Morning light treatment for inflammatory bowel disease: a clinical trial

Abstract

Background: Inflammatory bowel disease (IBD) affects over 3 million Americans and has a relapsing and remitting course with up to 30% of patients experiencing exacerbations each year despite the availability of immune targeted therapies. An urgent need exists to develop adjunctive treatment approaches to better manage IBD symptoms and disease activity. Circadian disruption is associated with increased disease activity and may be an important modifiable treatment target for IBD. Morning light treatment, which advances and stabilizes circadian timing, may have the potential to improve IBD symptoms and disease activity, but no studies have explored these potential therapeutic benefits in IBD. Therefore, in this study, we aim to test the effectiveness of morning light treatment for patients with IBD.

Methods: We will recruit sixty-eight individuals with biopsy-proven IBD and clinical symptoms and randomize them to 4-weeks of morning light treatment or 4-weeks of treatment as usual (TAU), with equivalent study contact. Patient-reported outcomes (IBD-related quality of life, mood, sleep), clinician-rated disease severity, and a biomarker of gastrointestinal inflammation (fecal calprotectin) will be assessed before and after treatment. Our primary objective will be to test the effect of morning light treatment versus TAU on IBD-related quality of life and our secondary objectives will be to test the effects on clinician-rated disease activity, depression, and sleep quality. We will also explore the effect of morning light treatment versus TAU on a biomarker of gastrointestinal inflammation (fecal calprotectin), and the potential moderating effects of steroid use, restless leg syndrome, and biological sex.

Discussion: Morning light treatment may be an acceptable, feasible, and effective adjunctive treatment for individuals with active IBD suffering from impaired health-related quality of life.

Trial registration: The study protocol was registered on ClinicalTrials.gov as NCT06094608 on October 23, 2023, before recruitment began on February 1, 2024.

Keywords: Crohn’s disease; Light treatment; Sleep; Ulcerative colitis.

Fig. 1

A conceptual model illustrating that morning light treatment, which is known to improve mood and sleep and to reduce circadian disruption, may also reduce intestinal inflammation and clinical disease activity, all with potential to ultimately improve IBD-related quality of life. The measure used to assess each domain is shown in italics: Patient Health Questionnaire (PHQ-9), Morningness-Eveningness Questionnaire (MEQ), PROMIS Sleep Disturbance 8b, Harvey Bradshaw Index (HBI), Simple Clinical Colitis Activity Index (SCCAI), and Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

Fig. 2

A diagram of the 5-week study protocol for a participant with an average sleep schedule of 11pm to 7am who is assigned to the morning light treatment. During visit 2 (V2), participants receive a wrist actigraphy monitor and are instructed on how to complete daily logs while sleeping ad lib at home. A week later at visit 3 (pre-treatment, V3) participants bring in a stool sample collected at home the day before, outcome measures are collected (including the clinical disease activity assessment represented by the dark rectangle), and participants are randomized to morning light treatment or treatment as usual (TAU). During weekly visits (V4, V5, V6) participants’ adherence to the light treatment and sleep schedule are checked (if assigned to morning light treatment) and daily logs and side effects are reviewed (both groups). A week later during visit 7 (post-treatment, V7) participants bring in a stool sample collected at home the day before, and post-treatment outcome measures are collected again. The TAU study protocol looks similar to this morning light treatment protocol except the ad lib sleep during the first week of the study continues throughout the 5 week study protocol. The anticipated duration of each study visit is shown