Status:
TERMINATED
Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
Lead Sponsor:
Entrinsic Bioscience Inc.
Conditions:
Inflammatory Bowel Diseases
Short Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 t...
Eligibility Criteria
Inclusion
- 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:
- Need for IV fluids \>2x/month
- Intake of \> 1.5 liters of oral fluid daily
- 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
Exclusion
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03451253
Start Date
April 12 2018
End Date
March 23 2021
Last Update
March 23 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Brighan and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dartmouth-Hitchcock
Nashua, New Hampshire, United States, 03062
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599