Protocol summary
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Study aim
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Effect of Bee Food Supplement Propolis on Food intake, Severity of disease and Quality of life in Patients with Irritable Bowel Syndrome (based on RomeIV criteria)
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Design
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A randomized double-blind clinical trial, a parallel group design of 52 patients, followed for six weeks.
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Settings and conduct
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Participants will be recruited from outpatients attending Soroush Special Clinic in Ahvaz city, Iran.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients diagnosed irritable bowel syndrome with Rome IV criteria, fill out written consent form, having no allergy to bee products
Non-arrival conditions: having pregnancy or lactation, having malignancy or other chronic diseases of the gastrointestinal tract, having regular use of gastrointestinal modifying drugs, having regular use of laxatives, having a history of major surgery in the digestive system, following dietary plans, having a regular daily intake of Prebiotic / Probiotics, consumption of antibiotics, usage of psychotherapeutic drugs, including depression and anxiety drugs.
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Intervention groups
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Propolis extract at a dose of 500 mg per day for six weeks.
Control group: Placebo at a dose of 500 mg per day for four consecutive months
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Main outcome variables
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Food intake, Severity of disease and Quality of life in patients with Irritable Bowel Syndrome
General information
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Reason for update
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Sampling ends with a longer period of time.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190708044154N1
Registration date:
2019-12-26, 1398/10/05
Registration timing:
registered_while_recruiting
Last update:
2020-02-13, 1398/11/24
Update count:
1
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Registration date
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2019-12-26, 1398/10/05
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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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2019-07-31, 1398/05/09
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Expected recruitment end date
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2020-06-18, 1399/03/29
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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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Effect of Bee Food Supplement Propolis on Food intake, Severity of disease and Quality of life in Patients with Irritable Bowel Syndrome (based on RomeIV criteria): a Randomized Double-Blind Clinical Trial
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Public title
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Effect of Bee Food Supplement Propolis on Food intake, Severity of disease and Quality of life in Patients with Irritable Bowel Syndrome (based on RomeIV criteria): a Randomized Double-Blind Clinical Trial
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients diagnose irritable bowel syndrome with Rome IV criteria
Filling out the written consent form
Not having allergy to bee products
Exclusion criteria:
Pregnant or lactating women
Cases of malignancy or other chronic digestive diseases such as inflammatory bowel disease and celiac disease
Regular use of drugs that modify gastrointestinal movements such as metoclopramide, cisapride, narcotics, diphenoxylate, etc.
Regular use of laxatives
History of major surgery in the digestive system (including Billroth's operating, having any Ostomy and resection of any part of the digestive tract).
Following diet plans
Individuals with daily and regular use of Prebiotic/ probiotic compounds
Consumption antibiotics
People who use psychotherapeutic drugs, including depression and anxiety.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
52
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Stratified block randomization, The type of blindness in our study will be double-blind. Prior to the onset of the study, the box containing the relevant pills is coded A and B by Pharmacist, in order to blind the researcher about which supplement each group received. In this study, the patients and researchers will not be aware of the allocation concealment until the end of the study.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Except pharmacist, none of the participants and researchers will be aware of them until the end of the study.
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Placebo
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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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2019-07-28, 1398/05/06
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Ethics committee reference number
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IR.TBZMED.REC.1398.473
Health conditions studied
1
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Description of health condition studied
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Irritable Bowel Syndrome
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ICD-10 code
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K58
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ICD-10 code description
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Irritable bowel syndrome
Primary outcomes
1
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Description
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severity of Irritable bowel syndrome
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Timepoint
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At the beginning of the study and the sixth week of the intervention
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Method of measurement
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IBS Severity Index(IBSSI)
Secondary outcomes
1
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Description
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Quality of life in Patients with Irritable Bowel Syndrome
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Timepoint
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At the beginning of the study and the sixth week of the intervention
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Method of measurement
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Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL)
2
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Description
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Food intake in Patients with Irritable Bowel Syndrome
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Timepoint
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At the beginning of the study and the sixth week of the intervention
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Method of measurement
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3-Day Food Intake Record
Intervention groups
1
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Description
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Intervention group: Propolis extract at a dose of 500 mg per day for six weeks, taking 2 tablets daily.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo at a dose of 500 mg per day for six consecutive weeks.
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Category
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Placebo
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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Tabriz 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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Yes - There is 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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Undecided - It is not yet known if there will be 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 non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.
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When the data will become available and for how long
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The non-identifiable individual participant data will become available after the publication of the relevant articles.
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To whom data/document is available
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The non-identifiable individual participant data will become available to other researchers in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by other researchers, for conducting Meta analysis.
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From where data/document is obtainable
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The researchers (student and her supervisor)
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What processes are involved for a request to access data/document
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Request a document via email
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Comments
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