Division of Gastroenterology and Hepatology, University of Michigan Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.
VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.
BMC Gastroenterol. 2024 May 22;24(1):179. doi: 10.1186/s12876-024-03263-2.
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.
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.
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.
The study protocol was registered on ClinicalTrials.gov as NCT06094608 on October 23, 2023, before recruitment began on February 1, 2024.
炎症性肠病（IBD）影响着超过 300 万的美国人，其具有反复发作和缓解的特点，尽管有免疫靶向治疗可用，但多达 30%的患者每年都会经历病情恶化。因此，迫切需要开发辅助治疗方法来更好地控制 IBD 症状和疾病活动。昼夜节律紊乱与疾病活动增加有关，可能是 IBD 的一个重要可调节治疗靶点。晨光治疗可提前和稳定昼夜节律，有可能改善 IBD 症状和疾病活动，但目前尚无研究探讨 IBD 中的这些潜在治疗益处。因此，在本研究中，我们旨在测试晨光治疗对 IBD 患者的有效性。
我们将招募 68 名经活检证实患有 IBD 且有临床症状的患者，并将其随机分为晨光治疗组或常规治疗组（TAU），两组的研究接触时间相同。在治疗前后，将评估患者报告的结局（IBD 相关生活质量、情绪、睡眠）、临床医生评估的疾病严重程度以及胃肠道炎症的生物标志物（粪便钙卫蛋白）。我们的主要目标将是测试晨光治疗与 TAU 对 IBD 相关生活质量的影响，次要目标将是测试其对临床医生评估的疾病活动、抑郁和睡眠质量的影响。我们还将探讨晨光治疗与 TAU 对胃肠道炎症生物标志物（粪便钙卫蛋白）的影响，以及类固醇使用、不宁腿综合征和生物性别对治疗效果的潜在调节作用。
晨光治疗可能是一种可接受、可行且有效的辅助治疗方法，适用于患有 IBD 且生活质量受损的患者。
该研究方案于 2023 年 10 月 23 日在 ClinicalTrials.gov 上注册，注册号为 NCT06094608，在 2024 年 2 月 1 日招募开始之前。
