1. Home
  2. Approved trials
  3. » فارسی

Low FODMAPs diet vs. general dietary advice improves clinical response in patients with IBS-D: a randomized controlled trial

Protocol summary

Summary
This study is designed to investigate the effect of low FODMAP diet vs. current dietary treatment, general dietary advices, on the clinical response and quality of life in patients with diarrhea subtype of IBS (IBS-D), and will be performed as a randomized (Blocked randomization), single blind trial at one medical center in Kerman, Iran; the studied groups include a group taking the low FODMAP diet and another group taking general dietary advices, each of which consisting of 55 IBS-D patients, based on the ROM-III criteria. none of the patients was not aware about types of intervention. Inclusion criteria including: IBS with diarrhea subtype (Bristol Stool Form Scale ≥ 5) and age 20-60 years old. exclusion criteria including: having a confounder medical condition such as celiac disease, inflammatory bowel disease (IBD) or presence of cardiovascular, liver, kidney, neurologic diseases, diabetes and thyroid disorders, consumption of ω-3 FAs and other nutritional supplements in the last 3 months, pregnancy in during the study. The use of effective drugs against IBS such as drugs affecting GI motility is not allowed Gastrointestinal symptoms and bowel habit status will be evaluated using a symptom severity scoring system (IBS-SSS) and Bristol stool form scale (BSFS) pre and post intervention. the duration of intervention will be 6 weeks. Primary outcomes for this study is gastrointestinal symptoms severity and bowel habit status and secondary outcome is quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017093033308N1
Registration date: 2017-10-09, 1396/07/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-09, 1396/07/17
Registrant information
Name
Vahideh behrouz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 0380
Email address
vh.behrouz@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Low FODMAPs diet vs. general dietary advice improves clinical response in patients with IBS-D: a randomized controlled trial
Public title
Low FODMAPs diet in patients with IBS-D
Purpose
Treatment
Inclusion/Exclusion criteria
. Inclusion criteria for participants' enrollment were IBS with diarrhea subtype (Bristol Stool Form Scale ≥ 5) and age 20-60 years old. Exclusion criteria were having a confounder medical condition such as celiac disease, inflammatory bowel disease (IBD) or presence of cardiovascular, liver, kidney, neurologic diseases, diabetes and thyroid disorders, consumption of ω-3 FAs and other nutritional supplements in the last 3 months, pregnancy in during the study. The use of effective drugs against IBS such as drugs affecting GI motility was not allowed, but antidepressants drugs were allowed on a stable dose for the last 3 months before inclusion.
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: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients will stratified according to age, sex and gastrointestinal symptoms severity

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe of Kerman University of Medical Sciences
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman,Iran
City
Kerman
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.KMU.REC.1395.98

Health conditions studied

1

Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhoea

Primary outcomes

1

Description
gastrointestinal symptoms
Timepoint
3 weeks
Method of measurement
questionnaire

2

Description
bowel habit status
Timepoint
6 weeks
Method of measurement
questionnaire

Secondary outcomes

1

Description
quality of life
Timepoint
6 weeks
Method of measurement
questionnaire

Intervention groups

1

Description
Low FODMAP diet
Category
Treatment - Other

2

Description
general dietary advices
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Dr. Zahedi Mohammad Javad
Street address
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research; Kerman University of Medical Sciences
Full name of responsible person
Pardakhti Abbas
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research; Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Vahideh Behrouz
Position
Ms.c. of nutrition
Other areas of specialty/work
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Postal code
Phone
+98 34 3251 0380
Fax
Email
vahideh.behrouz@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Vahideh Behrouz
Position
Ms.c. of nutrition
Other areas of specialty/work
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Postal code
Phone
+98 34 3251 0380
Fax
Email
vahideh.behrouz@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Vahideh Behrouz
Position
Ms.c. of nutrition
Other areas of specialty/work
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman,Iran
City
Kerman
Postal code
Phone
+98 34 3251 0380
Fax
+98 34 3251 0380
Email
vahideh.behrouz@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...