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Suboptimal accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amino acid mixture beverage | Experimental | amino acid based hydration beverage. It will be given 8 oz, twice daily for the first 4 weeks of randomized blinded intervention. It will be given in same dose during 4 week open label intervention. |
|
| glucose based sports drink | Active Comparator | glucose based hydration beverage. It will be given 8oz, twice daily for the first 4 weeks of randomized blinded intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amino acid mixture beverage | Other | commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| GI output | 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 | total 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid Balance | Fluid balance - intake vs output | 8 weeks |
| Tolerability of Drink | Taste perception Survey | 8 weeks |
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Inclusion Criteria:
Colectomy with ileostomy
a. Ileostomy alone with less than 30 cm of small bowel resected i. A diverting ileostomy is permitted
Stable disease activity with no or mild inflammation felt not to significantly impact gastrointestinal (GI) output.
Any of the following:
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)
Stable doses of anti-diarrheal agents, octreotide or Gattex
Stable doses of anti-inflammatory agents and/or antibiotics
Willing to comply with study visits and assessments, including product intake.
Exclusion:
Chronic renal insufficiency glomerular filtration rate (GFR) < 40
Significant chronic liver disease altering fluid balance
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
Diabetes
Use of Lactulose/Mannitol solution is contraindicated
Current Diagnosis of Cancer
a. May be included if they are 4 or more months out from cancer therapy (i.e. chemotherapy, etc.)
Aversion to the taste of enterade® or inability to take the product as instructed
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brighan and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dartmouth-Hitchcock |
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4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.
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Single (physician) blinded.
|
| glucose-based sports drink | Other | Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring. |
|
|
| Quality of Life Index | Inflammatory Bowel Disease Questionnaire (IBDQ) | 8 weeks |
| Quality of Life Index | SF-36 Questionnaire | 8 weeks |
| Changes in Blood | mm Hg | 8 weeks |
| Changes in heart rate | Beats per minute | 8 weeks |
| Changes in Lactulose-Mannitol Test | The standard test for leaky gut syndrome | 8 weeks |
| Immune Response based on Cytokine Levels | 8 weeks |
| Nashua |
| New Hampshire |
| 03062 |
| United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D008286 | Malabsorption Syndromes |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C011259 | gatorade |
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