Ulcerative ColitisMAIDNCT01705522
Multimodal Approach in IBD Patients
An observational study of Ulcerative Colitis and Crohn's Disease, run by Clinical Hospital Colentina at 1 site in Romania.
Trial summary
The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease, Nonalcoholic Fatty Liver Disease (NAFLD)
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- Oct 2012to Oct 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with IBD over 18 years of age, currently in clinical remission
Who may be able to join
- ulcerative colitis or Crohn's disease
- age over 18
- clinical remission
- signed informed consent
Who cannot join
- pregnant women
- refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Colentina Clinical Hospital
Bucharest, 020125
Andreea Bengus, MD, 0040744497626, andreeabengus@yahoo.com
Theodor A Voiosu, MD
About this study
The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.
Read the detailed description
Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis in order to assess relapse risk factors.
Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.
Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal calprotectin).
Data about current and past medication for IBD will also be gathered.
- Conditions
- Ulcerative Colitis, Crohn's Disease, Nonalcoholic Fatty Liver Disease (NAFLD), Vitamin D Deficiency
- Keywords
- IBD, ulcerative colitis, Crohn's disease, NAFLD, biomarkers, vitamin D
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Non-alcoholic Fatty Liver Disease, Vitamin D Deficiency
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 |
|---|---|---|
| IBD patients | patients with ulcerative colitis or crohn's disease, in remission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical relapse
clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI
Measured: 1 year
Prevalence of NAFLD
to assess the prevalence of nonalcoholic liver disease in IBD patients
Measured: 1 year
prevalence of vitamin D deficiency
to assess vitamin D deficiency and osteopenia among IBD patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (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 Ulcerative ColitisStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
- Investigators
- Theodor Voiosu, Md, Principal investigator, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705522
- Sponsor's protocol ID
- COL-GASTRO-3
- Acronym
- MAID
- Status last verified
- Jan 2019
- First submitted
- 10 Oct 2012
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Dionne S, Hiscott J, D'Agata I, Duhaime A, Seidman EG. Quantitative PCR analysis of TNF-alpha and IL-1 beta mRNA levels in pediatric IBD mucosal biopsies. Dig Dis Sci. 1997 Jul;42(7):1557-66. doi: 10.1023/a:1018895500721.
PubMed 9246063Voiosu T, Bengus A, Dinu R, Voiosu AM, Balanescu P, Baicus C, Diculescu M, Voiosu R, Mateescu B. Rapid fecal calprotectin level assessment and the SIBDQ score can accurately detect active mucosal inflammation in IBD patients in clinical remission: a prospective study. J Gastrointestin Liver Dis. 2014 Sep;23(3):273-8. doi: 10.15403/jgld.2014.1121.233.thv.
PubMed 25267955
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Approach in IBD Patients
- ClinicalTrials.gov ID
- NCT01705522
- Acronym / sponsor ID
- MAID / COL-GASTRO-3
- Conditions
- Ulcerative Colitis, Crohn's Disease, Nonalcoholic Fatty Liver Disease (NAFLD), Vitamin D Deficiency
- Keywords
- IBD, ulcerative colitis, Crohn's disease, NAFLD, biomarkers, vitamin D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 12 Oct 2012 (estimated)
- 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 investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.
Detailed description
Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis in order to assess relapse risk factors.
Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.
Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal calprotectin).
Data about current and past medication for IBD will also be gathered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | –patients with ulcerative colitis or crohn's disease, in remission |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with IBD over 18 years of age, currently in clinical remission
Key inclusion criteria (4 listed)
- ulcerative colitis or Crohn's disease
- age over 18
- clinical remission
- signed informed consent
Key exclusion criteria (2 listed)
- pregnant women
- refusal to sign informed consent
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
Clinical relapse
Time frame: 1 year
clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI
Prevalence of NAFLD
Time frame: 1 year
to assess the prevalence of nonalcoholic liver disease in IBD patients
prevalence of vitamin D deficiency
Time frame: 1 year
to assess vitamin D deficiency and osteopenia among IBD patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Background: PubMed 9246063Dionne S, Hiscott J, D'Agata I, Duhaime A, Seidman EG. Quantitative PCR analysis of TNF-alpha and IL-1 beta mRNA levels in pediatric IBD mucosal biopsies. Dig Dis Sci. 1997 Jul;42(7):1557-66. doi: 10.1023/a:1018895500721.
- Derived from this study: PubMed 25267955Voiosu T, Bengus A, Dinu R, Voiosu AM, Balanescu P, Baicus C, Diculescu M, Voiosu R, Mateescu B. Rapid fecal calprotectin level assessment and the SIBDQ score can accurately detect active mucosal inflammation in IBD patients in clinical remission: a prospective study. J Gastrointestin Liver Dis. 2014 Sep;23(3):273-8. doi: 10.15403/jgld.2014.1121.233.thv.
Related trials for Ulcerative Colitis
Not yet recruitingObservational study
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), Crohn Disease
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
Not yet recruiting
Online Pain Education for Crohn's Disease and Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis (UC)
RecruitingObservational study
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Inflammatory Bowel Disease, Ulcerative Colitis
RecruitingPhase 2
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Colitis, Ulcerative
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.
Theodor Voiosu, Md principal investigator
Clinical Hospital Colentina
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 Ulcerative Colitis and Crohn's Disease, run by Clinical Hospital Colentina at 1 site in Romania.
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 2 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 31 Jan 2019. 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 Romania. 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 Theodor A Voiosu, MD (0040726732764, theodor.voiosu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical relapse (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT01705522, 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 31 Jan 2019.