Trial results for a study investigating the impact of circadian misalignment on Ulcerative Colitis were posted on ClinicalTrials.gov on 2025-08-19, with 19 participants enrolled.
Background
Ulcerative Colitis is a chronic inflammatory bowel disease that affects the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The exact cause is unknown, but it is believed to involve a combination of genetic, environmental, and immune factors. Current treatments aim to reduce inflammation and manage symptoms, but understanding contributing factors is crucial for comprehensive care. This study explored the potential role of circadian misalignment, such as unusual sleeping patterns or night shifts, in exacerbating gut inflammation in patients with Ulcerative Colitis.
Trial design
This completed study, designated as Phase NA, enrolled 19 participants, including both patients with Ulcerative Colitis and healthy controls. The investigation aimed to determine if circadian malalignment, characterized by sleeping during the day and being awake at night, could worsen gut inflammation. The study design focused on observing changes in physiological markers related to circadian rhythms and intestinal barrier function.
Key results
The trial reported several key measurements related to circadian rhythm markers and intestinal permeability:
- Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment:
- For the Healthy Control group, the mean DLMO was 20.72 hours (Standard Deviation 0.52) and 23.05 hours (Standard Deviation 0.48).
- For the Ulcerative Colitis group, the mean DLMO was 20.45 hours (Standard Deviation 1.08) and 22.65 hours (Standard Deviation 1.88).
- Change in Intestinal Permeability From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment:
- For the Healthy Control group, the mean change was 0.053 % excretion of oral dose 12-24 hr urinar (Standard Deviation 0.040) and 0.088 % excretion of oral dose 12-24 hr urinar (Standard Deviation 0.053).
- For the Ulcerative Colitis group, the mean change was 0.141 % excretion of oral dose 12-24 hr urinar (Standard Deviation 0.065) and 0.184 % excretion of oral dose 12-24 hr urinar (Standard Deviation 0.111).
What this means
The posted results provide data on how circadian misalignment affects both dim light melatonin onset and intestinal permeability in individuals with Ulcerative Colitis compared to healthy controls. The observed changes in intestinal permeability, particularly the mean values of 0.141% and 0.184% in the Ulcerative Colitis group under circadian misalignment, suggest a potential impact on gut barrier function. These findings contribute to understanding the physiological consequences of disrupted circadian rhythms in the context of inflammatory bowel disease, highlighting a possible environmental factor influencing disease activity.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05180279, titled "The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis", were posted on 2025-08-19 on clinicaltrials.gov.