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General information
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60
60
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2023-10-01, 1402/07/09
2023-10-01 00:00:00
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2024-12-22, 1403/10/02
2024-12-22 00:00:00
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2024-12-22, 1403/10/02
2024-12-22 00:00:00
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Completion of patient enrollment in the study
Completion of patient enrollment in the study
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تکمیل بیمار گیری مطالعه
تکمیل بیمار گیری مطالعه
Recruitment centers
#1
Name of recruitment center - English: مطب دکتر مختاری
Name of recruitment center - Persian: Dr. Mokhtari clinic
Full name of responsible person - English: Dr. Elham Mokhtari Amir Majdi
Full name of responsible person - Persian: دکتر الهام مختاری امیر مجدی
Street address - English: No. 11, Sajjad Boulevard, between Khayam boulevard and Golriz Street
Street address - Persian: بلوار سجاد، بین بلوار خیام و خیابان گلریز، ساختمان نگین، واحد ۱۱
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9178673799
Phone: +98 51 3760 3458
Fax:
Email: Emokhtaria@gmail.com
Web page address:
Name of recruitment center - English: Dr. Mokhtari clinic
Name of recruitment center - Persian: مطب دکتر مختاری
Full name of responsible person - English: Dr. Elham Mokhtari Amir Majdi
Full name of responsible person - Persian: دکتر الهام مختاری امیر مجدی
Street address - English: No. 11, Sajjad Boulevard, between Khayam boulevard and Golriz Street
Street address - Persian: بلوار سجاد، بین بلوار خیام و خیابان گلریز، ساختمان نگین، واحد ۱۱
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9178673799
Phone: +98 51 3760 3458
Fax:
Email: Emokhtaria@gmail.com
Web page address:
Name of recruitment center - English: مطب دکتر مختاریDr. Mokhtari clinic Name of recruitment center - Persian: Dr. Mokhtari clinicمطب دکتر مختاری Full name of responsible person - English: Dr. Elham Mokhtari Amir Majdi Full name of responsible person - Persian: دکتر الهام مختاری امیر مجدی Street address - English: No. 11, Sajjad Boulevard, between Khayam boulevard and Golriz Street Street address - Persian: بلوار سجاد، بین بلوار خیام و خیابان گلریز، ساختمان نگین، واحد ۱۱ City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9178673799 Phone: +98 51 3760 3458 Fax: Email: Emokhtaria@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. Toraj Zandbaf
Full name of responsible person - Persian: دکتر تورج زندباف
Street address - English: Dr. Shahinfar Medical Faculty - Islamic Azad University Of Mashhad, No. Imam Khomeini 14, Imam Khomeini St
Street address - Persian: خیابان امام خمینی، امام خمینی 14، دانشکده پزشکی دکتر شاهینفر - دانشگاه آزاد اسلامی مشهد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9178673799
Phone: +98 51 3225 0041
Fax:
Email: tooraj.zandbaf@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Toraj Zandbaf
Full name of responsible person - Persian: دکتر تورج زندباف
Street address - English: Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St
Street address - Persian: خیابان امام خمینی، امام خمینی 14، دانشکده پزشکی دکتر شاهینفر، دانشگاه آزاد اسلامی مشهد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9178673799
Phone: +98 51 3225 0041
Fax:
Email: tooraj.zandbaf@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Toraj Zandbaf Full name of responsible person - Persian: دکتر تورج زندباف Street address - English: Dr. Shahinfar Medical Faculty -; Islamic Azad University Of Mashhad, No. Imam Khomeini 14, Imam Khomeini St Street address - Persian: خیابان امام خمینی، امام خمینی 14، دانشکده پزشکی دکتر شاهینفر -، دانشگاه آزاد اسلامی مشهد City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9178673799 Phone: +98 51 3225 0041 Fax: Email: tooraj.zandbaf@gmail.com Web page address:
Protocol summary
Study aim
Evaluation of Vitamin B6 (pyridoxine) Effect on symptoms and quality of life in patients with irritable bowel syndrome (IBS) based on the Rome IV criteria.
Design
A randomized, double-blind, parallel-group clinical trial with a placebo-controlled study will be conducted on 60 patients for a duration of 4 weeks.
