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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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History
# Registration date Revision Id
2 2020-02-13, 1398/11/24 121813
1 2019-12-26, 1398/10/05 115435
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  • General information

    2019-11-20, 1398/08/29
    2020-06-18, 1399/03/29
    empty
    Sampling ends with a longer period of time.
    empty
    نمونه گیری در زمان طولانی تری به پایان می یابد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Soroush Special Clinic
    Name of recruitment center - Persian: درمانگاه تخصصی سروش
    Full name of responsible person - English: دکتر پژمان علوی نژاد
    Full name of responsible person - Persian: Pejman Alavinejad
    Street address - English: West Soroush Avenue, Kianpars
    Street address - Persian: کیانپارس، خیابان سروش غربی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 61357-15794
    Phone: +98 61 3391 6233
    Fax:
    Email: Pezhmanalavinejad@gmail.com
    Web page address:
    Name of recruitment center - English: Soroush Special Clinic
    Name of recruitment center - Persian: درمانگاه تخصصی سروش
    Full name of responsible person - English: Pezhman Alavinejad
    Full name of responsible person - Persian: دکتر پژمان علوی نژاد
    Street address - English: West Soroush Avenue, Kianpars.
    Street address - Persian: کیانپارس، خیابان سروش غربی.
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 61357-15794
    Phone: +98 61 3333 7908
    Fax:
    Email: Pezhmanalavinejad@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Alireza Ostadrahimi
    Full name of responsible person - Persian: دکتر علیرضا استاد رحیمی
    Street address - English: Faculty of Health and Nutrition, Tabriz University of Medical Sciences, Golghast St., Attar Neyshabouri St.
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده بهداشت و تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 7584
    Fax:
    Email: ostadrahimi@tbzmed.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Alireza Ostadrahimi
    Full name of responsible person - Persian: دکتر علیرضا استاد رحیمی
    Street address - English: Health and Nutrition Faculty, Tabriz University of Medical Sciences, Attar Neishabouri Avenue, Golghast Street.
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و بهداشت.
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 7584
    Fax:
    Email: ostadrahimi@tbzmed.ac.ir
    Web page address:

Protocol summary

Study aim
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)
Design
A randomized double-blind clinical trial, a parallel group design of 52 patients, followed for six weeks.
Settings and conduct
Participants will be recruited from outpatients attending Soroush Special Clinic in Ahvaz city, Iran.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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
Main outcome variables
Food intake, Severity of disease and Quality of life in patients with Irritable Bowel Syndrome

General information

Reason for update
Sampling ends with a longer period of time.
Acronym
IRCT registration information
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
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Mahsa Miryan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7584
Email address
miryan@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-31, 1398/05/09
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Except pharmacist, none of the participants and researchers will be aware of them until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neishabouri Avenue, Golgasht Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.TBZMED.REC.1398.473

Health conditions studied

1

Description of health condition studied
Irritable Bowel Syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
severity of Irritable bowel syndrome
Timepoint
At the beginning of the study and the sixth week of the intervention
Method of measurement
IBS Severity Index(IBSSI)

Secondary outcomes

1

Description
Quality of life in Patients with Irritable Bowel Syndrome
Timepoint
At the beginning of the study and the sixth week of the intervention
Method of measurement
Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL)

2

Description
Food intake in Patients with Irritable Bowel Syndrome
Timepoint
At the beginning of the study and the sixth week of the intervention
Method of measurement
3-Day Food Intake Record

Intervention groups

1

Description
Intervention group: Propolis extract at a dose of 500 mg per day for six weeks, taking 2 tablets daily.
Category
Treatment - Drugs

2

Description
Control group: Placebo at a dose of 500 mg per day for six consecutive weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Soroush Special Clinic
Full name of responsible person
Pezhman Alavinejad
Street address
West Soroush Avenue, Kianpars.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 7908
Email
Pezhmanalavinejad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Health and Nutrition Faculty, Tabriz University of Medical Sciences, Attar Neishabouri Avenue, Golghast Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
ostadrahimi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Miryan
Position
Masters student in Clinical Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Health and Nutrition Faculty, Attar Neishabouri Avenue, Golgasht street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 937 608 4602
Email
miryanm2014@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Health and Nutrition Faculty, Attar Neishabouri Avenue, Golgasht Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
ostadrahimi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Miryan
Position
Masters student in Clinical Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Health and Nutrition Faculty, Attar Neishabouri Avenue, Golgasht Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 937 608 4602
Email
miryanm2014@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be 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 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.
When the data will become available and for how long
The non-identifiable individual participant data will become available after the publication of the relevant articles.
To whom data/document is available
The non-identifiable individual participant data will become available to other researchers in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta analysis.
From where data/document is obtainable
The researchers (student and her supervisor)
What processes are involved for a request to access data/document
Request a document via email
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