Protocol summary

Study aim
To investigate and compare the efficacy of administration of gluten free diet on clinical symptoms and signs, quality of life, and inflammatory factors in patients with irritable bowel syndrome under low FODMAP diet
Design
Randomized Clinical Trial
Settings and conduct
In this study, patients with irritable bowel syndrome referring to Taleghani Hospital, if they wish to participate in the study informed consent of them will be taken. All patients undergo low FODMAP+strict gluten free diet after delivery of blood and stool samples for 6 weeks. In the second 6 weeks, they will be randomly assigned to one of the three intervention and control groups, and the blood and stool samples and scores will be evaluated for the evaluation of IBS symptoms.
Participants/Inclusion and exclusion criteria
1)18-65 years 2) Patients with irritable bowel syndrome, according to gastroenterologist diagnosed according to the ROME- IV criteria 3) lack of any organic intestinal disease(diagnosed by last 5 years ago colonoscopy) and intestinal infections(diagnosed by stool culture). 4) No medical history of chronic gastrointestinal and colorectal disease Absence of any major bowel surgery 5) Absence of regular use of laxatives or antidiarrheal drugs
Intervention groups
1) Group I: will receive food products with 8g/day gluten for first 2 weeks, 16g/day gluten for second 2 weeks, following 32g/day gluten for third 2 weeks. 2) Group II: will continue low FODMAP+ strict (Gluten free) diet for 6 weeks. 3) Control group: will receive free diet for 6 weeks.
Main outcome variables
Age, Sex, Smoking, Weight, Height, Body Mass Index(BMI), Total energy intake, Total carbohydrate intake, Total fat intake, Total protein intake, Total fiber intake, Total SFA intake, Total MUFA intake, Total PUFA intake, serum level of IL-6 and INF-ɣ

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100524004010N26
Registration date: 2018-10-20, 1397/07/28
Registration timing: registered_while_recruiting

Last update: 2018-10-20, 1397/07/28
Update count: 0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-22, 1396/06/31
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of gluten free diet on clinical symptoms and signs, quality of life, and inflammatory factors in patients with irritable bowel syndrome under low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet
Public title
Effect of gluten free diet in treatment of IBS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years Patients with irritable bowel syndrome, according to gastroenterologist diagnosed according to the ROME- IV criteria (1.Improvement with defecation 2.Onset associated with a change in stool frequency 3.Onset associated with a change in stool form (appearance) At least three days a month, three months a year and no pathological findings in the clinical investigating) lack of any organic intestinal disease(diagnosed by last 5 years ago colonoscopy) and intestinal infections(diagnosed by stool culture). No medical history of chronic gastrointestinal and colorectal disease Absence of any major bowel surgery Absence of regular use of laxatives or antidiarrheal drugs No chronic use of antibiotics, corticosteroids and immunosuppressants No usage of drugs that modifying the digestive motility such as metoclopramide, cisapride, diphenoxylate,… No usage of drugs that increased bleeding of intestinal mucosa such as aspirin, warfarin, heparin,… No history of breast cancer in patient or in first-degree relatives of a person Absence of severe mental or behavioral disorder Absence of nicotine and its derivatives use in last 6 months No usage of NSAIDs and aspirin in last week(influence on gut permeability)
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The method use in this study to create a randomization process is simple randomization, so we utilize random number table. Beginning of the study, each person is randomly assigned to one of the three study groups according to the randomized distribution table.
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 Shahid Beheshti University Of Medical Sciences
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2017-10-15, 1396/07/23
Ethics committee reference number
IR.SBMU.RIGLD.REC.1396.154

Health conditions studied

1

Description of health condition studied
Irritable Bowel Syndrom
ICD-10 code
k55-k64
ICD-10 code description
Other diseases of intestines

Primary outcomes

1

Description
Age
Timepoint
Beginning of study
Method of measurement
Question

2

Description
Gender
Timepoint
Beginning of study
Method of measurement
Observation

3

Description
Weight
Timepoint
Beginning and end of study
Method of measurement
Balance

4

Description
Height
Timepoint
Beginning and end of study
Method of measurement
Meter

5

Description
BMI
Timepoint
Beginning and end of study
Method of measurement
Calculation

Secondary outcomes

1

Description
Smoking
Timepoint
Beginning of study
Method of measurement
Question

2

Description
Type of diet
Timepoint
Beginning and end of study
Method of measurement
Data collection form

3

Description
Total Calorie Intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare

4

Description
Total Carbohydrate Intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare

5

Description
Total Protein Intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare

6

Description
Total Fat Intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare

7

Description
Total Fiber Intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare

8

Description
Total MUFA Intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare

9

Description
Total PUFA Intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare

10

Description
Total SFA Intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare

11

Description
IL-6
Timepoint
Begining and end of the study
Method of measurement
Enzymatic method using a kit

12

Description
INF-ɣ
Timepoint
Begining and end of the study
Method of measurement
Enzymatic method using a kit

Intervention groups

1

Description
Intervention group: 1) Group I: will receive food products with 8g/day gluten for first 2 weeks, 16g/day gluten for second 2 weeks, following 32g/day gluten for third 2 weeks.
Category
Treatment - Other

2

Description
Intervention group: 2) Group II: will continue low FODMAP+ strict (Gluten free) diet for 6 weeks.
Category
Treatment - Other

3

Description
Control group: will receive free diet for 6 weeks
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleqani Hospital
Full name of responsible person
Dr Mohammad Rostaminejad
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
taleghanihospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Afshin Zarghi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Azita Hekmatdoost
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hafezi Ave, Shahid Farahzadi Blvd, Shahrak Qarb
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2237 6480
Email
A_hekmat2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hafezi Ave, Shahid Farahzadi Blvd, Shahrak Qarb
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2237 6480
Email
A_hekmat2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeede Saadati
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd.,Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21224325609
Email
s.saadati1992@gmail.com

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
Because the participant’s informations should remain confidental.
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
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