Settings and conduct
The study takes place at a private clinic in Mashhad city. After obtaining informed consent and checking entry and exit criteria, patients are assigned to treatment group A or B by concealed envelope method. Each patient will complete the IBSSS and IBS-QOL questionnaires. The patient is provided with the assigned medication code, and they receive a bottle of medication from category A or B from the pre-determined pharmacy. After 28 days, patients will be re-evaluated using the IBSSS and IBS-QOL. Until the data collection is complete, only the pharmacist is aware of the content of drug A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Newly diagnosed patients with Irritable Bowel Syndrome (IBS) according to the Rome IV criteria; Age from 18 to 65 years
Exclusion criteria:
Personal History of malignant diseases of the gastrointestinal tract; Celiac disease; Lactose intolerance; Diverticulitis; Gastrointestinal infection; Hypothyroidism and hyperthyroidism; Presence of other diseases during colonoscopy in individuals over 50 years of age; Pregnancy and lactation; Allergy to the study drug; Lack of consent to participate in the study
Intervention groups
Intervention group: Vitamin B6 (pyridoxine) tablet, 40 mg, every 12 hours for a duration of four weeks
Control group: Placebo tablet, 40 mg, every 12 hours for a duration of four weeks
Main outcome variables
Abdominal pain intensity, abdominal distension severity, satisfaction level with bowel movements, and quality of life of patients before and after intervention by using questionnaires.
General information
Reason for update
Completion of patient enrollment in the study
Acronym
PIBS
IRCT registration information
IRCT registration number:IRCT20211226053534N2
Registration date:2023-08-12, 1402/05/21
Registration timing:prospective
Last update:2025-01-07, 1403/10/18
Update count:1
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Elham Mokhtari Amirmajdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 316 5096
Email address
emokhtaria@mshdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
2023-10-01, 1402/07/09
Actual recruitment end date
2024-12-22, 1403/10/02
Trial completion date
2024-12-22, 1403/10/02
Scientific title
Evaluation of Vitamin B6 (pyridoxine) Effect on symptoms and quality of life in patients with irritable bowel syndrome (IBS)
Public title
Evaluation of Vitamin B6 (pyridoxine) Effect on symptoms and quality of life in patients with irritable bowel syndrome (IBS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed patients with Irritable Bowel Syndrome (IBS) according to the Rome IV criteria
Age from 18 to 65 years old
Exclusion criteria:
Personal History of malignant diseases of the gastrointestinal tract, Celiac disease, Lactose intolerance, Diverticulitis, Gastrointestinal infection, Hypothyroidism and hyperthyroidism
Presence of other diseases during colonoscopy in individuals over 50 years of age
Pregnancy and lactation
Allergy to the study drug
Lack of consent to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the two study arms and three categories of IBS (predominant constipation, diarrhea, or mixed) diagnosed using the Rome IV criteria, a randomization list is created using an online randomization software in blocks of six. Through this method, a unique code is generated for each individual. Each code, along with the medication category A or B, is placed in a sealed envelope. Upon the individual's entry into the study and in the order specified by the randomization list, the envelope is opened by the diagnosing physician, and the patient is randomly assigned to either the treatment group receiving drug A or drug B. Both the physician and the patient are blinded to the content of drugs A and B. The patient is provided with the assigned medication code, and they receive a bottle of medication from category A or B from the pre-determined pharmacy, which holds these bottles.
Blinding (investigator's opinion)
Double blinded
Blinding description
Until the end of data collection, only the pharmacist will be aware of the content of drugs A and B, and until that time, all participants and researchers will remain blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad Medical Science Islamic Azad University
Street address
Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.IAU.MSHD.REC.1402.043
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
Irritable bowel syndrome severity
Timepoint
At beginning of the study and four weeks after initiation of the study
Method of measurement
The irritable bowel severity scoring system (IBSSS)
Secondary outcomes
1
Description
Quality of life in patients with irritable bowel syndrome
Timepoint
At beginning of the study and four weeks after initiation of the study
Method of measurement
Irritable bowel syndrome quality of life questionnaire (IBS-QOL)
Intervention groups
1
Description
Intervention group: Vitamin B6 (pyridoxine) tablet, 40 mg, every 12 hours for a duration of four weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo tablet, 40 mg, every 12 hours for a duration of four weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mokhtari clinic
Full name of responsible person
Dr. Elham Mokhtari Amir Majdi
Street address
No. 11, Sajjad Boulevard, between Khayam boulevard and Golriz Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 51 3760 3458
Email
Emokhtaria@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Toraj Zandbaf
Street address
Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 51 3225 0041
Email
tooraj.zandbaf@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammad Mahdi Azizian
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 991 455 3005
Fax
Email
dpusaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Mokhtari Amirmajdi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 915 316 5096
Fax
Email
Emokhtaria@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mahdi Azizian
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 991 455 3005
Email
dpusaz@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 statistical data of the participants will be shared collaboratively.
When the data will become available and for how long
Access will be provided upon publication of the relevant study articles.
To whom data/document is available
Researchers at scientific institutions.
Under which criteria data/document could be used
Studies in the field of irritable bowel syndrome.
From where data/document is obtainable
To receive the documents via email, please send your request and the reason for it to person responsible for general inquiries of the study. After reviewing it in the shortest possible time, a response to your request will be sent. Email address: dpusaz@gmail.com
What processes are involved for a request to access data/document