Inflammatory Bowel DiseasesERIcaNCT05157750
Endoscopic Remission, Histologic Remission and Barrier Healing for Predicting Disease Behaviour in IBD
An observational study of Inflammatory Bowel Diseases, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Within this study, the investigators aim to directly compare the value of endoscopic remission, histologic remission and barrier healing for predicting long-term disease behavior in a large cohort of clinically remittent IBD patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Recording of major clinical events
- Type of treatment
- Injection or infusion
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2017to 1 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 to 99 years
- All sexes
- Adult, Older adult
Study population: Consecutive patients with an established IBD diagnosis for at least 12 months duration presenting in clinical remission presenting at the Department of Gastroenterology of the University Hospital Erlangen will be prospectively included.
Who may be able to join
- patients with an established IBD diagnosis for at least 12 months duration
- IBD patients in clinical remission
Who cannot join
- patients with poor bowel preparation
- patients with total colectomy,
- patients with concomitant beta blocker therapy,
- patients with known allergy to fluorescein
- patients with a planned change in IBD-related pharmacotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, 91054
Timo Rath, M.D., 49 9131 ext. 85 45041, timo.rath@uk-erlangen.de
About this study
Official title: Direct Comparison of Endoscopic and Histologic Remission and Barrier Healing for Predicting Long Term Disease Behaviour in Clinically Remittent IBD Patients: the Prospective ERIca Study
Within this study, the investigators aim to directly compare the value of endoscopic remission, histologic remission and barrier healing for predicting long-term disease behavior in a large cohort of clinically remittent IBD patients.
Read the detailed description
Mucosal healing is a key therapeutic goal in the management of patients with inflammatory bowel diseases (IBD) that is associated with favorable long-term disease outcome. In addition, histologic remission is an emerging endpoint and first data suggest that functional assessment of the integrity of the intestinal barrier, i.e. barrier healing, by confocal laser endomicroscopy (CLE) correlates to clinical disease behavior and outcome.
Within this study, the investigators will prospectively include IBD patients in clinical remission and assess endoscopic remission, histologic remission and barrier healing during baseline ileocolonoscopy. Participants will then be closely followed up in the IBD outpatient department of the University Hospital Erlangen every 4 to 8 weeks for participants under biological therapy and every 8 weeks for participants under conventional therapy. At each visit, clinical disease activity using the Mayo Clinical Score (MCS) and the Crohn's disease activity Index (CDAI), respectively, routine laboratory parameters and current and past medications will be recorded. Further, at each visit, major clinical events (MCE), defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded. The primary endpoint of this study is to comparatively assess the predictive values of barrier healing, endoscopic remission and histologic remission for predicting occurrence of MCE in IBD patients in clinical remission
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Recording of major clinical events
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of major clinical eventsOther
During follow-up, major clinical events, defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients with endoscopic remission | No intervention will be administered. All patients with endoscopic remission will be monitored for the future development of major clinical events. Diagnostic performances of endoscopic remission for predicting major clinical events will be calculated. Receives: Other: Recording of major clinical events | |
| IBD patients with histologic remission | No intervention will be administered. All patients with histologic remission will be monitored for the future development of major clinical events. Diagnostic performances of histologic remission for predicting major clinical events will be calculated. Receives: Other: Recording of major clinical events | |
| IBD patients with barrier healing | No intervention will be administered. All patients with barrier healing will be monitored for the future development of major clinical events. Diagnostic performances of barrier healing for predicting major clinical events will be calculated. Receives: Other: Recording of major clinical events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of endoscopic remission in ulcerative colitis
Endoscopic remission will be assessed using the Mayo Endoscopy Score in ulcerative colitis
Measured: 2 years
Predictive value of endoscopic remission in Crohn's disease
Endoscopic remission will be assessed using the simplified endoscopic index of severity (SES-CD) in Crohn's disease
Measured: 2 years
Predictive value of histologic remission in ulcerative colitis
Histologic remission will be assessed using the Robarts Histology Index and the Nancy Histology Index in ulcerative colitis
Measured: 2 years
Predictive value of histologic remission in Crohn's disease
Histologic remission will be assessed using a modified Riley Score in Crohn's disease
Measured: 2 years
Predictive value of barrier healing
Barrier healing will be assessed using the well-established Watson-Score as a semiquantitative grading system of the intestinal barrier function
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start16 Jan 2017
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timo Rath, University of Erlangen-Nürnberg Medical School
- Investigators
- Timo Rath, MD, Principal investigator, University Hospital Erlangen, Department of Medicine 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157750
- Sponsor's protocol ID
- ERIca Study
- Acronym
- ERIca
- Status last verified
- Dec 2021
- First submitted
- 19 Oct 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CI, Vitali F, Zundler S, Waldner MJ, Hartmann A, Neurath MF. Healing of the epithelial barrier in the ileum is superior to endoscopic and histologic remission for predicting major adverse outcomes in ulcerative colitis. Front Med (Lausanne). 2023 Oct 10;10:1221449. doi: 10.3389/fmed.2023.1221449. eCollection 2023.
