Short Bowel SyndromePhase 4NCT01974336
The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients
A Phase 4 study testing ursodeoxycholic acid in people with Short Bowel Syndrome, run by Jinling Hospital, China at 1 site in China.
Trial summary
The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- ursodeoxycholic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Sep 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with short bowel syndrome supported by total parenteral nutrition.
- Patients have intestine more than 50cm.
- Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- Consciousness and ability to cooperate.
Who cannot join
- Patients have obstruction of biliary tract, infection, autoimmune disease, cancer
- Patients have intestine less than 50cm
- A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease
- Female with positive pregnancy
- Allergy to ursodeoxycholic acid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Parenteral Nutrition-associated Cholestasis in Short Bowel Syndrome
The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in adults with short bowel syndrome.
- Conditions
- Short Bowel Syndrome
- Being tested
- ursodeoxycholic acid
- 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.
ursodeoxycholic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| UDCA+placebo group | Experimental | 15-30mg/kg/d UDCA for 2 months + placebo for 2 months Receives: Drug: ursodeoxycholic acid |
| placebo+UDCA | Experimental | placebo for 2 months+15-30mg/kg/d UDCA for 2 months Receives: Drug: ursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The biochemical indicator of patients' liver function during oral UDCA or placebo
detect the biochemical indicator of patients' liver function(Serum bilirubin, GGT Valley, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase) during oral UDCA or placebo
Measured: 2 months
Secondary outcomes (2)
the changs of composition of serum bile acid after oral UDCA or placebo
we test the composition of serum bile acid at the beginning,2 months,4 months(the end) of the trial
Measured: 2 months
The changs of the level of fibroblast growth factor 19(FGF19) in the serum
we test the level of FGF19 in the serum at the beginning,2 months,4months(the end) of the trail.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2016
- Study completionSep 2016
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Kong Wencheng, Jinling Hospital, China
- Investigators
- Wencheng Kong, MD, Principal investigator, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974336
- Sponsor's protocol ID
- UDCA-PNAC-SBS
- Status last verified
- Feb 2017
- First submitted
- 20 Oct 2013
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Parenteral Nutrition-associated Cholestasis in Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01974336
- Acronym / sponsor ID
- UDCA-PNAC-SBS
- Conditions
- Short Bowel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Jan 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Nov 2013 (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 efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in adults with short bowel syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UDCA+placebo group | Experimental | Drug: ursodeoxycholic acid15-30mg/kg/d UDCA for 2 months + placebo for 2 months |
| placebo+UDCA | Experimental | Drug: ursodeoxycholic acidplacebo for 2 months+15-30mg/kg/d UDCA for 2 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with short bowel syndrome supported by total parenteral nutrition.
- Patients have intestine more than 50cm.
- Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- Consciousness and ability to cooperate.
Key exclusion criteria (5 listed)
- Patients have obstruction of biliary tract, infection, autoimmune disease, cancer
- Patients have intestine less than 50cm
- A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease
- Female with positive pregnancy
- Allergy to ursodeoxycholic acid
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 |
|---|---|---|
| ursodeoxycholic acid | Drug | UDCA+placebo group, placebo+UDCA |
Primary outcome
The biochemical indicator of patients' liver function during oral UDCA or placebo
Time frame: 2 months
detect the biochemical indicator of patients' liver function(Serum bilirubin, GGT Valley, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase) during oral UDCA or placebo
2 secondary outcomes
the changs of composition of serum bile acid after oral UDCA or placebo
Time frame: 2 months
The changs of the level of fibroblast growth factor 19(FGF19) in the serum
Time frame: 4 months
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 24 Feb 2017.
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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.
Wencheng Kong, MD principal investigator
Nanjing University
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 ursodeoxycholic acid in people with Short Bowel Syndrome, run by Jinling Hospital, China at 1 site in China.
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 4 inclusion and 5 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 24 Feb 2017. 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 China. 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 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?
The biochemical indicator of patients' liver function during oral UDCA or placebo (time frame: 2 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 24 Feb 2017.