Inflammatory Bowel DiseaseNCT02526251
Does the Microbiome in IBD Change Alongside Special Treatment Scenarios?
An observational study of Inflammatory Bowel Disease, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The purpose of this cohort study is to map, during one year in an e-health setting, patients having Inflammatory Bowel Disease (IBD) with mild to moderate activity in relation to dysbiosis (gut bacteria) and inflammation burden measured by disease activity questionnaires (HBI and SCCAI) and Fecal Calprotectin (FC) on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- observational
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Sep 2017
- 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: IBD patients in remission or mild to moderate active
Who may be able to join
- IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16)
- IBD patients who can read, speak and understand Danish
- IBD patients that can take advantage of the Internet and wireless network 18 years or older
Who cannot join
- IBD patients with severe disease activity ( HB > 16 SCCAI ≥ 5 )
- IBD patients with social, medical or psychological issues of a more complex character
- IBD patients with complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
- IBD patients who cannot attend due to language barrier or cognitive disorder.
- Age less than 18 years.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
North Zealand university hospital, Gastro unit
Frederikssund, Capital Region, 3600
About this study
The purpose of this cohort study is to map, during one year in an e-health setting, patients having Inflammatory Bowel Disease (IBD) with mild to moderate activity in relation to dysbiosis (gut bacteria) and inflammation burden measured by disease activity questionnaires (HBI and SCCAI) and Fecal Calprotectin (FC) on any smart phone. And Secondarily how dysbiosis defined by a dysbiosis index (DI) ranging from 1-5 is related to changes in disease activity and FC under different treatments scenarios. Is a certain DI or specific bacteria probes related to increase or reduced relapse rate. Moreover change in above mentioned parameters/indices will also be correlated to QoL and a fatigue score.
Read the detailed description
Among 2.500 IBD patients the investigators will consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruit in total 120 in the study.
At the out-patient consultation IBD patients will be informed about the project and the IBD eHealth nurse ensures that no exclusion criteria met by the patient.
Inclusion criteria: IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16) IBD patients who can read, speak and understand Danish IBD patients that can take advantage of the Internet and wireless network 18years or older.
Exclusion criteria: IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 ) IBD patients with social, medical or psychological issues of a more complex character IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact. IBD patients who cannot attend due to language barrier or cognitive disorder and IBD patients less than 18 years old.
When the patient has agreed to participate in this cohort study, they will measure their fecal calprotectin (FC) on any smart phone, rate their Disease activity (SCCAI or HBI) and send in a fecal sample for dysbiosis analysis/microbiome analysis. The Patients will do this every 3 month or on demand in an ehealth setting (see elaboration below).
Patients log in at www.noh.constant-care.dk throughout the project period of 12 months. When the patient log in to the telemedicine platform following scoring must be filled out:
- Send in a fecal sample for microbiome analysis/ Dysbiosis index (DI)
- Disease activity, respectively SCCAI or HBI.
- Quality of life assessment, s - IBDQ
- FACIT (Fatigue score)
- MARS ( Medical Adherence Rating Scale)
- FC, fecal calprotectin mg / kg feces) with SMART phone, rapid home test. If the patients prefer to send the feces test, it will be tested in the Gastro unit lab. at the hospital with SMART phone.
The results of the scoring systems will appear to the health professionals and patients in a traffic light manner turning into red, yellow and green.
If the patient experiences a recurrence of the disease, it moves from green to either yellow or red area in the traffic graph, and patient will further be instructed to contact Gastro medical clinic project nurse for an early consultation and decision on further treatment initiative. This will also be indicated at the patient's website. If alarm symptoms occurs patients are instructed to contact the project nurse. Thus patients are treated in accordance to national and international guideline.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- observational
- Keywords
- IBD, Fecal calprotectin, Microbiome, Dysbiosis, Disease activity, telemedicine
- Medical subject headings
- Inflammatory Bowel Diseases, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome
Platform signal based on PCR technique of variable regions of 16S rRNA of 54 bacterial probes identifying specific gut bacteria on genus and species level. These platform signals goes through an algorithm to generate a Dysbiosis index (DI) ranging from 1-5. GA Analysis has developed this algorithm.
