Inflammatory Bowel DiseasesNCT03451253
Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
A study testing amino acid mixture beverage and glucose-based sports drink in people with Inflammatory Bowel Diseases and Short Bowel Syndrome, run by Entrinsic Bioscience Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Short Bowel Syndrome, Ileostomy - Stoma
- What is being tested?
- amino acid mixture beverage and glucose-based sports drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Apr 2018to 23 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colectomy with ileostomy
- 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
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- 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.
Who cannot join
- Chronic renal insufficiency glomerular filtration rate (GFR) < 40
- Significant chronic liver disease altering fluid balance
- Uncontrolled flare of inflammatory disease
- (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
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- Current Diagnosis of Cancer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brighan and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
Dartmouth-Hitchcock
Nashua, New Hampshire, 03062
About this study
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
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.
Read the 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.
- Being tested
- amino acid mixture beverage, glucose-based sports drink
- Medical subject headings
- Inflammatory Bowel Diseases, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acid mixture beverageOther
Also called enterade
commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.
glucose-based sports drinkOther
Also called Gatorade
Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: glucose-based sports drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: total 8 weeks
Secondary outcomes (8)
Fluid Balance
Fluid balance - intake vs output
Measured: 8 weeks
Tolerability of Drink
Taste perception Survey
Measured: 8 weeks
Quality of Life Index
Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: 8 weeks
Quality of Life Index
SF-36 Questionnaire
Measured: 8 weeks
Changes in Blood
mm Hg
Measured: 8 weeks
Changes in heart rate
Beats per minute
Measured: 8 weeks
Changes in Lactulose-Mannitol Test
The standard test for leaky gut syndrome
Measured: 8 weeks
Immune Response based on Cytokine Levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start12 Apr 2018
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Why it stopped: Suboptimal accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entrinsic Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451253
- Sponsor's protocol ID
- 2017P000097
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2018
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03451253
- Acronym / sponsor ID
- 2017P000097
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suboptimal accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Entrinsic Bioscience Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.
| Arm | Type | Receives |
|---|---|---|
| amino acid mixture beverage | Experimental | Other: amino acid mixture beverageamino 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 | Other: glucose-based sports drinkglucose based hydration beverage. It will be given 8oz, twice daily for the first 4 weeks of randomized blinded intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Colectomy with ileostomy
- 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
Key exclusion criteria (9 listed)
- Chronic renal insufficiency glomerular filtration rate (GFR) < 40
- Significant chronic liver disease altering fluid balance
- Uncontrolled flare of inflammatory disease
- Diabetes
- Use of Lactulose/Mannitol solution is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amino acid mixture beverageAlso: enteradecommercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring. | Other | amino acid mixture beverage |
| glucose-based sports drinkAlso: GatoradeCommercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring. | Other | glucose based sports drink |
Primary outcome
GI output
Time frame: total 8 weeks
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
8 secondary outcomes
Fluid Balance
Time frame: 8 weeks
Tolerability of Drink
Time frame: 8 weeks
Quality of Life Index
Time frame: 8 weeks
Quality of Life Index
Time frame: 8 weeks
Changes in Blood
Time frame: 8 weeks
Changes in heart rate
Time frame: 8 weeks
Changes in Lactulose-Mannitol Test
Time frame: 8 weeks
Immune Response based on Cytokine Levels
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Suboptimal accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amino acid mixture beverage and glucose-based sports drink in people with Inflammatory Bowel Diseases and Short Bowel Syndrome, run by Entrinsic Bioscience Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Suboptimal accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI output (time frame: total 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.