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

NCT03451253 | Terminated DMC

• 1 other identifier: 2017P000097
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Inflammatory Bowel Diseases; Short Bowel Syndrome; Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Fluid Balance

  8 weeks

• Tolerability of Drink

  8 weeks

• Quality of Life Index

  8 weeks

• Quality of Life Index

  8 weeks

• Changes in Blood

  8 weeks

Study Arms (2)

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.

Other: amino acid mixture beverage

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.

Other: glucose-based sports drink

Interventions

amino acid mixture beverage OTHER

commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.

Also known as: enterade

amino acid mixture beverage

glucose-based sports drink OTHER

Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.

Also known as: Gatorade

glucose based sports drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Entrinsic Bioscience Inc.: lead

Study Sites (3)

Brighan and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dartmouth-Hitchcock

Nashua, New Hampshire, 03062, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Short Bowel Syndrome

Interventions

gatorade

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Malabsorption Syndromes; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single (physician) blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 1, 2018
• Study Start: April 12, 2018
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)