The study aimed to investigate the effect of a low Fermentable Oligo-, Di-, and Mono-saccharydes and Polyols (FODMAP) diet on intestinal microbium and inflammation in patients with Ulcerative colitis.
Design
Hospital based controlled randomized clinical trial
Settings and conduct
Sampling will be done at Shariati hospital in Tehran, using available sampling method and based on inclusion criteria. Participants will be randomly stratified into binary blocks in terms of age, gender, body mass index, and drug type. Individuals in the intervention group will receive a low-FODMAP diet for 4 weeks. Participants in the control group will receive their usual diet without any modification, along with the specific recommendations, for 4 weeks.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1. Age over than 20 and under 60 years
2. Moderate ulcerative colitis
3. BMI 18.5 to 30 kg/m2
Patients with the following properties will not be included:
1. Changed in the type or dosage of their drugs over the past month
2. Suffered from other gastrointestinal diseases including cancers and infectious diseases
3. Pregnant or breastfeeding women or those with a decision for pregnancy in the near future
4. Use of antibiotics
5. Consumed pre- or pro-biotic products during the last two months
6. Use tobacco or smoke
7. Hospitalized in the last three months
8. Infection over the past 3 months
9. Suffering from any inflammation-promoting disease
9. Used multi-vitamin and mineral supplements during the past month
Intervention groups
Individuals in the intervention group will receive a low-FODMAP diet based their usual dietary intakes consistent with the specific recommendations of IBD patients.
Individuals in the control group will receive their usual diet along with IBD specific recommendations.
Main outcome variables
Gut micribium, Serum inflammatory cytokines
General information
Reason for update
Acronym
FODMAP
IRCT registration information
IRCT registration number:IRCT20181126041763N1
Registration date:2019-01-18, 1397/10/28
Registration timing:prospective
Last update:2019-01-18, 1397/10/28
Update count:0
Registration date
2019-01-18, 1397/10/28
Registrant information
Name
Alireza Milajerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5805
Email address
amkhv@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fermentable carbohydrates restricted diet on gut microbium and some inflammatory indices in patients with ulcerative colitis
Public title
Effect of flatulent carbohydrates restricted diet on gut microbium and inflammation in patients with ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over than 20 and under 60 years
Moderate ulcerative colitis (ulcerative colitis diagnosis will be done by a gastroenterologist, using the Mayo score) who are on stable drug therapy. The scores of 6-8 will be considered as moderate UC.
BMI 18.5 to 30 kg/m2
Exclusion criteria:
Changed in the type or dosage of their drugs over the past month
Suffered from other gastrointestinal diseases including cancers and infectious diseases
Pregnant or breastfeeding women or those with a decision for pregnancy in the near future
Use of antibiotics
Consumed pre- or pro-biotic products during the last two months
Use tobacco or smoke
Hospitalized in the last three months
Infection over the past 3 months
Suffering from any inflammation-promoting condition
Used multi-vitamin and mineral supplements during the past month
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
participants will be matched in terms of age (20 to 40 and 40 to 60 years), gender (male/female), body mass index (18.5 to 24.9 and 25 to 30) and drug type (anti-inflammatory (steroidal/anti-TNF) and immunosuppressant) in blocks composed of two patients in each blocks. Then, participants in each block will be randomly allocated to intervention or control groups. In order to randomize assignment of participants, each person will be given a specific code. Then, a person outside the study will be asked to draw the code out of a pot using the lottery. Participant with the first draw out code will be allocated to the intervention group, and the second code as the control; in order the rest of participants will be randomly assigned to the two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
School of nutritional sciences and dietetics, Hojatdoost Ave., Naderi street, Keshavarz blv, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.TUMS.VCR.REC.1397.441
Health conditions studied
1
Description of health condition studied
Inflammatory Bowel Disease (Ulcerative Colitis)
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Gut microbiota
Timepoint
Before Intervention and 4 weeks later
Method of measurement
PCR Method
Secondary outcomes
1
Description
Inflammation
Timepoint
Before intervention and 4 weeks later
Method of measurement
ELISA kit
Intervention groups
1
Description
Intervention group: Low-FODMAP diet in addition to general recommendations for IBD patients. Firstly, the basal metabolic rate (BMR) of the patients will be calculated using their age, sex, height and weight by the Harris Benedict formula. Then, daily energy requirement of each individual is calculated based on his/her physical activity when considering the thermogenic effect of foods (TEF). The macronutrient composition of this diet includes 55% energy from carbohydrates, 25% from fats, and 20% from proteins. Then, required values from each food group will be calculated. In each food group, food items with high FODMAP will be discarded, and the remaining foods will be divided into 6 meals/day, including 3 main meals and 3 snacks. Accordingly, a two-week meal menu will be set up that patients will continue it for two additional weeks (a total of 4 weeks).
Category
Treatment - Other
2
Description
Control group: General recommendations for patients with IBD including recommendations to have physical activity, timely disposing of feces, consumption of low-fat dairies and meats, consumption of vegetable oils, and reduction in consumption of refined sugars
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Alireza Milajerdi
Street address
Shariati Hospital, Jalal Ale Ahmad Street, Karegar Shomali street, Tehran
City
Tehran
Province
Tehran
Postal code
1411711335
Phone
+98 21 84901
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Esmaillzadeh
Street address
Enghlab Street
City
Tehran
Province
Tehran
Postal code
14155-6559
Phone
+98 21 8889 6696
Email
admin@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Milajerdi
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Enghelab street
City
Tehran
Province
Tehran
Postal code
14155-6559
Phone
+98 21 8889 6696
Email
amkhv@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Esmaillzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and dietetics, Hojatdoost Ave., Naderi street, Keshavarz Blv, Tehran
City
Tehran
Province
Tehran
Postal code
14155-6559
Phone
+98 21 8895 5805
Email
a.esmaillzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Milajerdi
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of nutritional sciences and dietetics, Hojatdoost street, Naderi street, Keshavarz Blv., Tehran
City
Tehran
Province
Tehran
Postal code
14155-6559
Phone
+98 21 8895 5805
Email
amkhv@yahoo.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
No additional information are available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study protocol has been provided and will be published in a article.
When the data will become available and for how long
3 months after study begging
To whom data/document is available
Data will be available for all.
Under which criteria data/document could be used
For use in clinic or written a review article. For original studies, it will be permitted if they acknowledge our study personnel.
From where data/document is obtainable
Using Email, by author who are responsible for updating data
What processes are involved for a request to access data/document
After receiving application by the author who are responsible for updating data and following consultation with scientific consultant, data will be provided .