?Effect of butyrate in ulcerative colitis

Evaluation the effect of postbiotic butyrate supplementation on the expression of circadian genes, inflammation, sleep quality and psychological factors in patients with ulcerative colitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211214053401N1

Enrollment

Registered

2022-01-02

Start date

2022-01-21

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis.

Interventions

Intervention 1: Intervention group: The patients take butyrate capsules at a dose of 600 mg once a day for 12 weeks with dietary recommendations for IBD patients that take it with the main meal. Butyr

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: New case Mild to moderate UC Active phase of diseases

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDonya Firoozi

Shiraz University of Medical Sciences

donyafiroozi@gmail.com+98 71 3725 1005

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026