Objective: to evaluate the effects of pro-biotic yogurt ingestion on inflammation parameters, micro flora and intestinal permeability in patients with inflammatory bowel disease. Study design: double blind randomized placebo controlled trial. Study population: 210 patients with inflammatory bowel disease. Inclusion criteria: ulcerative colitis or crohn's disease patients; no history of using pro-biotic and pro-biotic supplements, antioxidant vitamin and omega-3 fatty acids supplements, using antibiotic drugs within last 3 months. Exclusion criteria: not interested to continue the study and need for change drug's doses or types during the study. Intervention: 250 grams of pro-biotic yogurt will be given daily to intervention group and 250 grams of non-pro-biotic yogurt daily to control group for two months. Primary study outcomes: IL-10, CRP, IL-6, IL-1 beta, TNF-alpha- intestinal permeability.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105106431N1
Registration date:2012-06-05, 1391/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-05, 1391/03/16
Registrant information
Name
Mahdi Shadnoush
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 1423
Email address
shadnoush@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-05-05, 1391/02/16
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic yogurt ingestion on inflammation parameters, micro flora and intestinal permeability in patients with inflammatory bowel disease
Public title
Effects of probiotic yogurt ingestion on inflammation and intestinal function in patients with inflammatory bowel disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- Ulcerative colitis or crohn's disease patients; 2- No history of using probiotic and prebiotic supplements within last 3 months; 3- No history of using antioxidant vitamin supplements within last 3 months; 4- No history of using omega-3 fatty acids supplements within last 3 months; 5- No history of using antibiotic drugs within last 3 months; 6- No history of other inflammatory diseases like rheumatoid arthritis and infectious disease; 7- No history of other gastrointestinal disease; 8- Body mass index(BMI) between 18.5 and 30; 9- No pregnancy and lactating stage in women; 10- Interested in participation and complete consent form. Exclusion criteria: 1-Not interested to continue the study; 2-Need for change drug's doses or types during the study.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Postal code
Approval date
2011-02-27, 1389/12/08
Ethics committee reference number
89-01-100-7384-5091
Health conditions studied
1
Description of health condition studied
Inflammatory bowel disease
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
2
Description of health condition studied
Inflammatory bowel disease
ICD-10 code
K50
ICD-10 code description
Crohn's disease
Primary outcomes
1
Description
IL-1beta
Timepoint
At baseline and at the end
Method of measurement
ELISA commercial kits
2
Description
TNF-alpha
Timepoint
At baseline and at the end
Method of measurement
ELISA commercial kits
3
Description
intestinal microflora
Timepoint
At baseline and at the end
Method of measurement
Real-time PCR
4
Description
Intestinal permability
Timepoint
At baseline and at the end
Method of measurement
HPLC
5
Description
IL-6
Timepoint
at baseline and at the end
Method of measurement
ELISA commercial kits
6
Description
CRP
Timepoint
At baseline and at the end
Method of measurement
ELISA commercial kits
7
Description
IL-10
Timepoint
At baseline and at the end
Method of measurement
ELISA commercial kits
Secondary outcomes
1
Description
dietary intake of different fatty acids
Timepoint
At baseline and at the end
Method of measurement
Nutritionist IV, a software program
2
Description
dietary intake of energy
Timepoint
At baseline and at the end
Method of measurement
Nutritionist IV, a software program
3
Description
dietary intake of macronutrient
Timepoint
At baseline and at the end
Method of measurement
Nutritionist IV, a software program
4
Description
dietary intake of cholestrol
Timepoint
At baseline and at the end
Method of measurement
Nutritionist IV, a software program
5
Description
dietary intake of antioxidant vitamins
Timepoint
At baseline and at the end
Method of measurement
Nutritionist IV, a software program
6
Description
dietary intake of fiber
Timepoint
At baseline and at the end
Method of measurement
Nutritionist IV, a software program
7
Description
dietary intake of calcium
Timepoint
At baseline and at the end
Method of measurement
Nutritionist IV, a software program
Intervention groups
1
Description
Control group: non-probiotic yogurt ingestion for 8 weeks (250 grams daily)