?Effect of butyrate in ulcerative colitis
Phase 4
- Conditions
- lcerative Colitis.
- Registration Number
- IRCT20211214053401N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
New case
Mild to moderate UC
Active phase of diseases
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expression of circadian genes including (CRY2, Bmal1 and CLOCK). Timepoint: At the beginning of the study and 12 weeks later (end of the study). Method of measurement: Blood samples will be taken from patients to evaluate the expression of circadian rhythm genes. After isolation of peripheral blood mononuclear cells, the expression of circadian genes (CRY2, Bmal1 and CLOCK) will be evaluated by RT-PCR.;Calprotectin. Timepoint: At the beginning of the study and 12 weeks later (end of the study). Method of measurement: For determination of fecal calprotectin level, 20 g of fecal sample will be taken from patients in the early morning and fecal calprotectin level will be measured using special commercial kits.
- Secondary Outcome Measures
Name Time Method Serum level of hs-CRP. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: ELIZA commercial kit.;Sleep quality. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: PSQI questionnaire.;Depression and anxiety. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: HADS (Hospital anxiety depression scale) questionnaire.;Stress. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: general health questionnaire.;Life quality. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: IBDQ-9 self-management questionnaire.;AST and ALT. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: commercial kit.