Protocol summary
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Study aim
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The effect of soybean consumption on disease severity, quality of life and hematologic factors in patients with ulcerative colitis
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Design
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A Randomized, controlled, parallel-group clinical trial on 40 patients with UC
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Settings and conduct
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Patients with UC will be recruited from Shariati and Imam Khomeini hospitals, Tehran, Iran. Then, patients will be assigned to intervention (soybean and routine treatment) and control (routine treatment) groups. Anthropometric measures and hematologic factors, disease severity , quality of life, disability caused by the disease will be assessed at the baseline and end of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with mild to moderate UC .
Individuals who are smokers, those consuming alcohol, taking multivitamin-minerals, are pregnant or lactating or decided to get pregnant during the next three months, those who have infection over the past three months will not be included. We also will not include individuals with other pathologic conditions affecting the intestine, including cancer and infectious diseases. If a participant gets pregnant during the study, consume alcohol and/or use tobacco, multivitamin-mineral, he or she will be excluded. Any changes in medications throughout the study will also result in the exclusion.
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Intervention groups
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Patients in the intervention group will be receive 30 g/day soybean along with routine treatments. Participants in the control group will be receive only routine treatments.
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Main outcome variables
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Disease severity, quality of life, hematologic factors
General information
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Reason for update
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Sampling has been delayed due to covid-19
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191113045432N1
Registration date:
2020-01-24, 1398/11/04
Registration timing:
prospective
Last update:
2020-06-02, 1399/03/13
Update count:
1
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Registration date
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2020-01-24, 1398/11/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-21, 1399/09/01
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Expected recruitment end date
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2021-03-21, 1400/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of soybean intake on disease severity, quality of life and hematologic factors of patients with ulcerative colitis
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Public title
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The effect of soybean intake on disease severity, quality of life and hematologic factors of patients with ulcerative colitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with colitits ulcerative with moderate severity
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
Admitting in hospital during last 3 months
History of gut infections during last 3 months
Using multivitamin/mineral supplements during last month
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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 35), 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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-23, 1398/06/01
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.506
Health conditions studied
1
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Description of health condition studied
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colitis ulcerative
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ICD-10 code
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K51.9
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ICD-10 code description
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Ulcerative colitis, unspecified
Primary outcomes
1
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Description
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Disease severity for colitis ulcerative
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Timepoint
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At the baseline and end of intervention
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Method of measurement
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Mayo-score questionnaire for colitis ulcerative
2
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Description
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Quality of life
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Timepoint
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At the baseline and end of intervention
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Method of measurement
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Questionnaire
3
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Description
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CBC
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Timepoint
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At the baseline and end of intervention
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Method of measurement
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Cell counter device
4
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Description
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ESR
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Timepoint
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At the baseline and end of intervention
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Method of measurement
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Wintergreen
5
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Description
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Disability caused by the disease
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Timepoint
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At the baseline and end of intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: daily intake of 30 g soybean produced by sobhan company along with routine treatment for colitis ulcerative patients
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Category
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Treatment - Other
2
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Description
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Control group: routine treatment for patients with colitis ulcerative
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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
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When the data will become available and for how long
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3 months after end of study
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To whom data/document is available
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The study findings will be made available to the general public
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Under which criteria data/document could be used
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For use in clinic or written a review article. For original studies, it will be permitted if they acknowledge our study personnel
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From where data/document is obtainable
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Using Email, by author who are responsible for updating data
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What processes are involved for a request to access data/document
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After receiving application by the author who are responsible for updating data and following consultation with scientific consultant, data will be provided
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Comments
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