Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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Completion of patient enrollment in the study
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Acronym
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PIBS
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IRCT registration information
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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
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Registration date
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2023-08-12, 1402/05/21
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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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2023-09-06, 1402/06/15
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Expected recruitment end date
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2024-05-04, 1403/02/15
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Actual recruitment start date
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2023-10-01, 1402/07/09
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Actual recruitment end date
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2024-12-22, 1403/10/02
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Trial completion date
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2024-12-22, 1403/10/02
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Scientific title
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Evaluation of Vitamin B6 (pyridoxine) Effect on symptoms and quality of life in patients with irritable bowel syndrome (IBS)
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Public title
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Evaluation of Vitamin B6 (pyridoxine) Effect on symptoms and quality of life in patients with irritable bowel syndrome (IBS)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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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
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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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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2023-07-19, 1402/04/28
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Ethics committee reference number
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IR.IAU.MSHD.REC.1402.043
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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Irritable bowel syndrome severity
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Timepoint
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At beginning of the study and four weeks after initiation of the study
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Method of measurement
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The irritable bowel severity scoring system (IBSSS)
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 beginning of the study and four weeks after initiation of the study
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Method of measurement
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Irritable bowel syndrome quality of life questionnaire (IBS-QOL)
Intervention groups
1
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Description
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Intervention group: Vitamin B6 (pyridoxine) tablet, 40 mg, every 12 hours for a duration of four weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo tablet, 40 mg, every 12 hours for a duration of four 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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Islamic Azad University
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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 statistical data of the participants will be shared collaboratively.
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When the data will become available and for how long
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Access will be provided upon publication of the relevant study articles.
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To whom data/document is available
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Researchers at scientific institutions.
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Under which criteria data/document could be used
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Studies in the field of irritable bowel syndrome.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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Through email.
dousaz@gmail.com
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Comments
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