The effects of soy milk consumption on microbiota, inflammatory markers, quality of life, symptoms and disease severity in patients with colitits ulcerative
The effect of soy milk consumption on inflammatory biomarkers, gut microbiota, disease severity and symptoms in patients with ulcerative colitis (UC)
Design
Randomized controlled clinical trial with a parallel group design on 30 patients with UC
Settings and conduct
Patients with UC will be recruited from Shariati and Imam Khomeini hospitals, Tehran, Iran. Then, patients will be assigned to intervention (soy milk and routine treatment) or control (routine treatment) groups. Anthropometric measures and biochemical factors will be assessed at the baseline and end of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients with UC with moderate severity
BMI between 18.5 and 30
Not-inclusion criteria
Alteration in type of drugs used for treatment of IBD within last 3 months
Having other gut diseases such as related cancers and infections
Pregnancy and lactation
Antibiotic use during last month
Consumption of probiotic products during last month
Admitting in hospital during last 3 months
History of gut infections during last 3 months
Intervention groups
Patients in the intervention group will receive 200 mL/day soy milk along with routine treatments. Participants in the control group will receive only routine treatments.
The effects of soy milk consumption on microbiota, inflammatory markers, quality of life, symptoms and disease severity in patients with colitits ulcerative
Public title
The effects of soy milk consumption on gut microbium community, inflammatory markers, quality of life, symptoms and disease severity in patients with colitits ulcerative
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with colitits ulcerative with moderate severity
body mass index between 18.5 and 30
Exclusion criteria:
Alteration in type of drugs used for treatment of IBD within last 3 months
Having other gut diseases such as related cancers and infections
Pregnancy and lactation
Antibiotic use during last month
Consumption of probiotic products during last month
Admitting in hospital during last 3 months
History of gut infections during last 3 months
Using multivitamin/mineral supplements during last month
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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be stratified based on age (20 to 40 and 40 to 60 years), gender (male/female), body mass index (18.5 to 24.9 and 25 to 30), and type of medicines (anti-inflammatory and immunosuppressant) into dual blocks, and will be randomly allocated to the intervention or control groups. Random allocation will be done by lottery by a person who is unaware about the aim of our study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Flat. 6, Office Building of Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417933331
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
IR.TUMS.VCR.REC.1397.445
Health conditions studied
1
Description of health condition studied
colitis ulcerative
ICD-10 code
K51.9
ICD-10 code description
Ulcerative colitis, unspecified
Primary outcomes
1
Description
gut microbiota community
Timepoint
at the baseline and end of intervention
Method of measurement
real-time PCR method
2
Description
fecal calpotectin
Timepoint
at the baseline and end of intervention
Method of measurement
ELISA
3
Description
fecal lactoferrin
Timepoint
at the baseline and end of intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
serum hs-CRP levels
Timepoint
at the baseline and end of intervention
Method of measurement
ELISA
2
Description
disease severity for colitis ulcerative
Timepoint
at the baseline and end of intervention
Method of measurement
mayo-score questionnaire for colitis ulcerative
3
Description
disease symptoms such as diarrhea, presence of blood in stool and stomachache
Timepoint
at the baseline and end of trial
Method of measurement
questionnaire
4
Description
serum TNF-a levels
Timepoint
at the baseline and end of trial
Method of measurement
ELISA
5
Description
serum IL-1B levels
Timepoint
at the baseline and end of trial
Method of measurement
ELISA
6
Description
patients quality of life
Timepoint
at the baseline and end of trial
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: daily intake of 200 ml soy milk produced by mandasoy company along with routine treatment for colitis ulcerative patients
Category
Treatment - Other
2
Description
Control group: routine treatment for patients with colitis ulcerative
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr. Alireza Sima
Street address
Shariati hospital, Kargar Shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Dr. Alireza Sima
Street address
Emam Khomeini hospital, Dr. Gharib Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 3007
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Azadbakht
Street address
No. 44, Hojatdost Ave, Naderi Ave, Keshavarz Blvd, Tehran city
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5742
Email
Info_snsd@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Position
Ph.D student of nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 44, Hojatdost Ave, Naderi Ave, Keshavarz Blvd, Tehran city
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5742
Email
omidsadeghi69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Position
Ph.D student of nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 44, Hojatdost Ave, Naderi Ave, Keshavarz Blvd, Tehran city
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5742
Email
omidsadeghi69@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Position
Ph.D student of nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 44, Hojatdost Ave, Naderi Ave, Keshavarz Blvd, Tehran city
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5742
Email
omidsadeghi69@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol will be written and published in the form of an article. Clinical report of our study will be published after finishing data gathering
When the data will become available and for how long
3 months after end of study
To whom data/document is available
The study findings will be made available to the general public
Under which criteria data/document could be used
For use in clinic or written a review article. For original studies, it will be permitted if they acknowledge our study personnel
From where data/document is obtainable
Using Email, by author who are responsible for updating data
What processes are involved for a request to access data/document
After receiving application by the author who are responsible for updating data and following consultation with scientific consultant, data will be provided