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

Официальное название

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

Обзор

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).

Подробное описание

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). IBD affects over 1.5 million individuals in the US, so identifying risk factors for disease flares is essential to avoid complications, such as hospitalizations and surgery, and to improve quality of life (QoL). Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potentially modifiable risk factor.

Bright light therapy (BLT) in IBD patients with CM may decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL).In order to administer BLT efficiently and safely, a Re-Timer device, which is a lightweight, wearable set of glasses that emits blue-green light. Please note, the FDA has determined this device to be a General Wellness product and is not regulated by the FDA.

Prior to starting treatment, IBD patients will be screened for subclinical inflammation using a fecal calprotectin (FC) level and a blood test. If no subclinical inflammation is detected, potential subjects will be informed of their ineligibility. Eligible participants will complete questionnaires assessing their dietary habits, fatigue, sleep habits, quality of life, and severity of their underlying disease. Participants will also be provided a wrist actigraphy, which is a watch like device, to wear for 21 days to objectively assess CM prior to initiating therapy. 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. Prior to and following receiving BLT or non BLT placebo, the following samples will be obtained: i) serum markers of inflammation and endotoxemia, ii) urine samples to test for intestinal permeability, and iii) stool samples to assess intestinal microbiota. These proposed studies will assess whether BLT has an impact on IBD patients' inflammation, intestinal permeability, and intestinal microbiota.

Вмешательства

• Устройство Bright Light Therapy
  Device: Bright Light Therapy Retimer
• Устройство Placebo Retimer Device
  Device: Placebo Retimer Device with no bright light therapy

Первичные конечные точки

• Changes in intestinal permeability (% excretion of urinary sucralose) [Срок оценки: 15 weeks]
• Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA [Срок оценки: 15 weeks]

Вторичные конечные точки (2)

• Change in systemic markers of barrier disruption and inflammation [Срок оценки: 15 weeks]
• Change in systemic markers of inflammation [Срок оценки: 15 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 weeks prior to the study
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 2 центра

• Rush University Medical Center — Chicago
• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT05579392 · 22041302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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