Short Bowel Syndrome (SBS)NCT05113082
Retrospective Study on Participants With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Transplantation in Brazil
An observational study of Short Bowel Syndrome (SBS), run by Takeda at 1 site in Brazil.
Trial summary
The main aim of this study is to capture management and treatment outcome data in participants with short bowel syndrome and chronic intestinal failure (SBS-IF) that underwent intestinal transplantation in Brazil. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Short Bowel Syndrome (SBS)
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- 21 May 2022to 15 Oct 2022
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with SBS-IF that underwent intestinal transplantation in Brazil.
Who may be able to join
- Participants with a diagnosis of SBS-IF, who underwent intestinal transplantation between April 2011 to April 2021.
- Participants who have signed the informed consent form (or his/her legal representative). For deceased participants or those with lost to follow-up, an informed consent form (ICF) waiver is acceptable.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, SP 05652-900
About this study
Official title: A Multicentric Observational Retrospective Study on Patients With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Intestinal Transplantation in Brazil
The main aim of this study is to capture management and treatment outcome data in participants with short bowel syndrome and chronic intestinal failure (SBS-IF) that underwent intestinal transplantation in Brazil.
This study is about collecting data available in the participant's medical record and will also describe the demographic and clinical characteristics of these participants. No medication will be provided to participants in this study.
Clinical data will be collected from a period up to 10 years before the day of the intestinal transplantation. No clinic visits will be required as part of participation in this study.
- Conditions
- Short Bowel Syndrome (SBS)
- Keywords
- Chronic Intestinal Failure
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with SBS-IF | Participants with SBS-IF who as part of standard or routine clinical practice, that underwent intestinal transplantation over the last 10 years (both dead and alive at the time of study enrollment) will be observed in this retrospective observational study for 10 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis
Elapsed time from the date of underlying condition diagnosis to the date of SBS-IF diagnosis, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.
Measured: From start of the study up to end of observation period (up to 10 months)
Elapsed Time From the Date of SBS-IF Diagnosis to the Date of Intestinal Transplant Procedure Indication
Elapsed time from the date of SBS-IF diagnosis to the date of intestinal transplant procedure indication, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.
Measured: From start of the study up to end of observation period (up to 10 months)
Elapsed Time From the Date of Intestinal Transplant Indication to the Date of Intestinal Transplant Procedure
Elapsed time from the date of intestinal transplant indication to the date of intestinal transplant procedure, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.
Measured: From start of the study up to end of observation period (up to 10 months)
Secondary outcomes (12)
Volume of Parenteral Nutrition and Fluid (Intravenous [IV]) Support From Site Admission Until Intestinal Transplantation During Intestinal Transplantation
Volume (milliliter/day [mL/day]) of parenteral nutrition and fluid (IV) support from site admission until intestinal transplantation will be summarized using descriptive statistics. Parenteral nutrition is the feeding of nutritional products to a person intravenously, by passing the usual process of eating and digestion.
Measured: From start of the study up to end of observation period (up to 10 months)
Number of Participants With Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation
Number of participants with parenteral nutrition and fluid (IV) support from site admission until intestinal transplantation will be summarized using descriptive statistics. Number of participants with parenteral nutrition and fluid support is calculated by day/week. Parenteral nutrition is the feeding of nutritional products to a person intravenously, by passing the usual process of eating and digestion.
Measured: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Type of Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation
Number of Participants based on type (ready to use or individualized) of parenteral nutrition and fluid (IV) support from site admission until intestinal transplantation will be summarized using descriptive statistics. Parenteral nutrition is the feeding of nutritional products to a person intravenously, bypassing the usual process of eating and digestion.
Measured: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Reasons for Intestinal Transplant Indication
Number of Participants based on reasons for Intestinal Transplant Indication will be summarized using descriptive statistics.
Measured: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Each Type of Intestinal Transplant Performed
Number of participants based on each type of intestinal transplant will be summarized using descriptive statistics.
Measured: From start of the study up to end of observation period (up to 10 months)
Number of Participants With Hospitalization Related to SBS-IF Disease Since Site Admission Until Intestinal Transplantation
Number of participants with hospitalizations per patient per year will be calculated based on the number of hospitalizations during the follow-up period.
Measured: From start of the study up to end of observation period (up to 10 months)
Length of Hospitalization Related to SBS-IF Disease
Length of hospitalization (days) related to SBS-IF disease since site admission until intestinal transplantation will be summarized using descriptive statistics.
Measured: From start of the study up to end of observation period (up to 10 months)
Number of Participants With Surgery Performed in SBS-IF Participants
Number of participants with surgery performed in SBS-IF participants since site admission to intestinal transplantation will be summarized using descriptive statistics.