Measured: one year
Secondary outcomes (1)
Total inflammation burden (TIBS)
TIBS is defined as: Fecal Calprotectin plus Disease Activity (Simple Clical Colitis Activity Index or Harvey-Bradshaw Index). Is TIBS associated with a certain Dysbiosis index (DI).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pia Munkholm, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526251
- Sponsor's protocol ID
- 49341
- Status last verified
- Sep 2017
- First submitted
- 4 Aug 2015
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Microbiome in IBD Change Alongside Special Treatment Scenarios?
- ClinicalTrials.gov ID
- NCT02526251
- Acronym / sponsor ID
- 49341
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD, Fecal calprotectin, Microbiome, Dysbiosis, Disease activity, telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Aug 2015 (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 purpose of this cohort study is to map, during one year in an e-health setting, patients having Inflammatory Bowel Disease (IBD) with mild to moderate activity in relation to dysbiosis (gut bacteria) and inflammation burden measured by disease activity questionnaires (HBI and SCCAI) and Fecal Calprotectin (FC) on any smart phone. And Secondarily how dysbiosis defined by a dysbiosis index (DI) ranging from 1-5 is related to changes in disease activity and FC under different treatments scenarios. Is a certain DI or specific bacteria probes related to increase or reduced relapse rate. Moreover change in above mentioned parameters/indices will also be correlated to QoL and a fatigue score.
Detailed description
Among 2.500 IBD patients the investigators will consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruit in total 120 in the study.
At the out-patient consultation IBD patients will be informed about the project and the IBD eHealth nurse ensures that no exclusion criteria met by the patient.
Inclusion criteria: IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16) IBD patients who can read, speak and understand Danish IBD patients that can take advantage of the Internet and wireless network 18years or older.
Exclusion criteria: IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 ) IBD patients with social, medical or psychological issues of a more complex character IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact. IBD patients who cannot attend due to language barrier or cognitive disorder and IBD patients less than 18 years old.
When the patient has agreed to participate in this cohort study, they will measure their fecal calprotectin (FC) on any smart phone, rate their Disease activity (SCCAI or HBI) and send in a fecal sample for dysbiosis analysis/microbiome analysis. The Patients will do this every 3 month or on demand in an ehealth setting (see elaboration below).
Patients log in at www.noh.constant-care.dk throughout the project period of 12 months. When the patient log in to the telemedicine platform following scoring must be filled out:
- Send in a fecal sample for microbiome analysis/ Dysbiosis index (DI)
- Disease activity, respectively SCCAI or HBI.
- Quality of life assessment, s - IBDQ
- FACIT (Fatigue score)
- MARS ( Medical Adherence Rating Scale)
- FC, fecal calprotectin mg / kg feces) with SMART phone, rapid home test. If the patients prefer to send the feces test, it will be tested in the Gastro unit lab. at the hospital with SMART phone.
The results of the scoring systems will appear to the health professionals and patients in a traffic light manner turning into red, yellow and green.
If the patient experiences a recurrence of the disease, it moves from green to either yellow or red area in the traffic graph, and patient will further be instructed to contact Gastro medical clinic project nurse for an early consultation and decision on further treatment initiative. This will also be indicated at the patient's website. If alarm symptoms occurs patients are instructed to contact the project nurse. Thus patients are treated in accordance to national and international guideline.
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
- IBD patients in remission or mild to moderate active
Key inclusion criteria (3 listed)
- IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16)
- IBD patients who can read, speak and understand Danish
- IBD patients that can take advantage of the Internet and wireless network 18 years or older
Key exclusion criteria (5 listed)
- IBD patients with severe disease activity ( HB > 16 SCCAI ≥ 5 )
- IBD patients with social, medical or psychological issues of a more complex character
- IBD patients with complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
- IBD patients who cannot attend due to language barrier or cognitive disorder.
- Age less than 18 years.
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 |
|---|---|---|
| observationalNo intervention | Other | – |
Primary outcome
Microbiome
Time frame: one year
Platform signal based on PCR technique of variable regions of 16S rRNA of 54 bacterial probes identifying specific gut bacteria on genus and species level. These platform signals goes through an algorithm to generate a Dysbiosis index (DI) ranging from 1-5. GA Analysis has developed this algorithm.
1 secondary outcome
Total inflammation burden (TIBS)
Time frame: one year
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 28 Sep 2017.
- 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.
Pia Munkholm, MD principal investigator
Professor
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 Disease, run by Nordsjaellands Hospital at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 28 Sep 2017. 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 Denmark. 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?
Microbiome (time frame: one year). 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 28 Sep 2017.