Short Bowel SyndromeNCT04916665
Bridging Intestinal Failure With Teduglutide - a Case Report
An observational study of Short Bowel Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In this case report the investigators present a novel strategy for using teduglutide as a bridging therapy to intestinal reconstruction. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Teduglutide
- How many people
- 1 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Observational
- 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 Any age
- Men only
- Child, Adult, Older adult
Study population: case report
Who may be able to join
- short bowel syndrome
Who cannot join
- <18 years
Trial locations and contacts
1 site in 1 country.
About this study
In this case report the investigators present a novel strategy for using teduglutide as a bridging therapy to intestinal reconstruction.
- Conditions
- Short Bowel Syndrome
- Being tested
- Teduglutide
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeduglutideDrug
bridging intestinal failure with teduglutide until reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
enteral autonomy (complete discontinuation of parenteral support)
observe if enteral autonomy may be achieved before reconstruction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Harpain, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916665
- Sponsor's protocol ID
- 8745632
- Status last verified
- Jun 2021
- First submitted
- 30 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- 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 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Intestinal Failure With Teduglutide - a Case Report
- ClinicalTrials.gov ID
- NCT04916665
- Acronym / sponsor ID
- 8745632
- Conditions
- Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Jun 2021 (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.
In this case report the investigators present a novel strategy for using teduglutide as a bridging therapy to intestinal reconstruction.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- case report
Key inclusion criteria (1 listed)
- short bowel syndrome
Key exclusion criteria (1 listed)
- <18 years
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 |
|---|---|---|
| Teduglutidebridging intestinal failure with teduglutide until reconstruction | Drug | – |
Primary outcome
enteral autonomy (complete discontinuation of parenteral support)
Time frame: 6 months
observe if enteral autonomy may be achieved before reconstruction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Bowel Syndrome, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
enteral autonomy (complete discontinuation of parenteral support) (time frame: 6 months). 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 7 Jun 2021.