Inflammatory Bowel DiseasesIBDTrNCT03953794
Inflammatory Bowel Disease Tracker (IBD Tracker)
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Massachusetts General Hospital.
Trial summary
Inflammatory Bowel Diseases are incurable, life-long conditions that significantly impact a patient's quality of life. Crohn's Disease and ulcerative colitis are the most prevalent inflammatory bowel diseases in the United States; both are characterized by chronic, relapsing inflammation of the intestinal tract, which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Fitbit Charge 3
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Feb 2021
- How long will I take part?
- 12 Months
- 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: Adults with established inflammatory bowel disease who have had quiescent disease for at least 3 months but have experienced a flare within the last 24 months
Who may be able to join
- 18 years of age or older
- Able to provide written informed consent prior to screening and willing to comply with the requirements of the study protocol
- Have had a diagnosis of ulcerative colitis or Crohn's Disease confirmed by a clinician
- Have had quiescent disease for the past 3 months or longer as determined by clinician
- Have had most recent episode of disease within past 24 months as determined by clinician
- Have had stable IBD medication (other than antibiotics) regimen for the past 3 months or longer
- Able to speak and read English sufficiently
- Be able and comfortable using new technology: the app and the smartwatch for 12 months
Who cannot join
- 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
- Current use of glucocorticoid steroid, or nonsteroidal anti-inflammatory drugs (NSAIDs) within the last 3 months
- Evidence of untreated infection e.g. Clostridium difficile
- Confirmed diagnosis of extraintestinal manifestations (EIMs) of disease including those that occur concurrent with colitis (episcleritis, scleritis, uveitis, peripheral arthropathies of small and large joints, dermatologic conditions such as erythema nodosum and pyoderma gangrenosum), and those that occur independent of colitis (sacroilitis, ankylosing spondylitis, or primary sclerosing cholangitis)
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- Confirmed diagnosis of other serious disease unrelated to ulcerative colitis or Crohn's Disease
- Current smoker
- Unable to speak or read English
About this study
Inflammatory Bowel Diseases are incurable, life-long conditions that significantly impact a patient's quality of life. Crohn's Disease and ulcerative colitis are the most prevalent inflammatory bowel diseases in the United States; both are characterized by chronic, relapsing inflammation of the intestinal tract, which manifests as symptoms of diarrhea, fecal urgency, fecal incontinence, fever, fatigue, abdominal pain and cramping. These severely debilitating periods of illness or "flare" alternate with times of remission when patients have few or no symptoms, and feel healthy. Despite periodic respite, many patients with IBD experience severe stress and anxiety even when they are well, because of the likely occurrence of episodes of disease in their future. This is exacerbated by the unpredictable frequency and inconsistent duration of flares that may last as long as several weeks or months.
The goal for this study is to use non-invasive monitoring techniques to identify biomarkers that emerge, or change predictably, when a patient begins to relapse from remission to enter a period of disease - to find the earliest signs of an active flare. If the investigators identify a pattern of biomarkers that could alert a patient and their clinician to a flare as soon as it begins, it may be possible to intervene before symptoms present by changing medication and/or diet and lifestyle to lessen the severity of the disease flare. The biomarker fingerprint may also reveal new targets for therapeutics that could control IBD.
Read the detailed description
Inflammatory Bowel Disease (IBD) is a chronic, incurable, life-long condition that significantly negatively impacts a patient's quality of life, and increases their risk of developing colorectal cancer. The causes of IBD are currently unknown, but are thought to be a combination of factors related to an individual's genetics, environment and immune system. A common characteristic of ulcerative colitis and Crohn's Disease, the most prevalent forms of IBDs in the United States, are chronic, relapsing inflammation of the intestinal tract. When patients are in remission they are healthy with no or few symptoms, and can lead normal and productive lives. However, these periods of health alternate with periods of illness (flares) with an unpredictable frequency, during which patients suffer from an array of symptoms including diarrhea, fecal urgency, fecal incontinence, fever, fatigue, abdominal pain and cramping. Inflammation in the colon and rectum often causes ulcers that bleed resulting in bloody stools; as inflammation continues, ulcers can get larger, and even join together increasing the volume of blood lost, leading to anemia in some cases. During episodes of active disease, patients experience a reduced appetite and unintended weight loss. Flares do not have a consistent duration, and can last from weeks to months. Symptoms can range from mild to severe, and can change over time.
