Short Bowel Syndrome
Conditions
Keywords
Oral Rehydration Solutions
Brief summary
This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .
Detailed description
Patients with short bowel syndrome (SBS) have a critical reduction of the gut mass/function that is below the minimum needed to absorb nutrients and fluids required for adequate homeostasis. There are limited data regarding the optimal choice for oral rehydration in the setting of SBS that can maximize fluid absorption in the setting of diarrhea with limited intestinal absorptive surface area. The investigators propose a preliminary open label single center study assessing tolerability and palatability of enterade® ( an amino acid (AA) based oral rehydrating solution (ORS)) and compare to baseline. Eligible patients with SBS will participate in a 14-day trial monitoring and measuring tolerability and palatability of an AA-ORS, enterade®, in addition to their regular diet.
Interventions
DIETARY_SUPPLEMENTEnterade® oral rehydration solution
Commercially available amino acid based oral rehydration solution
Sponsors
Entrinsic Bioscience Inc.
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Open label single center pilot study
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease) between the ages of 1-17 * Patients who are in intestinal continuity or with diverting ileostomy, jejunostomy * Patients must be on a stable enteral nutrition regimen with oral rehydration fluids that are taken orally. * Stable GI medication regimen (e.g., loperamide, cholestyramine, small bowel bacterial overgrowth (SBBO) regimen)
Exclusion criteria
* Patients receiving IV antibiotics within the previous 72h. * Patients with a primary diagnosis of a motility disorder (e.g., chronic intestinal pseudo-obstruction) or epithelial cell disorder (e.g., microvillus inclusion disease) * Malnourished (as defined by Weight/Height Z-score (WHZ) \<-2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy | Total study duration14 days | 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. |
| Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity | Total study duration 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance: Reported Episodes of Abdominal Distension and Emesis | 14 days | Number of episodes reported of abdominal distension and emesis during study period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS | 14 days | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
No run-in or wash out period prior to participating in study.
Participants by arm
| Arm | Count |
|---|---|
| AA ORS Arm Patients will consume commercially amino acid based oral rehydration solution (enterade®).
Enterade® oral rehydration solution: Commercially available amino acid based oral rehydration solution | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | AA ORS Arm | — |
|---|---|---|
| Age, Continuous | 2.6 years | — |
| Presence of ileostomy or jejunostomy | 2 Participants | — |
| Primary Short Bowel Syndrome Diagnosis Hirschsprungs Disease | 2 Participants | — |
| Primary Short Bowel Syndrome Diagnosis In-utero Volvulus | 1 Participants | — |
| Primary Short Bowel Syndrome Diagnosis Necrotizing enterocolitis | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 4 Participants | — |
| Residual Small Bowel Length | 83.3 centimeters (cm) | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity
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.
Time frame: Total study duration 14 days
Population: Participants consumed amino acid-based ORS (enterade)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Outcome | Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity | .3 Stools per day |
Primary
Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy
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.
Time frame: Total study duration14 days
Population: Participants consumed amino acid-based ORS (enterade)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Outcome | Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy | 50 mL/day |
Secondary
Tolerance: Reported Episodes of Abdominal Distension and Emesis
Number of episodes reported of abdominal distension and emesis during study period
Time frame: 14 days
Population: Participants consuming amino acid oral rehydration solution (enterade)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Outcome | Tolerance: Reported Episodes of Abdominal Distension and Emesis | Reported episodes of Abdominal Distension | 0 Episodes |
| Primary Outcome | Tolerance: Reported Episodes of Abdominal Distension and Emesis | Reported episodes of Emesis | 0 Episodes |
Other Pre-specified
Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS
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).
Time frame: 14 days
Population: Participants consuming enterade (amino acid oral rehydration solution)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Outcome | Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS | 0 mm |