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New treatment option for Inflammatory Bowel Disease
Official title A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
ClinicalTrials.gov ID: NCT05579392
What this study is testing
- What it's testing
- Crohn's Disease (CD) and Ulcerative Colitis (UC), collectively known as inflammatory bowel disease (IBD), are two of the most significant chronic conditions of the gastrointestinal tract (GIT) and affects over 1.5 million individuals in the U.S. Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potentially modifiable risk factor.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
- 18 years or older
- Fecal Calprotectin \> 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50
- Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks
You likely can't join if
- Active IBD (Harvey Bradshaw Index \> 5 or Modified Harvey Bradshaw Index \>5)
- Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression)
- Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43)
- Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))
- Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blockers...
- People who have worked night shifts or crossed more than 2 time zones in the previous month
See the full eligibility criteria
- Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
- 18 years or older
- Fecal Calprotectin \> 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50
- Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks
- Active IBD (Harvey Bradshaw Index \> 5 or Modified Harvey Bradshaw Index \>5)
- Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression)
- Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43)
- Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))
- Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blockers, psychotropic medications, hypnotics and exogenous melatonin products during 4...
- People who have worked night shifts or crossed more than 2 time zones in the previous month
- Any major organ disease - renal impairment (creatinine\>1.2 mg/dL), diabetes (Hgb-A1c \> 6.5%); liver disease (LFTs \> 1.5x normal), or significant cardiac failure (NY classification stage III/IV)
- Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening
- Inability to sign an informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.