According to the Centers for Disease Control and Prevention, there are currently an estimated 1-1.3 million people with IBD in the United States, and most of these patients are diagnosed with the disease before age 30. The burden of living with these lifelong conditions is obviously severe, however the financial burden should also be considered. In 2008, the total annual financial burden for direct treatments costs for patients with IBD in the United States was estimated to be $6.3 billion. Costs includes expenses such as physician services, prescription and over-the-counter drugs, hospitalization, and other direct medical expenses. Indirect costs (including lost earnings or productivity, and lost leisure time) were estimated to amount to an additional $5.5 billion.
Although the study is not targeted at finding a cure for IBD, the goal is to vastly improve the patient's quality of life by identifying biomarkers that emerge, or change predictably in a period leading up to the very beginning of a flare.
The investigators will identify biomarkers that predict an episode of disease is imminent. The investigators will target biomarkers that can be tracked non-invasively, by monitoring changes in the stool microbiome, metabolites in stool and urine, as well as physiological and lifestyle changes by asking patients to wear a wearable device (the Fitbit Charge 3). The investigators will collect blood samples regularly (blood draws are minimally invasive) to monitor additional biomarkers. By intensively monitoring patients in this way for a period of time that encompasses health (remission) and disease (flare), as well as the transition period in between, the investigators hope to amass enough data to tease out such a biomarker, or fingerprint of biomarkers, that benchmark the earliest stages of a flare. The investigators will conduct this study in collaboration with researchers at the Center for Microbiome Informatics and Therapeutics at Massachusetts Institute of Technology.
The ability to non-invasively track biomarkers, to monitor a patient for such an early disease fingerprint, may give that patient the power to manage their lives and their disease with greater precision than they can today. In particular, if that early disease fingerprint appears at a time when the patient still feels well, it is possible they could intervene to block progression of the flare by changing medications, and/or making lifestyle changes thus minimizing the impact of the flare, and the symptoms they experience.
Furthermore, pinpointing the molecular changes that occur systemically, throughout the patients during this transition period, from health (remission) to disease (flare) will give researchers the knowledge and tools with which to begin to develop therapies that can block progression of the disease state, preventing the flare, and perhaps "reset" the body to a state of health. Therapies, like these would greatly relieve the burdens of disease and financial costs for this patient population.
- Being tested
- Fitbit Charge 3
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Charge 3Device
Smart watch monitoring activity and movement, heart rate, sleep, and more
| Study group | Role | What they receive |
|---|---|---|
| Patients with inflammatory bowel disease | Patients who have...
1. a diagnosis of ulcerative colitis or Crohn's disease as confirmed by a clinician
2. experienced a flare within the past 24 months as determined by a clinician
3. had quiescent disease for at least 3 months as determined by a clinician Receives: Device: Fitbit Charge 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Clinical Colitis Activity Index
Patient-reported measure for ulcerative colitis referring to disease symptoms occurring over the last week. The point value from each answer is added up for a total score.
- Over the past week, what is your average number of bowel movements during the day (not including night)? (0) 0-3 (1) 4-6 (2) 7-9 (3) >9
- Over the past week, what is your average number of bowel movements at night? (0) 0 (1) 1-3 (2) >3
- Over the past week, what has been your urgency of defecation? (0) No rush (1) Hurry (2) Immediately (3) Incontinence
- Over the past week, what has been the amount and frequency of blood in your stool? (0) None (1) Small traces (2) Occasionally obviously bloody (3) Usually obviously bloody
- General well being (0) Very well (1) Slightly below par (2) Poor (3) Very poor (4) Terrible
- During the past week, have you had any of the following? (1 pt/answer) (1) Pyoderma gangrenosum (1) Erythema nodosum (1) Uveitis (1) Arthritis (0) None
Measured: 1 week
Harvey-Bradshaw Index
Patient-reported measure for Crohn's disease referring to disease symptoms occurring over the last week. The point value from each answer is added up for a total score.
