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A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Eligible participants will complete questionnaires assessing their dietary habits, fatigue, sleep habits, quality of life, and severity of their underlying disease."
  • "Once the subjects demonstrate both subjective and objective evidence of CM, during their follow-up visit they will be randomly assigned to wear either the Re-Timer device to receive BLT or the placebo Re-Timer device (non BLT) for 4 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests morning bright light therapy in adults with Crohn’s disease or ulcerative colitis, which cause swelling in the gut. Researchers want to see if the therapy makes the gut less leaky, lowers inflammation, changes gut bacteria, and improves quality of life.

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. We, therefore, hypothesize that intervening with morning bright light therapy (BLT) in IBD patients with CM will decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Crohn’s disease or ulcerative colitis confirmed by a biopsy (a small tissue sample).
  • At least one of these: a stool calprotectin level above 50, a blood CRP level above normal, or a PROMISE fatigue score of 50 or higher. Calprotectin and CRP measure inflammation.
  • On the same dose of a biologic, immunomodulator, or 5-ASA medicine for at least 12 weeks. These medicines treat bowel inflammation.

Who can't join

  • Active bowel disease, with a Harvey Bradshaw Index or modified version score above 5.
  • Major depression, with a Beck Depression score of 21 or higher, or any report of intent to attempt suicide.
  • High risk for sleep apnea (breathing pauses during sleep) in at least two areas of the Berlin survey, or restless legs syndrome with an IRLS score of 15 or higher.
  • Regular use in the past 4 weeks of medicines that affect gut leakiness or melatonin, a sleep-related hormone. These include metoclopramide, NSAID pain medicines, beta blockers, mental health medicines, sleep medicines, and melatonin products.
  • Night-shift work or travel across more than two time zones in the past month.
  • Major organ disease: kidney problems with creatinine above 1.2 mg/dL; diabetes with A1c above 6.5%; liver tests above 1.5 times normal; or serious heart failure in class III or IV.
  • Narrow-angle glaucoma (an eye pressure problem), disorders of the retina (the light-sensing layer of the eye), or signs of these during screening.
  • Unable to sign the form agreeing to take part in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Biopsy proven diagnosis of Crohn's or Ulcerative Colitis 2. 18 years or older 3. Fecal Calprotectin \> 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50 4. Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks Exclusion Criteria: 1. Active IBD (Harvey Bradshaw Index \> 5 or Modified Harvey Bradshaw Index \>5) 2. Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression) 3. Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43) 4. Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44)) 5. 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 weeks prior to the study 6. People who have worked night shifts or crossed more than 2 time zones in the previous month 7. 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) 8. Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening 9. Inability to sign an informed consent

Study sites (2)

IL

SC