The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis

Rush

Status

Completed

Conditions

Ulcerative Colitis

Treatments

Behavioral: 7-day sleep lab

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05180279

R01DK124280 (U.S. NIH Grant/Contract)

19051402

Details and patient eligibility

About

The purpose of this study is to investigate if circadian malalignment (unusual sleeping patterns), such as night shifts (sleeping during the day and being awake during the night time), worsens the inflammation of the gut. We hope to look at patients with Ulcerative Colitis and Healthy Controls.

Enrollment

19 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

UC patients:

M/F, 18-50 y/o
Inactive Disease (Mayo Score ≤ 2)
Stable medications with no disease flares for the > 3 months
Left-sided UC (Montreal E1 or E2)
Normal psychological evaluation and negative drug screen (See Below)

Healthy Controls:

M/F, 18-50 y/o, age ± 3y sex, race, and BMI match with UC subject
No clinical evidence of any medical illness
Normal psychological evaluation and negative drug screen (See Below)

Exclusion criteria

UC patients:

Patients with other forms of colitis such as Crohn's disease (CD) or indeterminate colitis
Patient with active UC (Mayo > 2)
Pancolonic UC (colitis past the splenic flexure, Montreal E3))
Use of biologic or immunomodulatory medications (i.e. Infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
Gastrointestinal surgery
Other GI diseases or systemic diseases (cardiac, renal failure, cirrhosis)
Shift work in the last 6 months
Antibiotic use within last 12 weeks
Patients who have used anti-diarrheal agents such as Lomotil or Imodium within 3 days of the study
Prednisone use the last 30 days
Significant Depression (score ≥ 14 BDI)
Significant Anxiety (score ≥ 40 STAI)
Use of probiotic supplement in last 4 weeks except yogurt.
Intentional change in diet.
Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed.
Chronic Alcohol use. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
Have children under 6 months

Healthy Controls:

History of drug abuse, gastrointestinal (GI) surgery, GI diseases, or systemic diseases such as renal (creatinine>1.2 mg/dl), liver, cardiac, or diabetes (Hgb-A1c>8%)
Antibiotic use within last 12 weeks
Shift work in the last 6 months
Use of probiotic supplement except yogurt in last 4 weeks.
Atypical American diet with daily fiber ≥ 16 grams or daily saturated fat ≤ 11 grams by Food Frequency Questionnaire
Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
Chronic Alcohol use. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
Significant Depression (score ≥ 14 BDI)
Significant Anxiety (score ≥ 40 STAI)
Regular use of medications that affect intestinal permeability, intestinal motility and/or endogenous melatonin including metoclopramide, NSAIDs, antibiotics, beta blocker, psychotropic medication, hypnotics and exogenous melatonin products during 4 weeks prior to the study
People who crossed more than 2 time zones in the previous month
Inability to sign an informed consent form.
Have children under 6 months