- General well being (0) Very well (1) Slightly below par (2) Poor (3) Very poor (4) Terrible
- In the past week, have you experienced any abdominal pain? (0) None (1) Mild (2) Moderate (3) Severe
- How many liquid stools do you pass per day? (1 point per liquid stool)
- Do you have an abdominal mass? (0) None (1) Dubious (2) Definite (3) Definite and tender
- During the past week, have you had any of the following? (1 point per answer) (1) Pyoderma gangrenosum (oozing ulcers, usually on the leg) (1) Erythema nodosum (red, swollen bumps, on the skin (1) Uveitis (red, painful eyes) (1) Aphthous ulcers (mouth ulcers) (1) Arthritis (joint pain) (1) Anal fissue (1) New fistula (1) Perianal abscess (0) None of the above
Measured: 1 week
Stress and Wellbeing
Patient-reported measure of current stress level measured on a scale of 1 (1 = no stress) to 5 (5 = highest stress possible)
Measured: Current moment in time
24-hour dietary recall survey
Patient-reported measure of diet over the last 24 hours. The survey can be found here: https://asa24.nci.nih.gov/demo/
Measured: 24 hours
Blood biomarkers - metabolite content
Metabolite content will be determined by monitoring patients via regular blood draws over the 12-month study period. By analyzing metabolite content in periods of health (remission), disease (flare), and the transition period in between, investigators hope to identify unique biomarkers that indicate the earliest stages of a flare. The investigators do not know each specific metabolite that will be measured. The objective of this outcome is to identify any and all possible biomarkers and metabolites that may be present in these samples.
Measured: 12 months
Blood biomarkers - cytokine profile
Cytokine profile will be determined by monitoring patients via regular blood draws over the 12-month study period. By analyzing cytokine profile in periods of health (remission), disease (flare), and the transition period in between, investigators hope to identify unique biomarkers that indicate the earliest stages of a flare. The investigators do not know each specific biomarker and cytokine that will be measured. The objective of this outcome is to identify any and all cytokines that may be present in these samples.
Measured: 12 months
Blood biomarkers - T-cell receptor sequence profile
T-cell receptor sequence profiles will be determined by monitoring patients via regular blood draws over the 12-month study period. By analyzing T-cell receptor sequence profiles in periods of health (remission), disease (flare), and the transition period in between, investigators hope to identify unique biomarkers that indicate the earliest stages of a flare.
Measured: 12 months
Stool biomarkers - microbial DNA content in microbiome
Patients will submit weekly stool samples for analysis and monitoring. The investigators will analyze the gut microbiome composition by characterizing the microbial DNA content and tracking changes throughout the 12-month study period. The investigators do not know each microbe that will be assessed. The objective of this outcome is to identify any and all microbes that may be present in these samples.
Measured: 12 months
Stool biomarkers - overall microbiome content
The investigators will analyze the bacterial, fungal, and viral constituents at enrollment and and track changes throughout the 12-month study period to identify biomarkers of importance. These will be assessed with stool wipe samples, glycerol-preserved stool, and fresh and ethanol-preserved stool samples. Stool samples will either collected by patients at home or collected in-clinic and flash frozen.
Measured: 12 months
Stool biomarkers - degree of intestinal inflammation via Fecal Calprotectin
The investigators will measure the degree of intestinal inflammation by quantifying Fecal Calprotectin (a biomarker) levels in patients' weekly stool samples and tracking changes throughout the 12-month study period. This will be measured using stool wipe samples and fresh stool samples.
Measured: 12 months
Urine biomarkers - metabolite content
The investigators will use urine samples collected throughout the study to analyze each subject's urine metabolite content and track changes throughout the 12-month study period in an attempt to identify biomarkers potentially indicative of a flare. The investigators do not know each specific metabolite that will be measured. The objective of this outcome is to identify any and all possible biomarkers and metabolites that may be present in these samples.
Measured: 12 months
Secondary outcomes (4)
Biospecimen association - microbiome timeseries and blood and stool metabolites
Investigators will measure any existing correlations between the microbiome timeseries and the identified blood and stool metabolites over the 12-month study period to determine if there are any associations between the two variables.
Measured: 12 months
Biospecimen association - microbiome composition and fecal calprotectin levels
Investigators will measure any existing correlations between the microbiome composition and fecal calprotectin levels identified in the primary outcomes over the 12-month study period to determine if there are any associations between the two variables.
