RECRUITING

A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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) 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).

Official Title

Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

Quick Facts

Study Start:2022-09-22

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05579392

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Daynia Sanchez-Bass

CONTACT

(312) 563-4981

daynia_sanchez-bass@rush.edu

Principal Investigator

Ali Keshavarzian, M.D.

PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Garth R Swanson, M.D.

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Rush University Medical Center

Chicago, Illinois, 60068

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

Ali Keshavarzian, M.D., PRINCIPAL_INVESTIGATOR, Rush University Medical Center
Garth R Swanson, M.D., PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-22

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2022-09-22

Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

Inflammatory Bowel Disease