Treatment for Inflammatory Bowel Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Inflammatory Bowel DiseaseBright Light Therapy - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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, QoL, 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.

Eligible Conditions
  • Inflammatory Bowel Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 15 weeks

15 weeks
Inflammation
Inflammation
Hematuria
Body Weight Changes

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Bright Light Therapy via ReTimer glasses, Then Placebo
1 of 2
No Bright Light Therapy via placebo glasses, Then Bright Light Therapy
1 of 2

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment · Has Placebo Group · N/A

Bright Light Therapy via ReTimer glasses, Then PlaceboExperimental Group · 2 Interventions: Bright Light Therapy, Placebo Retimer Device · Intervention Types: Device, Device
No Bright Light Therapy via placebo glasses, Then Bright Light TherapyExperimental Group · 2 Interventions: Bright Light Therapy, Placebo Retimer Device · Intervention Types: Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bright Light Therapy
2010
Completed Early Phase 1
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 15 weeks

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
390 Previous Clinical Trials
153,554 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a biopsy-proven diagnosis of Crohn's or Ulcerative Colitis.
Fecal calprotectin > 50 or CRP > 5 or a FACIT Score ≥ 4.
You must be at least 18 years old.\n