An interventional study of amino acid mixture beverage and glucose-based sports drink in Inflammatory Bowel Diseases, Short Bowel Syndrome and Ileostomy - Stoma, sponsored by Entrinsic Bioscience Inc.. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Entrinsic Bioscience Inc. · Not applicable, Interventional, and Other
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.
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.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's enrollment of 7 is below the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Entrinsic Bioscience Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Colectomy with ileostomy
a. Ileostomy alone with less than 30 cm of small bowel resected i. A diverting ileostomy is permitted
Any of the following:
Exclusion:
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
Current Diagnosis of Cancer
a. May be included if they are 4 or more months out from cancer therapy (i.e. chemotherapy, etc.)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 hydration beverage. It will be given 8oz, twice daily for the first 4 weeks of randomized blinded intervention.
Other: glucose-based sports drink
commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.
Also known as: enterade
Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.
Also known as: Gatorade
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
Time frame: total 8 weeks
Fluid Balance
Fluid balance - intake vs output
Time frame: 8 weeks
Tolerability of Drink
Taste perception Survey
Time frame: 8 weeks
Quality of Life Index
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: 8 weeks
Quality of Life Index
SF-36 Questionnaire
Time frame: 8 weeks
Changes in Blood
mm Hg
Time frame: 8 weeks
Changes in heart rate
Beats per minute
Time frame: 8 weeks
Changes in Lactulose-Mannitol Test
The standard test for leaky gut syndrome
Time frame: 8 weeks
Immune Response based on Cytokine Levels
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Entrinsic Bioscience Inc.