Short Bowel SyndromeNCT06102668
Survival and PN Dependence in SBS Patients
An observational study of Short Bowel Syndrome, run by The First Affiliated Hospital of University of Science and Technology of China.
Trial summary
Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The objective of this study was to determine the longterm survival and parenteral nutrition dependence of adult patients with SBS. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Short Bowel Syndrome
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jan 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with SBS caused by extensive bowel resection with a remnant small intestine length of <200cm.
Who may be able to join
- Adult patients diagnosed with SBS.
Who cannot join
- age <18 years; patients with active malignant tumors.
About this study
Official title: Long-term Survival and Parenteral Nutrition Dependence in Adult Patients With Non-malignant Short Bowel Syndrome
Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The objective of this study was to determine the longterm survival and parenteral nutrition dependence of adult patients with SBS.
Read the detailed description
Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. Patients with SBS often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. SBS can cause various metabolic and physiologic disturbances. Although parenteral nutrition is a life-saving measure for many patients with SBS, patients with SBS is associated with decreased survival and parenteral nutrition (PN) dependence. Few studies have reported the survival and PN dependence in adult SBS patients in China.
- Conditions
- Short Bowel Syndrome
- Medical subject headings
- Short Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival rate in patients with SBS
Measured: 2012/1/1-2019/1/1
Parenteral nutrition dependence
Parenteral nutrition dependence in patients with SBS
Measured: 2012/1/1-2019/1/1
Secondary outcomes (2)
Risk factors
Risk factors of mortality and parenteral dependence in patients with SBS
Measured: 2012/1/1-2019/1/1
Cause of death
Cause of death in patients with SBS at the end of follow-up
Measured: 2012/1/1-2019/1/1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2012
- Primary completion1 Jan 2019
- Study completion1 Jan 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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Collaborators
- Jinling Hospital, China
- Responsible party
- Sponsor
- Investigators
- JIANFENG GONG, M.D., Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102668
- Sponsor's protocol ID
- FirstAHUSTChina
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival and Parenteral Nutrition Dependence in Adult Patients With Non-malignant Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06102668
- Acronym / sponsor ID
- FirstAHUSTChina
- Conditions
- Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Collaborators
- Jinling Hospital, China
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 26 Oct 2023 (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.
Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The objective of this study was to determine the longterm survival and parenteral nutrition dependence of adult patients with SBS.
Detailed description
Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. Patients with SBS often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. SBS can cause various metabolic and physiologic disturbances. Although parenteral nutrition is a life-saving measure for many patients with SBS, patients with SBS is associated with decreased survival and parenteral nutrition (PN) dependence. Few studies have reported the survival and PN dependence in adult SBS patients in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SBS caused by extensive bowel resection with a remnant small intestine length of <200cm.
Key inclusion criteria (1 listed)
- Adult patients diagnosed with SBS.
Key exclusion criteria (1 listed)
- age <18 years; patients with active malignant tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 2012/1/1-2019/1/1
Survival rate in patients with SBS
Parenteral nutrition dependence
Time frame: 2012/1/1-2019/1/1
Parenteral nutrition dependence in patients with SBS
2 secondary outcomes
Risk factors
Time frame: 2012/1/1-2019/1/1
Cause of death
Time frame: 2012/1/1-2019/1/1
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 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Short Bowel Syndrome
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
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Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
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A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
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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.
JIANFENG GONG, M.D. principal investigator
Jinling Hospital, China
Questions about this trial
What is this clinical trial studying?
An observational study of Short Bowel Syndrome, run by The First Affiliated Hospital of University of Science and Technology of 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 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Survival (time frame: 2012/1/1-2019/1/1). The study lists 2 primary outcomes in all. 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 26 Oct 2023.