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

The aim of this study was to evaluate the effect of postbiotic butyrate supplementation on the expression of circadian genes, inflammation, sleep quality and psychological factors in patients with ulcerative colitis.

In a randomized controlled clinical trial study of double blinded parallel in phase 4, 30 people were divided into two groups of intervention and control.

Thirty new patient in the active phase with low to moderate colitis severity will be selected for this study through colonoscopy from Namazi hospital. Patients are randomly divided into intervention or control groups. Participants receive butyrate or starch capsules, marked A or B to blind participants and staff, based on the assigned group. Anthropometric indices, questionnaires, blood samples, stool samples will be taken at start and the end of the study from the patients. To evaluate patients' diets, three 24-hour diet recalls will be taken during the intervention.

Inclusion criteria: New adult patients 20 to 60 years with low to moderate disease severity. Exclusion criteria: Patients with intestinal obstruction, fistula, cancer, type 2 diabetes, infectious diseases, pregnancy or lactation, use of antibiotics in the past two weeks and prebiotic or probiotic products, vitamin and mineral supplements in the past month and Psychological drugs, changes in the type or dose of drugs.

Participants are divided into two groups of intervention and control. In the intervention group, people received butyrate and starch capsule at dose of 600 mg once a day for 12 weeks with dietary recommendations for UC in the intervention and control groups respectively.

The main primary variables in the present study were the expression of circadian rhythm genes including (CRY2, Bmal1 and CLOCK) and fecal calprotectin levels.

Thirty eligible individuals are divided into 2 groups by block randomization method. The blocks are made by an out-of-study person and the assignment group is placed in a sealed envelope for each individual. After entering the study, by opening the envelope, the person will be informed of the assigned group, which are named with the letters A or B.

In this double-blind randomized controlled trial, a person outside the study labels butyrate and placebo supplements with the letters A or B for blinding. Supplements and placebos are similar in appearance and physical properties. Assignment groups are also named based on the name assigned to the supplement and placebo. As a result, participants and researchers become blind. Also, people who evaluate the consequences and analyze the data will be blind to the groups. It should be noted that at the beginning of the study, participants are informed that they are in one of the supplement or placebo groups.