Inflammatory Bowel Disease Tracker (IBD Tracker)

NCT03953794 | Withdrawn

• 1 other identifier: 2017P002778
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (11)

• 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. 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

  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. 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

  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)

  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/

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  12 months

Secondary Outcomes (4)

• Biospecimen association - microbiome timeseries and blood and stool metabolites

  12 months

• Biospecimen association - microbiome composition and fecal calprotectin levels

  12 months

• Biospecimen association - blood and stool metabolites and microbiome composition

  12 months

• Biospecimen association - stool metabolites and blood metabolites

  12 months

Study Arms (1)

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

Device: Fitbit Charge 3

Interventions

Fitbit Charge 3 DEVICE

Smart watch monitoring activity and movement, heart rate, sleep, and more

Patients with inflammatory bowel disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)
• Confirmed diagnosis of other serious disease unrelated to ulcerative colitis or Crohn's Disease
• Current smoker
• Unable to speak or read English

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Institute of Technology: collaborator
• University Medical Center Groningen: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: May 17, 2019
• Study Start: October 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: April 28, 2020

Record last verified: 2020-04