Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03451253
• Other study ID #: 2017P000097
• Status: Terminated
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: March 23, 2021

Study information

• Verified date: March 2023
• Source: Entrinsic Bioscience Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 23, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileostomy - Stoma
• Inflammation
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Short Bowel Syndrome

Intervention

Other:
• amino acid mixture beverage
commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.
• glucose-based sports drink
Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.

Locations

Country	Name	City	State
United States	Brighan and Women's Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Dartmouth-Hitchcock	Nashua	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Entrinsic Bioscience Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Fluid Balance	Fluid balance - intake vs output	8 weeks
Secondary	Tolerability of Drink	Taste perception Survey	8 weeks
Secondary	Quality of Life Index	Inflammatory Bowel Disease Questionnaire (IBDQ)	8 weeks
Secondary	Quality of Life Index	SF-36 Questionnaire	8 weeks
Secondary	Changes in Blood	mm Hg	8 weeks
Secondary	Changes in heart rate	Beats per minute	8 weeks
Secondary	Changes in Lactulose-Mannitol Test	The standard test for leaky gut syndrome	8 weeks
Secondary	Immune Response based on Cytokine Levels		8 weeks