General purpose
Determining the effect of postbiotic Butyrate supplementation on the expression of anti-inflammatory genes Sirt1 and Pgc1alpha and apoptosis genes Bax and Bcl2 and quality of life and anthropometric indicators in Ulcerative colitis patients.
Functional goal
Use of postbiotic Butyrate dietary supplement to improve inflammation and quality of life in patients with Ulcerative colitis.
Design
A clinical trial with a double-blind control group was randomized on 30 patients and block randomization was used for randomization.
Settings and conduct
Patients referred to Shiraz Faqihi Hospital with mild to moderately active ulcerative colitis.
Blood samples, anthropometric indicators and IBDQ9 quality of life questionnaire will be taken from the participants at the beginning and end of the study. Finally, the expression level of Bax, Bcl2, Sirt1, genes will be measured by RT-PCR method. Participants will be divided using block randomization method and patient and researcher will be blinded in this study
Participants/Inclusion and exclusion criteria
Inclusion: Patients with mild to moderate Ulcerative colitis aged 18 to 60 years
exclusion: pregnancy and breastfeeding and other gastrointestinal diseases and consumption of other probiotic and antibiotic supplements and changes in the process of taking drugs during the study
Intervention groups
The intervention group was supplemented with sodium Butyrate 600 mg per day for 12 weeks and the control group with starch 600 mg per day for 12 weeks.
Main outcome variables
The primary outcomes will be measuring the expression of Bax, Bcl2, Sirt1, and Pgc1alpha genes at the beginning and end of the study in both groups, and the secondary outcome will be the assessment of quality of life using the IBDQ9 questionnaire in both groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221215056828N1
Registration date:2023-09-03, 1402/06/12
Registration timing:registered_while_recruiting
Last update:2023-09-03, 1402/06/12
Update count:0
Registration date
2023-09-03, 1402/06/12
Registrant information
Name
Mohammad Vatanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4434 8659
Email address
amirvatanpour24@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-24, 1402/06/02
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Butyrate on anti inflammatory genes Sirt1 and Pgc1alpha and apoptosis gene Bax and Bcl2 in Ulcerative colitis patients
Public title
Investigating the effect of Butyrate on inflammatory genes and apoptosis in Ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female 18 to 60 years old
Body mass index between 18.5 and 30
Estimating the severity of the disease based on the Mayo
The severity of the disease is mild to moderate
Patients with ulcerative colitis diagnosed by colonoscopy
Informed consent from the patient
Patients who are in the quiescent stage of the disease are included in the study, and patients who are in the acute stage of the disease are excluded.
The patient should refrain from any self treatment and use of herbal medicines.
Exclusion criteria:
Patients with other gastrointestinal diseases including intestinal obstruction, fistula, celiac disease, cancer and infectious diseases
Pregnancy and breastfeeding
Use of antibiotic drugs and other probiotic products and vitamin and mineral supplements for the previous 2 months.
History of hospitalization in the last 3 months
Type 2 diabetes patients
Acute stage of the disease
Change in the process of drug consumption during the study
Intensification of the disease during study
The place of implementation of the study is Faqihi Hospital and Motahari Clinic of Shiraz University of Medical Sciences
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The use of block randomization method, eligible candidates are randomly divided into two groups through 5 blocks of six numbers, in each block there are three volunteers of the intervention group and three volunteers of the placebo group in different order.
Blinding (investigator's opinion)
Double blinded
Blinding description
By a third party who is not involved in the study and is completely unaware of the details of the study, the supplement and placebo are divided and numbered in containers of the same shape.The statistical consultant determines the random sequence and enters the participants into the study and assigns the participants to the intervention groups. The study participants and the researcher are blinded, and a third person outside the study, who is not aware, specifies the codes a and b
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Facility of Nutrition, Razi Blv, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7153675500
Approval date
2023-07-29, 1402/05/07
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.057
Health conditions studied
1
Description of health condition studied
Ulcerative Colitis Inflammation
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Changes in gene Sirt1 expression
Timepoint
At the beginning of the study and 3 months later (the end of the study)
Method of measurement
Real time PCR
Secondary outcomes
1
Description
Life quality score
Timepoint
At the beginning of the study and 3 months later (the end of the study)