Measured: 12 months
Biospecimen association - blood and stool metabolites and microbiome composition
Investigators will measure any existing correlations between the identified blood and stool metabolites and the microbiome composition over the 12-month study period to determine if there are any associations between the two variables.
Measured: 12 months
Biospecimen association - stool metabolites and blood metabolites
Investigators will measure any existing correlations between the identified blood metabolites and the identified stool metabolites and the microbiome composition over the 12-month study period to determine if there are any associations between the two variables.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study startOct 2019 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, University Medical Center Groningen
- Responsible party
- Principal investigator, Ashwin Ananthakrishnan, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953794
- Sponsor's protocol ID
- 2017P002778
- Acronym
- IBDTr
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2019
- Last updated
- 28 Apr 2020
- 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 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Bowel Disease Tracker (IBD Tracker)
- ClinicalTrials.gov ID
- NCT03953794
- Acronym / sponsor ID
- IBDTr / 2017P002778
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, University Medical Center Groningen
- Study start
- Oct 2019 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 17 May 2019 (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.
Inflammatory Bowel Diseases are incurable, life-long conditions that significantly impact a patient's quality of life. Crohn's Disease and ulcerative colitis are the most prevalent inflammatory bowel diseases in the United States; both are characterized by chronic, relapsing inflammation of the intestinal tract, which manifests as symptoms of diarrhea, fecal urgency, fecal incontinence, fever, fatigue, abdominal pain and cramping. These severely debilitating periods of illness or "flare" alternate with times of remission when patients have few or no symptoms, and feel healthy. Despite periodic respite, many patients with IBD experience severe stress and anxiety even when they are well, because of the likely occurrence of episodes of disease in their future. This is exacerbated by the unpredictable frequency and inconsistent duration of flares that may last as long as several weeks or months.
The goal for this study is to use non-invasive monitoring techniques to identify biomarkers that emerge, or change predictably, when a patient begins to relapse from remission to enter a period of disease - to find the earliest signs of an active flare. If the investigators identify a pattern of biomarkers that could alert a patient and their clinician to a flare as soon as it begins, it may be possible to intervene before symptoms present by changing medication and/or diet and lifestyle to lessen the severity of the disease flare. The biomarker fingerprint may also reveal new targets for therapeutics that could control IBD.
Detailed description
Inflammatory Bowel Disease (IBD) is a chronic, incurable, life-long condition that significantly negatively impacts a patient's quality of life, and increases their risk of developing colorectal cancer. The causes of IBD are currently unknown, but are thought to be a combination of factors related to an individual's genetics, environment and immune system. A common characteristic of ulcerative colitis and Crohn's Disease, the most prevalent forms of IBDs in the United States, are chronic, relapsing inflammation of the intestinal tract. When patients are in remission they are healthy with no or few symptoms, and can lead normal and productive lives. However, these periods of health alternate with periods of illness (flares) with an unpredictable frequency, during which patients suffer from an array of symptoms including diarrhea, fecal urgency, fecal incontinence, fever, fatigue, abdominal pain and cramping. Inflammation in the colon and rectum often causes ulcers that bleed resulting in bloody stools; as inflammation continues, ulcers can get larger, and even join together increasing the volume of blood lost, leading to anemia in some cases. During episodes of active disease, patients experience a reduced appetite and unintended weight loss. Flares do not have a consistent duration, and can last from weeks to months. Symptoms can range from mild to severe, and can change over time.
According to the Centers for Disease Control and Prevention, there are currently an estimated 1-1.3 million people with IBD in the United States, and most of these patients are diagnosed with the disease before age 30. The burden of living with these lifelong conditions is obviously severe, however the financial burden should also be considered. In 2008, the total annual financial burden for direct treatments costs for patients with IBD in the United States was estimated to be $6.3 billion. Costs includes expenses such as physician services, prescription and over-the-counter drugs, hospitalization, and other direct medical expenses. Indirect costs (including lost earnings or productivity, and lost leisure time) were estimated to amount to an additional $5.5 billion.
Although the study is not targeted at finding a cure for IBD, the goal is to vastly improve the patient's quality of life by identifying biomarkers that emerge, or change predictably in a period leading up to the very beginning of a flare.
