Clinical trial NCT02889393: Teduglutide for Enterocutaneous Fistula (ECF)
Official title: Teduglutide for Treatment of Enterocutaneous Fistula (ECF) - a Pilot Study to Demonstrate Safety and Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Fistula
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2016-09-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Teduglutide is safe and feasible to be given for the treatment of enterocutaneous fistula (ECF). The hypothesis is that the drug will be well tolerated and will improve the volume of daily ECF output as well as improve the functional quality of life.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia

Exclusion Criteria:

* Perianal fistula
* Clinical suspicion of inflammatory bowel disease
* History of radiation enteritis or sprue (as defined by history)
* Active (\<1 year) alcohol or drug abuse
* Significant hepatic, or cardiac diseases as defined as:
* Hepatic: aspartate aminotransferase (AST) \> 2 times upper limit of normal (10-40 U/L)
* Cardiac: unstable angina or evidence of active myocardial ischemia (elevated troponin level drawn by clinical suspicion)
* Severe renal dysfunction: serum creatinine \> 2 times upper limit of normal (0.6-1.5 mg/dL)
* Received glutamine less than 4 weeks prior to screening
* Receiving growth factors (erythropoietin, granulocyte colony-stimulating factor, granulo-cyte-macrophage colony stimulating factor, and human growth hormone)
* Pregnancy or lactation (women of childbearing age will be excluded if they do not agree to either complete sexual abstinence during the study or if they refuse to use at least two forms of highly effective contraception such as oral contraception, injectable or implantable contraception, vaginal rings, or intrauterine devices (IUD))
* Active malignancy or suspicion for gastrointestinal malignancy on CT scan
* Not capable of understanding or not willing to adhere to the study visit schedule and drug administration requirements
* Family history of intestinal malignancy (gastric, small intestine, colon)
* Personal or family history of hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, first degree relative with colon cancer
* Positive hemoccult (per rectum)
* Abnormal baseline electrocardiogram (ECF) suggestive of congestive heart failure or underlying cardiac disease
* Taking oral benzodiazepines, barbiturates, or phenothiazines

Primary outcomes:
measure: Change in Average 3-day Fistula Percent Volume
timeFrame: Baseline, Up to 8 weeks
Secondary outcomes:
measure: Number of Participants With Ceased Fistula Output
timeFrame: Up to 16 weeks
measure: Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form
timeFrame: Up to 16 weeks
measure: Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form
timeFrame: Up to 16 weeks
measure: Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health
timeFrame: Up to 16 weeks
measure: Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a
timeFrame: Up to 16 weeks
measure: Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a
timeFrame: Up to 16 weeks
measure: Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a
timeFrame: Up to 16 weeks
measure: Quality of Life as Measured by the PROMIS Scale v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Daniel D Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeppesen PB, Lund P, Gottschalck IB, Nielsen HB, Holst JJ, Mortensen J, Poulsen SS, Quistorff B, Mortensen PB. Short bowel patients treated for two years with glucagon-like Peptide 2: effects on intestinal morphology and absorption, renal function, bone and body composition, and muscle function. Gastroenterol Res Pract. 2009;2009:616054. doi: 10.1155/2009/616054. Epub 2009 Aug 20.
citation: Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.
citation: Yeh DD, Vasileiou G, Abdul Jawad K, Pust GD, Byers PM. Teduglutide for the treatment of low-output enterocutaneous fistula - A pilot randomized controlled study. Clin Nutr ESPEN. 2022 Aug;50:49-55. doi: 10.1016/j.clnesp.2022.04.031. Epub 2022 May 12.