Short Bowel SyndromeOXAGONCT04119765
Plasma Oxalate in Patient With Short Bowel
An observational study of Short Bowel Syndrome and Hyperoxaluria, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome, Hyperoxaluria, Hyperoxalemia
- What is being tested?
- Blood sampling, Urine sampling and Pulse Wave Velocity (PWV) measurement
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2020to 4 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type II short bowel patient
Who may be able to join
- Age ≥ 18 years
- Type II short bowel for more than 6 months
- Affiliated to a social health care
Who cannot join
- Primary hyperoxaluria
- Other type of short bowel than type II
- Minor patient or major patient protected by the law
Trial locations and contacts
1 site in 1 country.
About this study
Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.
- Conditions
- Short Bowel Syndrome, Hyperoxaluria, Hyperoxalemia
- Being tested
- Blood sampling, Urine sampling, Pulse Wave Velocity (PWV) measurement, central pressure measurement
- Medical subject headings
- Short Bowel Syndrome, Hyperoxaluria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
blood sampling will be used to perform oxalemia and FGF23 quantitative analysis
Urine samplingBiological
urine sampling will be used to measure glycolate urinary rate (glycolaturia) and to perform urinary inflammation markers quantitative analysis
Pulse Wave Velocity (PWV) measurementProcedure or surgery
PWV will be measured thank to the Complior® device
central pressure measurementProcedure or surgery
central pressure will be measured thank to the Complior® device
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma oxalate rate (oxalemia)
this sample measures the plasma oxalate rate
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start27 Feb 2020
- Primary completion4 May 2022
- Study completion4 May 2022
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 Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine Lemoine, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119765
- Sponsor's protocol ID
- 69HCL18_0408
- Acronym
- OXAGO
- Status last verified
- Jul 2022
- First submitted
- 7 Oct 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Oxalate in Patient With Short Bowel
- ClinicalTrials.gov ID
- NCT04119765
- Acronym / sponsor ID
- OXAGO / 69HCL18_0408
- Conditions
- Short Bowel Syndrome, Hyperoxaluria, Hyperoxalemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 8 Oct 2019 (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.
Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type II short bowel patient
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Type II short bowel for more than 6 months
- Affiliated to a social health care
Key exclusion criteria (3 listed)
- Primary hyperoxaluria
- Other type of short bowel than type II
- Minor patient or major patient protected by the law
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 |
|---|---|---|
| Blood samplingblood sampling will be used to perform oxalemia and FGF23 quantitative analysis | Biological | – |
| Urine samplingurine sampling will be used to measure glycolate urinary rate (glycolaturia) and to perform urinary inflammation markers quantitative analysis | Biological | – |
| Pulse Wave Velocity (PWV) measurementPWV will be measured thank to the Complior® device | Procedure or surgery | – |
| central pressure measurementcentral pressure will be measured thank to the Complior® device | Procedure or surgery | – |
Primary outcome
Plasma oxalate rate (oxalemia)
Time frame: at inclusion
this sample measures the plasma oxalate rate
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 21 Jul 2022.
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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.
Sandrine Lemoine, MD principal investigator
Hospices Civils de Lyon
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 and Hyperoxaluria, run by Hospices Civils de Lyon at 1 site in France.
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: finished, as of the sponsor's last update on 21 Jul 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 France. 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?
Plasma oxalate rate (oxalemia) (time frame: at inclusion). 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 21 Jul 2022.