The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS
1 other identifier
interventional
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
October 11, 2017
CompletedStudy Start
First participant enrolled
January 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedDecember 10, 2019
December 1, 2019
1.1 years
September 18, 2017
December 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
measured at baseline
Secondary Outcomes (5)
Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings
4 weeks
Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings
4 weeks
Gut microbiota composition
4 weeks
Cytokines
4 weeks
microRNA expression
4 weeks
Study Arms (2)
Dietary intervention subject group
EXPERIMENTALn=130. Participants on low FODMAP-similar diet during 4-week study period.
Control group
NO INTERVENTIONn=20. Participants on traditional IBS diet during 4-week study period.
Interventions
Eligibility Criteria
You may qualify if:
- Verified IBS according to Rom IV criteria.
You may not qualify if:
- Serious mental or somatic disease
- Abuse
- Inability to understand he Swedish language
- Already on a diet (e.g. vegan, FODMAP, gluten-free).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Deartment of INternal Medicine
Malmo, 20502, Sweden
Related Publications (2)
Roth B, Ohlsson B. Overweight and vitamin D deficiency are common in patients with irritable bowel syndrome - a cross-sectional study. BMC Gastroenterol. 2024 Sep 3;24(1):296. doi: 10.1186/s12876-024-03373-x.
PMID: 39227769DERIVEDNilholm 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.
PMID: 35484927DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bodil Ohlsson, MD, PhD
Region Skane
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2017
First Posted
October 11, 2017
Study Start
January 15, 2018
Primary Completion
February 28, 2019
Study Completion
February 28, 2019
Last Updated
December 10, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share