PubMed 37881628Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.
PubMed 36279923
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Comparison of Endoscopic and Histologic Remission and Barrier Healing for Predicting Long Term Disease Behaviour in Clinically Remittent IBD Patients: the Prospective ERIca Study
- ClinicalTrials.gov ID
- NCT05157750
- Acronym / sponsor ID
- ERIca / ERIca Study
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 15 Dec 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.
Within this study, the investigators aim to directly compare the value of endoscopic remission, histologic remission and barrier healing for predicting long-term disease behavior in a large cohort of clinically remittent IBD patients.
Detailed description
Mucosal healing is a key therapeutic goal in the management of patients with inflammatory bowel diseases (IBD) that is associated with favorable long-term disease outcome. In addition, histologic remission is an emerging endpoint and first data suggest that functional assessment of the integrity of the intestinal barrier, i.e. barrier healing, by confocal laser endomicroscopy (CLE) correlates to clinical disease behavior and outcome.
Within this study, the investigators will prospectively include IBD patients in clinical remission and assess endoscopic remission, histologic remission and barrier healing during baseline ileocolonoscopy. Participants will then be closely followed up in the IBD outpatient department of the University Hospital Erlangen every 4 to 8 weeks for participants under biological therapy and every 8 weeks for participants under conventional therapy. At each visit, clinical disease activity using the Mayo Clinical Score (MCS) and the Crohn's disease activity Index (CDAI), respectively, routine laboratory parameters and current and past medications will be recorded. Further, at each visit, major clinical events (MCE), defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded. The primary endpoint of this study is to comparatively assess the predictive values of barrier healing, endoscopic remission and histologic remission for predicting occurrence of MCE in IBD patients in clinical remission
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD patients with endoscopic remission | – | Other: Recording of major clinical eventsNo intervention will be administered. All patients with endoscopic remission will be monitored for the future development of major clinical events. Diagnostic performances of endoscopic remission for predicting major clinical events will be calculated. |
| IBD patients with histologic remission | – | Other: Recording of major clinical eventsNo intervention will be administered. All patients with histologic remission will be monitored for the future development of major clinical events. Diagnostic performances of histologic remission for predicting major clinical events will be calculated. |
| IBD patients with barrier healing | – | Other: Recording of major clinical eventsNo intervention will be administered. All patients with barrier healing will be monitored for the future development of major clinical events. Diagnostic performances of barrier healing for predicting major clinical events will be calculated. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with an established IBD diagnosis for at least 12 months duration presenting in clinical remission presenting at the Department of Gastroenterology of the University Hospital Erlangen will be prospectively included.
Key inclusion criteria (2 listed)
- patients with an established IBD diagnosis for at least 12 months duration
- IBD patients in clinical remission
Key exclusion criteria (5 listed)
- patients with poor bowel preparation
- patients with total colectomy,
- patients with concomitant beta blocker therapy,
- patients with known allergy to fluorescein
- patients with a planned change in IBD-related pharmacotherapy
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 |
|---|---|---|
| Recording of major clinical eventsDuring follow-up, major clinical events, defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded. | Other | IBD patients with barrier healing, IBD patients with endoscopic remission, IBD patients with histologic remission |
Primary outcome
Predictive value of endoscopic remission in ulcerative colitis
Time frame: 2 years
Endoscopic remission will be assessed using the Mayo Endoscopy Score in ulcerative colitis
Predictive value of endoscopic remission in Crohn's disease
Time frame: 2 years
Endoscopic remission will be assessed using the simplified endoscopic index of severity (SES-CD) in Crohn's disease
Predictive value of histologic remission in ulcerative colitis
Time frame: 2 years
Histologic remission will be assessed using the Robarts Histology Index and the Nancy Histology Index in ulcerative colitis
Predictive value of histologic remission in Crohn's disease
Time frame: 2 years
Histologic remission will be assessed using a modified Riley Score in Crohn's disease
Predictive value of barrier healing
Time frame: 2 years
Barrier healing will be assessed using the well-established Watson-Score as a semiquantitative grading system of the intestinal barrier function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Derived from this study: PubMed 37881628Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CI, Vitali F, Zundler S, Waldner MJ, Hartmann A, Neurath MF. Healing of the epithelial barrier in the ileum is superior to endoscopic and histologic remission for predicting major adverse outcomes in ulcerative colitis. Front Med (Lausanne). 2023 Oct 10;10:1221449. doi: 10.3389/fmed.2023.1221449. eCollection 2023.
- Derived from this study: PubMed 36279923Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.
- Individual participant dataSharing planned: No
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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.
Timo Rath, MD principal investigator
University Hospital Erlangen, Department of Medicine 1
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 Inflammatory Bowel Diseases, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 15 Dec 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timo Rath, MD (+49 913185-35000, timo.rath@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of endoscopic remission in ulcerative colitis (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05157750, which also lists 2 linked publications.
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 15 Dec 2021.