The investigators will identify biomarkers that predict an episode of disease is imminent. The investigators will target biomarkers that can be tracked non-invasively, by monitoring changes in the stool microbiome, metabolites in stool and urine, as well as physiological and lifestyle changes by asking patients to wear a wearable device (the Fitbit Charge 3). The investigators will collect blood samples regularly (blood draws are minimally invasive) to monitor additional biomarkers. By intensively monitoring patients in this way for a period of time that encompasses health (remission) and disease (flare), as well as the transition period in between, the investigators hope to amass enough data to tease out such a biomarker, or fingerprint of biomarkers, that benchmark the earliest stages of a flare. The investigators will conduct this study in collaboration with researchers at the Center for Microbiome Informatics and Therapeutics at Massachusetts Institute of Technology.
The ability to non-invasively track biomarkers, to monitor a patient for such an early disease fingerprint, may give that patient the power to manage their lives and their disease with greater precision than they can today. In particular, if that early disease fingerprint appears at a time when the patient still feels well, it is possible they could intervene to block progression of the flare by changing medications, and/or making lifestyle changes thus minimizing the impact of the flare, and the symptoms they experience.
Furthermore, pinpointing the molecular changes that occur systemically, throughout the patients during this transition period, from health (remission) to disease (flare) will give researchers the knowledge and tools with which to begin to develop therapies that can block progression of the disease state, preventing the flare, and perhaps "reset" the body to a state of health. Therapies, like these would greatly relieve the burdens of disease and financial costs for this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with inflammatory bowel disease | – | Device: Fitbit Charge 3Patients who have... 1. a diagnosis of ulcerative colitis or Crohn's disease as confirmed by a clinician 2. experienced a flare within the past 24 months as determined by a clinician 3. had quiescent disease for at least 3 months as determined by a clinician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with established inflammatory bowel disease who have had quiescent disease for at least 3 months but have experienced a flare within the last 24 months
Key inclusion criteria (8 listed)
- 18 years of age or older
- Able to provide written informed consent prior to screening and willing to comply with the requirements of the study protocol
- Have had a diagnosis of ulcerative colitis or Crohn's Disease confirmed by a clinician
- Have had quiescent disease for the past 3 months or longer as determined by clinician
- Have had most recent episode of disease within past 24 months as determined by clinician
Key exclusion criteria (9 listed)
- 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
- Current use of glucocorticoid steroid, or nonsteroidal anti-inflammatory drugs (NSAIDs) within the last 3 months
- Evidence of untreated infection e.g. Clostridium difficile
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 |
|---|---|---|
| Fitbit Charge 3Smart watch monitoring activity and movement, heart rate, sleep, and more | Device | Patients with inflammatory bowel disease |
Primary outcome
Simple Clinical Colitis Activity Index
Time frame: 1 week
Patient-reported measure for ulcerative colitis referring to disease symptoms occurring over the last week. The point value from each answer is added up for a total score. 1. Over the past week, what is your average number of bowel movements during the day (not including night)? (0) 0-3 (1) 4-6 (2) 7-9 (3) >9 2. Over the past week, what is your average number of bowel movements at night? (0) 0 (1) 1-3 (2) >3 3. Over the past week, what has been your urgency of defecation? (0) No rush (1) Hurry (2) Immediately (3) Incontinence 4. Over the past week, what has been the amount and frequency of blood in your stool? (0) None (1) Small traces (2) Occasionally obviously bloody (3) Usually obviously bloody 5. General well being (0) Very well (1) Slightly below par (2) Poor (3) Very poor (4) Terrible 6. During the past week, have you had any of the following? (1 pt/answer) (1) Pyoderma gangrenosum (1) Erythema nodosum (1) Uveitis (1) Arthritis (0) None
Harvey-Bradshaw Index
Time frame: 1 week
Patient-reported measure for Crohn's disease referring to disease symptoms occurring over the last week. The point value from each answer is added up for a total score. 1. General well being (0) Very well (1) Slightly below par (2) Poor (3) Very poor (4) Terrible 2. In the past week, have you experienced any abdominal pain? (0) None (1) Mild (2) Moderate (3) Severe 3. How many liquid stools do you pass per day? (1 point per liquid stool) 4. Do you have an abdominal mass? (0) None (1) Dubious (2) Definite (3) Definite and tender 5. During the past week, have you had any of the following? (1 point per answer) (1) Pyoderma gangrenosum (oozing ulcers, usually on the leg) (1) Erythema nodosum (red, swollen bumps, on the skin (1) Uveitis (red, painful eyes) (1) Aphthous ulcers (mouth ulcers) (1) Arthritis (joint pain) (1) Anal fissue (1) New fistula (1) Perianal abscess (0) None of the above
