1 Week of Study	4
Overall Study Completed 2 Weeks of Study	3
Overall Study Completed 2 Week Questionaire	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AA ORS Arm Patients consumed (orally) an amino acid (AA) based oral rehydration solution (ORS) (enterade®) for 2 weeks as part of their baseline enteral hydration needs.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AA ORS Arm n=4 Participants Patients will consume commercially amino acid based oral rehydration solution (enterade®). Enterade® oral rehydration solution: Commercially available amino acid based oral rehydration solution
Age, Continuous	2.6 years n=4 Participants
Sex: Female, Male Female	0 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=4 Participants
Region of Enrollment United States	4 Participants n=4 Participants
Primary Short Bowel Syndrome Diagnosis Hirschsprungs Disease	2 Participants n=4 Participants
Primary Short Bowel Syndrome Diagnosis In-utero Volvulus	1 Participants n=4 Participants
Primary Short Bowel Syndrome Diagnosis Necrotizing enterocolitis	1 Participants n=4 Participants
Residual Small Bowel Length	83.3 centimeters (cm) n=3 Participants • One study participant had an unknown bowel length
Presence of ileostomy or jejunostomy	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Total study duration14 days

Population: Participants consumed amino acid-based ORS (enterade)

Ostomy output measured as milliliters per day. The mean of outputs where compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.

Outcome measures

Outcome measures
Measure	Primary Outcome n=1 Participants AA ORS arm-Stool Output in subjects w/ ostomy
Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy	50 mL/day Interval 50.0 to 50.0

PRIMARY outcome

Timeframe: Total study duration 14 days

Population: Participants consumed amino acid-based ORS (enterade)

Output was measured as frequency of stools per day. The mean output was compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.

Outcome measures

Outcome measures
Measure	Primary Outcome n=1 Participants AA ORS arm-Stool Output in subjects w/ ostomy
Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity	.3 Stools per day Interval 0.3 to 0.3

SECONDARY outcome

Timeframe: 14 days

Population: Participants consuming amino acid oral rehydration solution (enterade)

Number of episodes reported of abdominal distension and emesis during study period

Outcome measures

Outcome measures
Measure	Primary Outcome n=3 Participants AA ORS arm-Stool Output in subjects w/ ostomy
Tolerance: Reported Episodes of Abdominal Distension and Emesis Reported episodes of Abdominal Distension	0 Episodes
Tolerance: Reported Episodes of Abdominal Distension and Emesis Reported episodes of Emesis	0 Episodes

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days

Population: Participants consuming enterade (amino acid oral rehydration solution)

Rating of enterade® taste was compared to previous "patient baseline" oral rehydration solution taste. We compared measurements using the facial hedonic method 100-mm visual analog scale (worst (0mm) and best taste(100mm)). We utilized the difference between two measurements: Day 0 (baseline ORS) and Day 14 (last study day of Amino Acid-ORS consumption). The difference was reported (Day 14 minus value at Day 0).

Outcome measures

Outcome measures
Measure	Primary Outcome n=2 Participants AA ORS arm-Stool Output in subjects w/ ostomy
Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS	0 mm Interval 0.0 to 0.0

Adverse Events

AA ORS Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christopher Duggan

Boston Children's Hospital

Phone: 617-355-7612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place