Investigating the effect of wheat / gluten-free diet on gastrointestinal and non-gastrointestinal symptoms in children and adolescents with functional abdominal pain
Design
Randomized clinical trial Phase 1 on 60 patients with functional abdominal pain that divided into 2 groups by random numbers table
Settings and conduct
Children with functional abdominal pain based on Rome 4 criteria of 2 to 18 years old, in 1398-1399 enter the study .Randomly, they are divided into two groups. Control (initiation of gluten-containing diet intervention) and intervention group (initiation of gluten-free diet intervention). At the beginning and at the end of each intervention and at the end of the wash out phase , gastrointestinal and non-gastrointestinal symptoms are recorded by the researcher by checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children with functional abdominal pain according to the criteria of Roman four aged 12 to 18 years.
Non-entry Criteria:
Children with abdominal pain with organic causes.
Intervention groups
Children with functional abdominal pain between the ages of 12 and 18 are divided into two groups based on a table of random numbers.The case group is given a gluten-free diet for 3 weeks.Then 3 weeks of regular diet as a wash out period and then 3 weeks of gluten-containing diet.The control group is first given a gluten-free diet for 3 weeks, then a regular diet for 3 weeks, and then a gluten-free diet for 3 weeks.
Main outcome variables
abdominal pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043224N2
Registration date:2020-06-09, 1399/03/20
Registration timing:registered_while_recruiting
Last update:2020-06-09, 1399/03/20
Update count:0
Registration date
2020-06-09, 1399/03/20
Registrant information
Name
Peiman Nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6331
Email address
peiman.nasri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Non-Wheat gluten Diet in Chidren and Adolescents With Functional Abdominal Pain
Public title
Evaluation of Non-Wheat gluten Diet in Chidren and Adolescents With Functional Abdominal Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with functional abdominal pain according to the criteria of Rome 4 in the ages of 12 to 18 years, referred to the subspecialty gastroenterology clinics of Isfahan University of Medical Sciences with the conditions.. ......
Do not take steroids or nonsteroidal anti-inflammatory drugs or any other medication for 2 weeks before endoscopic examination
Patients who are not on medication(Do not take steroids / antacids / proton pump inhibitors / probiotics / nonsteroidal anti-inflammatory drugs / antidepressants and antipsychotics)
Patients who have not been on a gluten-free / gluten-free diet for the past 6 months
Lack of sensitivity to wheat
Absence of other organic diseases of the gastrointestinal tract (celiac disease, inflammatory bowel disease .......)
Absence of abdominal surgery (intestinal resection)
Absence of diseases, infectious / diabetes mellitus / systemic autoimmune / immunodeficiency / psychological disorders
No previous anaphylactic reaction attacks
Negative Anti endomysial Ab test
Exclusion criteria:
Children with abdominal pain with organic causes.
Age
From 12 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Each child with functional abdominal pain is placed in the intervention or control group using a random number table as soon as the doctor diagnoses it.In this way, the even members are in the intervention group and the odd members are in the control group.
This process continues until the sample size is complete.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Ethics committee of Isfahan University of Medical Sciences, Isfahan University of medical sciences, Hezarjarib Ave,
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2019-04-12, 1398/01/23
Ethics committee reference number
IR.MUI.MED.REC.1398.584
Health conditions studied
1
Description of health condition studied
Functional abdominal pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Functional abdominal pain
Timepoint
In both groups before the intervention and three weeks after the intervention and three weeks after the Wash out.
Method of measurement
Check list and questionaire
Secondary outcomes
1
Description
In each stage of filling out the checklist, "In addition to abdominal pain, variables of diarrhea, bloating, body pain, limb pain, anxiety, headache, and feeling unwell are also evaluated."
Timepoint
In both groups before the intervention and three weeks after the intervention and three weeks after Wash out.
Method of measurement
Checklist and questionnaire.
Intervention groups
1
Description
Intervention group: First, a gluten-free diet is given for 3 weeks. Then 3 weeks of regular diet as a wash out period and then 3 weeks of gluten-containing diet.
Category
Treatment - Other
2
Description
Control group: First, a gluten-free diet is given for 3 weeks, then a normal diet for 3 weeks, and then a gluten-free diet for 3 weeks.