The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS
Primary Purpose
IBS - Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional basic science trial for IBS - Irritable Bowel Syndrome focused on measuring IBS, Epigenetics, Dietary intervention, Gut Microbiota, Inflammation, Genetics
Eligibility Criteria
Inclusion Criteria:
- Verified IBS according to Rom IV criteria.
Exclusion Criteria:
- Serious mental or somatic disease
- Abuse
- Inability to understand he Swedish language
- Already on a diet (e.g. vegan, FODMAP, gluten-free).
Sites / Locations
- Deartment of INternal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dietary intervention subject group
Control group
Arm Description
n=130. Participants on low FODMAP-similar diet during 4-week study period.
n=20. Participants on traditional IBS diet during 4-week study period.
Outcomes
Primary Outcome Measures
Genetic variation of enzymes regulating absorption of disaccharides
Genetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.
Secondary Outcome Measures
Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings
Changes from baseline in subjective symptoms according to the IBS-SSS.
Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings
Changes from baseline in subjective symptoms according to the VAS-IBS.
Gut microbiota composition
Changes from baseline in fecal microbiota analysed by 16rs
Cytokines
Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
microRNA expression
Changes from baseline in microRNA expression will be assessed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03306381
Brief Title
The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS
Official Title
The Effect of Dietary Intervention on Symptoms in Relation to Genetical Characteristics, Epigenetics, Gut Microbiota, and Autoantibodies in IBS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the present study is to research whether subjects with irritable bowel syndrome (IBS) display epigenetic/genetic changes or altered microbiota compared to a non-IBS control group. Further, we will investigate if these parameters as well as subjective IBS symptoms are affected by a 4-week long dietary intervention within the IBS patient group.
Detailed Description
The study will be performed on 140 subjects with verified IBS. Patients will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study patients will fill out protocols concerning Rom IV criteria (to validate that IBS criteria are filled) as well as IBS symptom rating scales. They will be examined by a physician/researcher who will complete protocols of clinical data. Blood and fecal samples will be collected. A control group of healthy, non-IBS individuals will go through the same procedure as described above.
Study participants with IBS will thereafter be randomized to receive an alternative diet resembling the FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=130), or to continue with their regular diet (control group; n=20). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.
Samples from baseline and 4 weeks will be used for genetic/epigenetic (including genomic-wide association studies), gut microbiota and inflammatory parameter analyses.
Statistics
To study differences in the above-mentioned parameters between patients and controls as well as before and after dietary intervention, Mann-Whitney U-test and Wilcoxon test will be used, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
Keywords
IBS, Epigenetics, Dietary intervention, Gut Microbiota, Inflammation, Genetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary intervention subject group
Arm Type
Experimental
Arm Description
n=130. Participants on low FODMAP-similar diet during 4-week study period.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
n=20. Participants on traditional IBS diet during 4-week study period.
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
Elimination of certain products.
Primary Outcome Measure Information:
Title
Genetic variation of enzymes regulating absorption of disaccharides
Description
Genetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.
Time Frame
measured at baseline
Secondary Outcome Measure Information:
Title
Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings
Description
Changes from baseline in subjective symptoms according to the IBS-SSS.
Time Frame
4 weeks
Title
Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings
Description
Changes from baseline in subjective symptoms according to the VAS-IBS.
Time Frame
4 weeks
Title
Gut microbiota composition
Description
Changes from baseline in fecal microbiota analysed by 16rs
Time Frame
4 weeks
Title
Cytokines
Description
Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
Time Frame
4 weeks
Title
microRNA expression
Description
Changes from baseline in microRNA expression will be assessed.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Verified IBS according to Rom IV criteria.
Exclusion Criteria:
Serious mental or somatic disease
Abuse
Inability to understand he Swedish language
Already on a diet (e.g. vegan, FODMAP, gluten-free).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil Ohlsson, MD, PhD
Organizational Affiliation
Region Skane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deartment of INternal Medicine
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35484927
Citation
Nilholm C, Manoharan L, Roth B, D'Amato M, Ohlsson B. A starch- and sucrose-reduced dietary intervention in irritable bowel syndrome patients produced a shift in gut microbiota composition along with changes in phylum, genus, and amplicon sequence variant abundances, without affecting the micro-RNA levels. United European Gastroenterol J. 2022 May;10(4):363-375. doi: 10.1002/ueg2.12227. Epub 2022 Apr 28.
Results Reference
derived
Learn more about this trial
The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS
We'll reach out to this number within 24 hrs