Short Bowel SyndromePhase 4DPP-4NCT02653131
The Use of DPP-4 Inhibitors in Short Bowel Syndrome
A Phase 4 study testing Dipeptidyl peptidase-4 inhibitor in people with Short Bowel Syndrome, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
Trial summary
The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Dipeptidyl peptidase-4 inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2016to Apr 2020
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving home parenteral nutrition (HPN) because of short bowel syndrome for at least 12 months
- stable metabolic status
- benign disease
Who cannot join
- HPN < 12 months
- metabolically unstable
- cancer as the reason for intestinal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Dipeptidyl Peptidase-4 Inhibitor Influences the Absorption of Intestine in Short Bowel Syndrome
The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.
Read the detailed description
The only effective (to some extend drug) in short bowel syndrome is Glucacone-like peptide 4. Its price is, however, to high to really change the treatment strategy for intestinal failure. The Dipeptidyl peptidase-4 inhibitor, which a drug which is commonly used in the treatment of diabetes mellitus type II, should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.
- Conditions
- Short Bowel Syndrome
- Being tested
- Dipeptidyl peptidase-4 inhibitor
- Keywords
- Short bowel syndrome
- 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.
Dipeptidyl peptidase-4 inhibitorDrug
Also called Sitagliptin
| Study group | Role | What they receive |
|---|---|---|
| DPP-4 | Experimental | The administration of the DPP-4 inhibitor in the form of a pill once per day Receives: Drug: Dipeptidyl peptidase-4 inhibitor |
| NO DPP | No intervention | no therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of intestinal absorption
the use of DPP-4 inhibitor results in the better intestinal absorption
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2020
- Study completionApr 2020
Why it stopped: too many side-effects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanley Dudrick's Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaw Klek, Stanley Dudrick's Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653131
- Sponsor's protocol ID
- GLP-1
- Acronym
- DPP-4
- Status last verified
- Apr 2020
- First submitted
- 10 Jan 2016
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: All data is a part of a research
Publications
Jeppesen PB. Pharmacologic options for intestinal rehabilitation in patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):45S-52S. doi: 10.1177/0148607114526241. Epub 2014 Mar 10.
PubMed 24615689
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Dipeptidyl Peptidase-4 Inhibitor Influences the Absorption of Intestine in Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02653131
- Acronym / sponsor ID
- DPP-4 / GLP-1
- Conditions
- Short Bowel Syndrome
- Keywords
- Short bowel syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too many side-effects
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stanley Dudrick's Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 12 Jan 2016 (estimated)
- 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.
The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.
Detailed description
The only effective (to some extend drug) in short bowel syndrome is Glucacone-like peptide 4. Its price is, however, to high to really change the treatment strategy for intestinal failure. The Dipeptidyl peptidase-4 inhibitor, which a drug which is commonly used in the treatment of diabetes mellitus type II, should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPP-4 | Experimental | Drug: Dipeptidyl peptidase-4 inhibitorThe administration of the DPP-4 inhibitor in the form of a pill once per day |
| NO DPP | No intervention | –no therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients receiving home parenteral nutrition (HPN) because of short bowel syndrome for at least 12 months
- stable metabolic status
- benign disease
Key exclusion criteria (3 listed)
- HPN < 12 months
- metabolically unstable
- cancer as the reason for intestinal failure
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 |
|---|---|---|
| Dipeptidyl peptidase-4 inhibitorAlso: Sitagliptin | Drug | DPP-4 |
Primary outcome
Improvement of intestinal absorption
Time frame: 12 months
the use of DPP-4 inhibitor results in the better intestinal absorption
Results and safety
The study was stopped early (reason given: too many side-effects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Background: PubMed 24615689Jeppesen PB. Pharmacologic options for intestinal rehabilitation in patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):45S-52S. doi: 10.1177/0148607114526241. Epub 2014 Mar 10.
- Individual participant dataSharing planned: No. All data is a part of a research
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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?
A Phase 4 study testing Dipeptidyl peptidase-4 inhibitor in people with Short Bowel Syndrome, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
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 3 inclusion and 3 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 15 Apr 2020. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: too many side-effects). 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?
Improvement of intestinal absorption (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653131, which also lists 1 linked publication.
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 15 Apr 2020.