Stress and Wellbeing
Time frame: Current moment in time
Patient-reported measure of current stress level measured on a scale of 1 (1 = no stress) to 5 (5 = highest stress possible)
24-hour dietary recall survey
Time frame: 24 hours
Patient-reported measure of diet over the last 24 hours. The survey can be found here: https://asa24.nci.nih.gov/demo/
Blood biomarkers - metabolite content
Time frame: 12 months
Metabolite content will be determined by monitoring patients via regular blood draws over the 12-month study period. By analyzing metabolite content in periods of health (remission), disease (flare), and the transition period in between, investigators hope to identify unique biomarkers that indicate the earliest stages of a flare. The investigators do not know each specific metabolite that will be measured. The objective of this outcome is to identify any and all possible biomarkers and metabolites that may be present in these samples.
Blood biomarkers - cytokine profile
Time frame: 12 months
Cytokine profile will be determined by monitoring patients via regular blood draws over the 12-month study period. By analyzing cytokine profile in periods of health (remission), disease (flare), and the transition period in between, investigators hope to identify unique biomarkers that indicate the earliest stages of a flare. The investigators do not know each specific biomarker and cytokine that will be measured. The objective of this outcome is to identify any and all cytokines that may be present in these samples.
Blood biomarkers - T-cell receptor sequence profile
Time frame: 12 months
T-cell receptor sequence profiles will be determined by monitoring patients via regular blood draws over the 12-month study period. By analyzing T-cell receptor sequence profiles in periods of health (remission), disease (flare), and the transition period in between, investigators hope to identify unique biomarkers that indicate the earliest stages of a flare.
Stool biomarkers - microbial DNA content in microbiome
Time frame: 12 months
Patients will submit weekly stool samples for analysis and monitoring. The investigators will analyze the gut microbiome composition by characterizing the microbial DNA content and tracking changes throughout the 12-month study period. The investigators do not know each microbe that will be assessed. The objective of this outcome is to identify any and all microbes that may be present in these samples.
Stool biomarkers - overall microbiome content
Time frame: 12 months
The investigators will analyze the bacterial, fungal, and viral constituents at enrollment and and track changes throughout the 12-month study period to identify biomarkers of importance. These will be assessed with stool wipe samples, glycerol-preserved stool, and fresh and ethanol-preserved stool samples. Stool samples will either collected by patients at home or collected in-clinic and flash frozen.
Stool biomarkers - degree of intestinal inflammation via Fecal Calprotectin
Time frame: 12 months
The investigators will measure the degree of intestinal inflammation by quantifying Fecal Calprotectin (a biomarker) levels in patients' weekly stool samples and tracking changes throughout the 12-month study period. This will be measured using stool wipe samples and fresh stool samples.
Urine biomarkers - metabolite content
Time frame: 12 months
The investigators will use urine samples collected throughout the study to analyze each subject's urine metabolite content and track changes throughout the 12-month study period in an attempt to identify biomarkers potentially indicative of a flare. The investigators do not know each specific metabolite that will be measured. The objective of this outcome is to identify any and all possible biomarkers and metabolites that may be present in these samples.
4 secondary outcomes
Biospecimen association - microbiome timeseries and blood and stool metabolites
Time frame: 12 months
Biospecimen association - microbiome composition and fecal calprotectin levels
Time frame: 12 months
Biospecimen association - blood and stool metabolites and microbiome composition
Time frame: 12 months
Biospecimen association - stool metabolites and blood metabolites
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Massachusetts General Hospital.
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 8 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Simple Clinical Colitis Activity Index (time frame: 1 week). The study lists 11 primary outcomes in all. 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 Apr 2020.