Ileostomy - Stoma, Inflammatory Bowel Diseases, Short Bowel Syndrome
Conditions
Brief summary
This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches. Findings from this study and possible future studies could have broad implications for patients with malabsorption resulting from many underlying conditions, including IBD.
Detailed description
This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches. Findings from this study and possible future studies could have broad implications for patients with malabsorption resulting from many underlying conditions, including IBD.
Interventions
OTHERamino acid mixture beverage
commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.
Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.
Sponsors
Entrinsic Bioscience Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Single (physician) blinded.
Intervention model description
4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Colectomy with ileostomy a. Ileostomy alone with less than 30 cm of small bowel resected i. A diverting ileostomy is permitted 2. Stable disease activity with no or mild inflammation felt not to significantly impact gastrointestinal (GI) output. 3. Any of the following: 1. Need for IV fluids \>2x/month 2. Intake of \> 1.5 liters of oral fluid daily 4. GI output of \> 1.3 liters in a 24-hour period for three days each week during a 14 day screening period (does not need to be consecutive days) 5. Stable doses of anti-diarrheal agents, octreotide or Gattex 6. Stable doses of anti-inflammatory agents and/or antibiotics 7. Willing to comply with study visits and assessments, including product intake. Exclusion: 1. Chronic renal insufficiency glomerular filtration rate (GFR) \< 40 2. Significant chronic liver disease altering fluid balance 3. Uncontrolled flare of inflammatory disease a. (Inflammation can be present but at a stable at least partly controlled level) b. An anticipated change in medication in the next 3 months i. May be included 8 weeks after changing medications if they are stable c. Anticipated gastrointestinal surgery in the subsequent 3 months i. May be included if they are 4 months out from surgery and stable 4. Diabetes 5. Use of Lactulose/Mannitol solution is contraindicated 6. Current Diagnosis of Cancer a. May be included if they are 4 or more months out from cancer therapy (i.e. chemotherapy, etc.) 7. Aversion to the taste of enterade® or inability to take the product as instructed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI output | total 8 weeks | Change in GI output over a 24 hour period as the average of the 3 days every week for two different periods of 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Drink | 8 weeks | Taste perception Survey |
| Quality of Life Index | 8 weeks | Inflammatory Bowel Disease Questionnaire (IBDQ) |
| Changes in Blood | 8 weeks | mm Hg |
| Fluid Balance | 8 weeks | Fluid balance - intake vs output |
| Changes in Lactulose-Mannitol Test | 8 weeks | The standard test for leaky gut syndrome |
| Immune Response based on Cytokine Levels | 8 weeks | — |
| Changes in heart rate | 8 weeks | Beats per minute |
Countries
United States
Outcome results
None listed