DRUG
Teduglutide
Daily 0.05 mg/kg Teduglutide administered subcutaneously.
Teduglutide for Enterocutaneous Fistula (ECF)
Status
Completed
Phase
Phase 2
Enrollment
6
Locations
1
Results
Posted
Publications
3
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
OTHER
Standard of Care
The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion.
Timeline
From registration to results.
First posted
Sep 5, 2016
Study start
Jan 31, 2019
Primary completion
Jul 15, 2020
Study completion
Jul 15, 2021
Results posted
Oct 6, 2021
Registry updated
Oct 6, 2021
Outcomes
What the study measures.
Primary outcomes
Change in Average 3-day Fistula Percent Volume
Time frame · Baseline, Up to 8 weeks
Percent fistula volume will be reported from the participant
Secondary outcomes
Number of Participants With Ceased Fistula Output
Time frame · Up to 16 weeks
As evaluated by treating physician of having at least 1 ceased fistula output
Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form
Time frame · Up to 16 weeks
Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Social Functioning - Short Form questionnaire has a total score ranging from 5-25 with the higher score indicating a healthier status.
Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form
Time frame · Up to 16 weeks
Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Sleep Impact - Short Form questionnaire has a total score ranging from 5-25 with the higher score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health
Time frame · Up to 16 weeks
Patient Reported Outcome Measures Information Systems Global Health has a total score ranging from 10-50 with the higher score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a
Time frame · Up to 16 weeks
Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Belly Pain 5a questionnaire has a total score ranging from 1-25 with the lower score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a
Time frame · Up to 16 weeks
Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Diarrhea 6a questionnaire has a total score ranging from 1-30 with the lower score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a
Time frame · Up to 16 weeks
Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Nausea and Vomiting 4a questionnaire has a total score ranging from 1-20 with the lower score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a
Time frame · Up to 16 weeks
Patient Reported Outcome Measures Information Systems (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 8a questionnaire has a total score ranging from 8-40 with the lower score indicating a healthier status
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Miami
Miami, Florida, United States
Publications
Results and literature.
PMID 19707516 ↗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.PMID 21317170 ↗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.PMID 35871951 ↗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.
Related trials
More studies on Teduglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
Takeda · Short Bowel Syndrome
Phase 3
Recruiting
13
2026-06
Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
International Centre for Diarrhoeal Disease Research, Bangladesh · Environmental Enteric Dysfunction
Phase 2
Not yet recruiting
55
2026-04
A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Takeda · Short Bowel Syndrome
Not applicable
Active, not recruiting
250
2026-04
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
12
2026-03
TED_ORG: Study on Short Bowel Syndrome
Meyer Children's Hospital IRCCS · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
50
2026-02
A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
600
2026-01
Registry for Participants With Short Bowel Syndrome
Shire · Short Bowel Syndrome
Not applicable
Active, not recruiting
1,806
2025-10
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
Assistance Publique - Hôpitaux de Paris · Short Bowel Syndrome
Phase 4
Completed
25
2025-09
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.