Measured: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Reason/Indication for Hospitalization in SBS-IF Participants
Number of participants based on reason/indication for hospitalization by SBS-IF participants since site admission to intestinal transplantation will be summarized using descriptive statistics.
Measured: From start of the study up to end of observation period (up to 10 months)
Percentage of Participants With Each Disease Leading to SBS-IF
Percentage of participants with each disease/cause leading to SBS-IF will be summarized using descriptive statistics.
Measured: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Anatomy Site
Number of participants based on anatomy site will be summarized using descriptive statistics.
Measured: From start of the study up to end of observation period (up to 10 months)
Length of the Remaining Bowel
Length of the remaining bowel will be summarized using descriptive statistics.
Measured: From start of the study up to end of observation period (up to 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start21 May 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel Syndrome (SBS)Studies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113082
- Sponsor's protocol ID
- TAK-633-4007
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Observational Retrospective Study on Patients With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Intestinal Transplantation in Brazil
- ClinicalTrials.gov ID
- NCT05113082
- Acronym / sponsor ID
- TAK-633-4007
- Conditions
- Short Bowel Syndrome (SBS)
- Keywords
- Chronic Intestinal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 21 May 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 9 Nov 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.
The main aim of this study is to capture management and treatment outcome data in participants with short bowel syndrome and chronic intestinal failure (SBS-IF) that underwent intestinal transplantation in Brazil.
This study is about collecting data available in the participant's medical record and will also describe the demographic and clinical characteristics of these participants. No medication will be provided to participants in this study.
Clinical data will be collected from a period up to 10 years before the day of the intestinal transplantation. No clinic visits will be required as part of participation in this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with SBS-IF | – | –Participants with SBS-IF who as part of standard or routine clinical practice, that underwent intestinal transplantation over the last 10 years (both dead and alive at the time of study enrollment) will be observed in this retrospective observational study for 10 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with SBS-IF that underwent intestinal transplantation in Brazil.
Key inclusion criteria (2 listed)
- Participants with a diagnosis of SBS-IF, who underwent intestinal transplantation between April 2011 to April 2021.
- Participants who have signed the informed consent form (or his/her legal representative). For deceased participants or those with lost to follow-up, an informed consent form (ICF) waiver is acceptable.
Key exclusion criteria (0 listed)
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
Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis
Time frame: From start of the study up to end of observation period (up to 10 months)
Elapsed time from the date of underlying condition diagnosis to the date of SBS-IF diagnosis, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.
Elapsed Time From the Date of SBS-IF Diagnosis to the Date of Intestinal Transplant Procedure Indication
Time frame: From start of the study up to end of observation period (up to 10 months)
Elapsed time from the date of SBS-IF diagnosis to the date of intestinal transplant procedure indication, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.
Elapsed Time From the Date of Intestinal Transplant Indication to the Date of Intestinal Transplant Procedure
Time frame: From start of the study up to end of observation period (up to 10 months)
Elapsed time from the date of intestinal transplant indication to the date of intestinal transplant procedure, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.
12 secondary outcomes
Volume of Parenteral Nutrition and Fluid (Intravenous [IV]) Support From Site Admission Until Intestinal Transplantation During Intestinal Transplantation
Time frame: From start of the study up to end of observation period (up to 10 months)
Number of Participants With Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation
Time frame: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Type of Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation
Time frame: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Reasons for Intestinal Transplant Indication
Time frame: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Each Type of Intestinal Transplant Performed
Time frame: From start of the study up to end of observation period (up to 10 months)
Number of Participants With Hospitalization Related to SBS-IF Disease Since Site Admission Until Intestinal Transplantation
Time frame: From start of the study up to end of observation period (up to 10 months)
Length of Hospitalization Related to SBS-IF Disease
Time frame: From start of the study up to end of observation period (up to 10 months)
Number of Participants With Surgery Performed in SBS-IF Participants
Time frame: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Reason/Indication for Hospitalization in SBS-IF Participants
Time frame: From start of the study up to end of observation period (up to 10 months)
Percentage of Participants With Each Disease Leading to SBS-IF
Time frame: From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Anatomy Site
Time frame: From start of the study up to end of observation period (up to 10 months)
Length of the Remaining Bowel
Time frame: From start of the study up to end of observation period (up to 10 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 29 Nov 2022.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
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 (SBS), run by Takeda at 1 site in Brazil.
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 2 inclusion and 0 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 29 Nov 2022. 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 Brazil. 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?
Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis (time frame: From start of the study up to end of observation period (up to 10 months)). The study lists 3 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 29 Nov 2022.