The primary objective of this study is to identify biomarker fingerprints in patients with ulcerative colitis (UC) and Crohn*s disease (CD, that can indicate that an exacerbation has begun, although the patient still feels well. Ultimately, the…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in the gut microbiome, metabolome (in stool, in blood, and in urine),
and physiological biomarkers in correlation with patients* health or disease
state over the 12-month study period. At the end of the 12-month study period,
in all patients, we will have profiled numerous biomarkers, as well as tracked
their general well-being and disease activity using the clinical disease
activity scores (the Simple Clinical Colitis Activity Index for ulcerative
colitis, or the Harvey Bradshaw Index for Crohn*s Disease).
Secondary outcome
NA
Background summary
Inflammatory Bowel Diseases (IBD) are chronic, incurable, life-long conditions
characterized by disease episodes of relapsing inflammation of the intestinal
tract. In the United States and Europe, two forms of IBD are most prevalent,
ulcerative colitis and Crohn*s Disease. For both conditions, patients move
between active and inactive disease with an unpredictable frequency. During
periods of active disease (exacerbations), they suffer an array of symptoms
including diarrhoea, faecal urgency, faecal incontinence, fever, fatigue,
abdominal pain and cramping, that significantly negatively impact their quality
of life and make it difficult for them to adhere to regular daily routines. The
unpredictable nature of the disease course of IBD, the debilitating symptoms,
and the necessity of using immunosuppressant medication result in a high burden
of stress and an impaired quality of life for patients.
Study objective
The primary objective of this study is to identify biomarker fingerprints in
patients with ulcerative colitis (UC) and Crohn*s disease (CD, that can
indicate that an exacerbation has begun, although the patient still feels well.
Ultimately, the appearance of this biomarker fingerprint could proactively
trigger clinicians to change medications, or patients to change behaviours,
perhaps avoiding or lessening the severity of the exacerbation.
Secondary objectives of our study are to better understand disease progression
by characterising fluctuations in biomarkers from the microbiome, the
metabolome (stool, blood and urine), and the physiological parameters that
occur in individuals with ulcerative colitis and Crohn*s disease throughout a
12-month period, independent of whether they relapse or not. We will also
determine how the biomarkers from the microbiome, the metabolome, and
physiological parameters change in response to lifestyle and behavioral
stimuli.
Study design
This is a prospective, observational study that will enroll a total of 100
patients at 2 sites: a cohort of 50 patients at Universitair Medisch Centrum
Groningen (UMCG), The Netherlands, and another cohort of 50 patients at
Massachusetts General Hospital (MGH), Boston, USA. At each site, we will enroll
25 eligible patients with ulcerative colitis, and 25 eligible patients with
Crohn*s disease.
Study burden and risks
NA
Cambridge MA 02139 00
Boston 00000
US
Cambridge MA 02139 00
Boston 00000
US
Listed location countries
Age
Inclusion criteria
• 18 years of age or older
• Be able to provide written informed consent prior to screening and to comply with the requirements of the study protocol
• Be able to read and write Dutch sufficiently
• Be able and comfortable to use new technology: the app and the smartwatch for 12 months
• Live / work in proximity of the UMCG to permit sample collection by UMCG clinical team
• Have had diagnosis of ulcerative colitis or Crohn*s Disease confirmed by a clinician for a disease duration of more than 2 years
• Have had quiescent ulcerative colitis or Crohn*s disease for the past 3 months or longer
• Have had most recent episode of active disease within past 24 months
• Have had a stable IBD medication regimen for at least 3 months
Exclusion criteria
• If female, is pregnant or is breast feeding, or intends to become pregnant within the 12- month study period
• Unable to provide informed consent or unwilling to participate
• Use of oral or intravenous antibiotics within 4 weeks prior to screening
• Evidence of untreated infection e.g. Clostridium diffiicile
• Confirmed diagnosis of other serious disease unrelated to ulcerative colitis or Crohn*s disease
• Current alcohol or drug abuse
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62559.042.18 |