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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Bright Light Therapy

    Device

    Device: Bright Light Therapy Retimer

  • Placebo Retimer Device

    Device

    Device: Placebo Retimer Device with no bright light therapy

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Bright Light Therapy via ReTimer glasses, Then PlaceboExperimental treatment 2 interventions
Group B: No Bright Light Therapy via placebo glasses, Then Bright Light TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
15 weeks
2

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.

Time frame
15 weeks

Secondary outcomes

1

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.

Time frame
15 weeks
2

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.

Time frame
15 weeks

Other outcomes

Sponsors and contacts

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