The effect of gluten free diet on gastrointestinal symptoms of individuals with idiopathic dyspepsia who referred to the gastroenterology clinics of Imam Khomeini hospital complex and Dr.Shariati hospital in 2017-2018
In this study, patients suffering from dyspepsia resistant to treatment and there was no specific cause for them in initial check and celiac disease and allergic to wheat have been ruled out, non-celiac gluten sensitivity (NCGS) are considered. All of the patients underwent 6 weeks of gluten-free diet. Individuals that have no improvement in symptoms, will excluded from our study; but people who have had partial or complete remission, were randomly divided into two groups, as well as being gluten-free diet are for three consecutive weeks. In the first week, one group receive gluten contain muffin and the second group received gluten free muffin (as a placebo), and the recurrence dyspepsia are examined.
In the second week, both groups have any muffin. In the third week, the first group receive placebo and the second group give gluten contain muffin and evaluate for recurrence of dyspepsia. This study is a double-blind, conducted in this period (9 weeks), patients are required to follow a gluten-free diet.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031833112N1
Registration date:2017-04-22, 1396/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-22, 1396/02/02
Registrant information
Name
Mohammad Mahdi Fanaeian
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9853
Email address
mfanaeian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigators, Sahar and Kalleh Food production company
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of gluten free diet on gastrointestinal symptoms of individuals with idiopathic dyspepsia who referred to the gastroenterology clinics of Imam Khomeini hospital complex and Dr.Shariati hospital in 2017-2018
Public title
The effect of gluten free diet on gastrointestinal symptoms of individuals with idiopathic dyspepsia who referred to the gastroenterology clinics of Imam Khomeini hospital complex and Dr.Shariati hospital in 2017-2018
Purpose
Diagnostic
Inclusion/Exclusion criteria
In this study, patients aged 18 to 55 years old suffering from dyspepsia resistant to treatment and there was no specific cause for them in initial check and celiac disease and allergic to wheat have been ruled out, non-celiac gluten sensitivity (NCGS) are considered. All of the patients underwent 6 weeks of gluten-free diet. Individuals that have no improvement in symptoms, will excluded from our study.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1675
Health conditions studied
1
Description of health condition studied
Non celiac gluten sensitivity disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Rsolving of intestinal and extraintestinal symptoms
Timepoint
Before the study, at the end of first and third weeks
Method of measurement
Questionnaire of clinical symptoms according to numerical rating scale
Secondary outcomes
1
Description
Serum anti Anti gliadin IgG level, fecal calprotectin
Timepoint
Before the study, at the end of first and third weeks
Method of measurement
Blood tests (ELISA) and stool tests (ELISA)
Intervention groups
1
Description
Gluten free muffins will given to control group for one week.
Category
Treatment - Other
2
Description
Gluten contain muffin (contain about 8gr gluten daily or 160 gr muffin daily) will given to intervention group for one week