Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05579392
Other study ID # 22041302
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 22, 2022
Est. completion date May 31, 2025

Study information

Verified date April 2024
Source Rush University Medical Center
Contact Daynia Sanchez-Bass
Phone (312) 563-4981
Email daynia_sanchez-bass@rush.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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) 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).


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 31, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Biopsy proven diagnosis of Crohn's or Ulcerative Colitis 2. 18 years or older 3. Fecal Calprotectin > 50 or CRP above upper limit of normal or a PROMISE Fatigue = 50 4. Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks Exclusion Criteria: 1. Active IBD (Harvey Bradshaw Index > 5 or Modified Harvey Bradshaw Index >5) 2. Major depression (score = 21 or any endorsement of suicidal intent on the Beck Depression) 3. Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43) 4. Restless leg syndrome (score = 15 on the IRLS Study Group Rating Scale(44)) 5. 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 6. People who have worked night shifts or crossed more than 2 time zones in the previous month 7. 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) 8. Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening 9. Inability to sign an informed consent

Study Design


Intervention

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

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Rush University Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in intestinal permeability (% excretion of urinary sucralose) Participants will ingest a sugar cocktail at Visits 2-5 and complete a urine collection. Measurement of urinary sugars is done using gas chromatography is used to calculate intestinal permeability. 15 weeks
Primary Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA At all study visits, stool samples will be collected and analyzed using shotgun metagene sequencing and total microbial community DNA will be isolated and processed for microbiome analysis. 15 weeks
Secondary Change in systemic markers of barrier disruption and inflammation Inflammatory cytokines (IL-6, TNF-a, and IL-8) are the markers of disruption. IL-6, IL-8, and TNF-a will be measured in the plasma. 15 weeks
Secondary Change in systemic markers of inflammation markers of endotoxemia (LPS, LBP, and sCD14) will be used to assess inflammation. Lipopolysaccharide binding protein(LBP) and sCD14 will be measured in serum by high sensitivity ELISA. Lipopolysaccharide (LPS) will be measured in serum using a LAL assay which is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin. 15 weeks
See also
  Status Clinical Trial Phase
Withdrawn NCT03278912 - Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Completed NCT03264690 - Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
Recruiting NCT02861053 - Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ? N/A
Recruiting NCT02275676 - Resting Energy Expenditure and Nutritional Status in IBD N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02161640 - Vascular Dysfunction in Paediatric IBD N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT01852760 - Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound N/A
Completed NCT01860651 - Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease N/A
Completed NCT01933867 - Water-aided Colonoscopy in Inflammatory Bowel Disease Patients N/A
Completed NCT01666535 - Infliximab IBD Influenza Vaccine Study N/A
Completed NCT01692743 - Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD) Phase 3
Completed NCT01688557 - Trial on Innovative Technologies in Colonoscopy N/A
Completed NCT01676324 - FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD) N/A
Completed NCT01981616 - Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab Phase 1
Completed NCT01557387 - Real-time Diagnosis of Pseudopolyps During Colonoscopy
Completed NCT01221818 - A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects Phase 1
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT02322008 - Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice N/A