About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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))
Trial design
Crossover
Treatments tested in this trial
Bright Light Therapy
DeviceDevice: Bright Light Therapy Retimer
Placebo Retimer Device
DeviceDevice: Placebo Retimer Device with no bright light therapy
Treatment groups
Trial outcomes
Primary outcomes
Changes in intestinal permeability (% excretion of urinary sucralose)
Participants will ingest a sugar cocktail at Visits 2-5 and complete a urine collection. Measurement of urinary sugars is done using gas chromatography is used to calculate intestinal permeability.
Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA
At all study visits, stool samples will be collected and analyzed using shotgun metagene sequencing and total microbial community DNA will be isolated and processed for microbiome analysis.
Secondary outcomes
Change in systemic markers of barrier disruption and inflammation
Inflammatory cytokines (IL-6, TNF-α, and IL-8) are the markers of disruption. IL-6, IL-8, and TNF-α will be measured in the plasma.
Change in systemic markers of inflammation
markers of endotoxemia (LPS, LBP, and sCD14) will be used to assess inflammation. Lipopolysaccharide binding protein(LBP) and sCD14 will be measured in serum by high sensitivity ELISA. Lipopolysaccharide (LPS) will be measured in serum using a LAL assay which is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin.
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