Colitis, UlcerativeNCT03460847
Fecal Microbiota Alterations in Steroid Refractory Active Colitis Ulcerosa
An observational study of Colitis, Ulcerative, run by Medical University of Graz at 1 site in Austria.
Trial summary
Alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often leads to an unfavourable course in patients suffering from this disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Steroids
- How many people
- 114 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2018to 1 Mar 2021
- 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
- Adult, Older adult
Study population: Patients suffering from an active colitis ulcerosa and requiring steroids as therapy.
Who may be able to join
- Active ulcerative colitis with a Lichtiger score ≥4
- Patient scheduled for steroid therapy with systemic steroids (prednisolone or methylprednisolone) at standard dosing and patients who started steroid therapy not longer than 48 hours prior to the study inclusion.
- Written informed consent
- Established or suspected diagnosis of ulcerative colitis or indeterminate colitis
Who cannot join
- No follow up possible
- Bacterial intestinal infections (C. difficile, Salmonella, EHEC, Campylobacter, Shigella, Yersinia), parasitic or viral infection causing acute infectious diarrhea at baseline.
- Diagnosis of Crohn´s disease
- Planned initiation or discontinuation of probiotic therapy between baseline and follow up visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Fecal Microbiota Alterations Predict a Refractory Disease Course to Standard Steroid Therapy in Patients With Active Ulcerative Colitis?
Alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often leads to an unfavourable course in patients suffering from this disorder. This study proposal aims at investigating changes in the intestinal microbiota that can predict a therapy refractory course of ulcerative colitis (UC) and may be used to identify high risk patients in an early phase of their disease.
Read the detailed description
The Investigators suggest that certain alterations in the intestinal microbiota are at least in part responsible for the inability of some patients to response to steroid therapy and probably also for the failure to other immunosuppressive therapies. Certain pathobionts have the capability to stimulate the mucosal immune system, thereby leading to chronic inflammation. On the other hand, commensals are necessary for repair processes in the mucosa and are providing metabolites that are used as an energy source for the colonic epithelium. An increase in pathobionts in combination with a lack of certain commensals might therefore maintain colonic inflammation despite immunosuppressive therapy with systemic steroids in patients with UC.
The investigators therefore plan to investigate the intestinal microbiota in UC patients before and 4 weeks after a systemic corticosteroid therapy and correlate potential alterations of the microbiota to the therapeutic response. Other factors like concomitant UC treatment, disease severity, disease extent and environmental factors will also be correlated to changes in the microbiota.
In the subgroup of patients not responding to steroids and requiring a rescue therapy with infliximab or a calcineurin Inhibitor, the predictive value of microbiota alterations will also be investigated.
If certain bacterial taxa can predict a steroid refractory and an unfavorable disease course, the results of this study will help in identifying possible microbiota based biomarkers for an individualized treatment approach in UC patients in the future.
- Conditions
- Colitis, Ulcerative
- Being tested
- Steroids
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteroidsDrug
Also called Aprednisolon, Prednisolut
Patients with active colitis ulcerosa who need steroids because of their disease course. 1mg/kg bodyweight for one week, followed by a tapping periode.
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota alterations
To assess if alterations of the fecal microbiota are associated with a failure to respond to steroid therapy within 28 days in patients with ulcerative colitis. The microbiota will be assessed by 16s RNA analysis.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Mar 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Hoegenauer, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460847
- Sponsor's protocol ID
- 29-316 ex 16/17
- Status last verified
- Sep 2021
- First submitted
- 22 Feb 2018
- Last updated
- 8 Sep 2021
- 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 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Fecal Microbiota Alterations Predict a Refractory Disease Course to Standard Steroid Therapy in Patients With Active Ulcerative Colitis?
- ClinicalTrials.gov ID
- NCT03460847
- Acronym / sponsor ID
- 29-316 ex 16/17
- Conditions
- Colitis, Ulcerative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 9 Mar 2018 (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.
Alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often leads to an unfavourable course in patients suffering from this disorder. This study proposal aims at investigating changes in the intestinal microbiota that can predict a therapy refractory course of ulcerative colitis (UC) and may be used to identify high risk patients in an early phase of their disease.
Detailed description
The Investigators suggest that certain alterations in the intestinal microbiota are at least in part responsible for the inability of some patients to response to steroid therapy and probably also for the failure to other immunosuppressive therapies. Certain pathobionts have the capability to stimulate the mucosal immune system, thereby leading to chronic inflammation. On the other hand, commensals are necessary for repair processes in the mucosa and are providing metabolites that are used as an energy source for the colonic epithelium. An increase in pathobionts in combination with a lack of certain commensals might therefore maintain colonic inflammation despite immunosuppressive therapy with systemic steroids in patients with UC.
The investigators therefore plan to investigate the intestinal microbiota in UC patients before and 4 weeks after a systemic corticosteroid therapy and correlate potential alterations of the microbiota to the therapeutic response. Other factors like concomitant UC treatment, disease severity, disease extent and environmental factors will also be correlated to changes in the microbiota.
In the subgroup of patients not responding to steroids and requiring a rescue therapy with infliximab or a calcineurin Inhibitor, the predictive value of microbiota alterations will also be investigated.
If certain bacterial taxa can predict a steroid refractory and an unfavorable disease course, the results of this study will help in identifying possible microbiota based biomarkers for an individualized treatment approach in UC patients in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from an active colitis ulcerosa and requiring steroids as therapy.
Key inclusion criteria (4 listed)
- Active ulcerative colitis with a Lichtiger score ≥4
- Patient scheduled for steroid therapy with systemic steroids (prednisolone or methylprednisolone) at standard dosing and patients who started steroid therapy not longer than 48 hours prior to the study inclusion.
- Written informed consent
- Established or suspected diagnosis of ulcerative colitis or indeterminate colitis
Key exclusion criteria (4 listed)
- No follow up possible
- Bacterial intestinal infections (C. difficile, Salmonella, EHEC, Campylobacter, Shigella, Yersinia), parasitic or viral infection causing acute infectious diarrhea at baseline.
- Diagnosis of Crohn´s disease
- Planned initiation or discontinuation of probiotic therapy between baseline and follow up visit
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 |
|---|---|---|
| SteroidsAlso: Aprednisolon, PrednisolutPatients with active colitis ulcerosa who need steroids because of their disease course. 1mg/kg bodyweight for one week, followed by a tapping periode. | Drug | – |
Primary outcome
Microbiota alterations
Time frame: 28 days
To assess if alterations of the fecal microbiota are associated with a failure to respond to steroid therapy within 28 days in patients with ulcerative colitis. The microbiota will be assessed by 16s RNA analysis.
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 8 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Christoph Hoegenauer, Prof. principal investigator
Medical University of Graz
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 Colitis, Ulcerative, run by Medical University of Graz at 1 site in Austria.
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 4 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 8 Sep 2021. 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 Austria. 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?
Microbiota alterations (time frame: 28 days). 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 8 Sep 2021.