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.
Condition or disease | Intervention/treatment |
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Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease | Device: Fitbit Charge 3 |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | Inflammatory Bowel Disease Tracker (IBD Tracker) |
Estimated Study Start Date : | October 2019 |
Estimated Primary Completion Date : | February 2021 |
Estimated Study Completion Date : | February 2021 |
Group/Cohort | Intervention/treatment |
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Patients with inflammatory bowel disease
Patients who have...
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Device: Fitbit Charge 3
Smart watch monitoring activity and movement, heart rate, sleep, and more
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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.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
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First Submitted Date | April 10, 2019 | ||||
First Posted Date | May 17, 2019 | ||||
Last Update Posted Date | April 28, 2020 | ||||
Estimated Study Start Date | October 2019 | ||||
Estimated Primary Completion Date | February 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Inflammatory Bowel Disease Tracker (IBD Tracker) | ||||
Official Title | Inflammatory Bowel Disease Tracker (IBD Tracker) | ||||
Brief 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 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. |
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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. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 12 Months | ||||
Biospecimen | Retention: Samples With DNA Description:
Optional blood, stool, and urine samples will be requested at various time points throughout the 12-month follow-up period. Optional biopsy samples can be collected at a standard-of-care endoscopic procedure.
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Sampling Method | Non-Probability Sample | ||||
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 | ||||
Condition |
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Intervention | Device: Fitbit Charge 3
Smart watch monitoring activity and movement, heart rate, sleep, and more
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Study Groups/Cohorts | Patients with inflammatory bowel disease
Patients who have...
Intervention: Device: Fitbit Charge 3
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Withdrawn | ||||
Actual Enrollment |
0 | ||||
Original Estimated Enrollment |
100 | ||||
Estimated Study Completion Date | February 2021 | ||||
Estimated Primary Completion Date | February 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03953794 | ||||
Other Study ID Numbers | 2017P002778 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Ashwin Ananthakrishnan, Massachusetts General Hospital | ||||
Study Sponsor | Massachusetts General Hospital | ||||
Collaborators |
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Investigators | Not Provided | ||||
PRS Account | Massachusetts General Hospital | ||||
Verification Date | April 2020 |