Clinical trial NCT03451253: Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
Official title: Effects of an Amino Acid Mixture Versus a Sugar Based Sports Drink on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Short Bowel Syndrome
Ileostomy - Stoma
Lead sponsor: Entrinsic Bioscience Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: GI output
timeFrame: total 8 weeks
Secondary outcomes:
measure: Fluid Balance
timeFrame: 8 weeks
measure: Tolerability of Drink
timeFrame: 8 weeks
measure: Quality of Life Index
timeFrame: 8 weeks
measure: Quality of Life Index
timeFrame: 8 weeks
measure: Changes in Blood
timeFrame: 8 weeks
measure: Changes in heart rate
timeFrame: 8 weeks
measure: Changes in Lactulose-Mannitol Test
timeFrame: 8 weeks
measure: Immune Response based on Cytokine Levels
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brighan and Women's Hospital
state: Massachusetts
city: Nashua
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
References: