Assessing the effect of gluten-free diet on clinical symptoms of patients with irritable bowel syndrome.
Design
A randomized, open label clinical trial on 44 patients. Groups include intervention and control groups. Patients will be randomly allocated to the groups using simple randomization method with random number table.
Settings and conduct
Participants will be selected from patients of Urmia Imam Khomeini gastrointestinal outpatient clinic and will be allocated randomly to the intervention and control groups. Demographic information and symptoms will be entered to checklist forms at the beginning of the study and patients symptoms will be reevaluated after 4 weeks. Because both patients and researchers are aware of diet type the study will be open labeled (not blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having Irritable bowel syndrome (IBS) according to ROME-IV diagnostic criterion; Having Irritable bowel syndrome (IBS) according to ROME-IV diagnostic criterion; Having informed consent and ability of participation in study and adherence to gluten free die; Being at least 18 years old.
Non-inclusion criteria: Having inflammatory, infectious or organic gastrointestinal disease;
Having coeliac disease.
Intervention groups
In intervention group gluten free diet will be prescribed and necessary information and education about the gluten free diet will be provided. In control group patients will continue their normal diet. All patients will receive standard treatment according to their symptoms.
Main outcome variables
Abdominal Pain;
Constipation;
Diarrhea;
Abdominal Distention or Flatulence;
Nausea and/or vomiting;
Effect of disease on daily life;
mental well-being;
fecal urgency;
incomplete defecation sense.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201204049599N1
Registration date:2021-02-13, 1399/11/25
Registration timing:retrospective
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Mohammad Reza Pashaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3198 8001
Email address
pashaee.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
2020-01-21, 1398/11/01
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2020-08-22, 1399/06/01
Scientific title
Comparison of the effect of gluten free diet and regular diet on severity of clinical symptoms in patients with irritable bowel syndrome
Public title
Effect of gluten free diet on irritable bowel syndrome symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Irritable bowel syndrome (IBS) according to ROME-IV diagnostic criterion
Having IBS Symptoms according to ROME-IV diagnostic criterion
Having informed consent and ability of participation in study and adherence to gluten free diet
Being at least 18 years old
Exclusion criteria:
Having inflammatory, infectious or organic gastrointestinal disease
Having coeliac disease
Having Cirrhosis
Using corticosteroids, non steroidal anti-inflammatory drugs, or medications that are effective in gastrointestinal tract movement
Having thyroid disease
Pregnancy
Psychiatric conditions and inability to give informed consent
Being on gluten free diet before entering the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is simple randomization. the researcher will divide patients by using table of random numbers.
First, each patient will be assigned a two-digit code according to the date and time of the clinic visit. The first patient will have code 01 and the last patient will have code 44.
Then in the table of random numbers without looking, a location will be randomly selected. The first two digits will be examined. If the number is less than or equal to 44, it will be selected, otherwise we will continue moving in the direction of the line and other numbers will be checked. If it is a duplicate number, it will be ignored and another number from the table will be checked.
We continue this process until 22 codes are selected. The first 22 codes will be for patients in the intervention group (patients who will receive a gluten-free diet) and the remaining 22 codes will be for the control group (patients who will receive a normal diet). Thus, patients are randomly divided into two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences; Resalat boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.UMSU.REC.1398.348
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
Abdominal Distention or Flatulence
Timepoint
Before intervention and after 4 weeks
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Abdominal pain
Timepoint
Before intervention and after 4 weeks
Method of measurement
Visual Analogue Scale (VAS)
3
Description
Constipation
Timepoint
Before intervention and after 4 weeks
Method of measurement
Visual Analogue Scale (VAS)
4
Description
Diarrhea
Timepoint
Before intervention and after 4 weeks
Method of measurement
Visual Analogue Scale (VAS)
5
Description
Nausea and or vomiting
Timepoint
Before intervention and after 4 weeks
Method of measurement
Visual Analogue Scale (VAS)
6
Description
Disease effect on daily life
Timepoint
Before intervention and after 4 weeks
Method of measurement
Visual Analogue Scale (VAS)
7
Description
Mental well being
Timepoint
Before intervention and after 4 weeks
Method of measurement
Visual Analogue Scale (VAS)
8
Description
Fecal urgency
Timepoint
Before intervention and after 4 weeks
Method of measurement
According to patient history
9
Description
Incomplete defecation sense
Timepoint
Before intervention and after 4 weeks
Method of measurement
According to patient history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Gluten free group. in this group necessary education about gluten free diet and foods that patients must avoid including wheat, barley and rye will be provided. At the beginning demographic information and symptoms will be documented. after 4 weeks patients will be reevaluated.
Category
Treatment - Other
2
Description
Control group: Normal Diet group. This group of patients will continue their normal diet with out any further intervention At the beginning demographic information and symptoms will be documented. after 4 weeks patients will be reevaluated.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Reza Pashaee
Street address
Imam Khomeini Hospital; Ershad boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3398 1002
Email
pashaee.m@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences; Resalat boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
i.mohebbi@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Reza Pashaee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital; Ershad boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Email
pashaee.m@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Reza Pashaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital; Ershad boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3198 8001
Fax
Email
pashaee.m@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Reza Pashaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital; Ershad boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3198 8001
Fax
Email
pashaee.m@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information provided.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available