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The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS

The Effect of Dietary Intervention on Symptoms in Relation to Genetical Characteristics, Epigenetics, Gut Microbiota, and Autoantibodies in IBS Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03306381
Enrollment
105
Registered
2017-10-11
Start date
2018-01-15
Completion date
2019-02-28
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS - Irritable Bowel Syndrome

Keywords

IBS, Epigenetics, Dietary intervention, Gut Microbiota, Inflammation, Genetics

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.

Interventions

OTHERDietary intervention

Elimination of certain products.

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Genetic variation of enzymes regulating absorption of disaccharidesmeasured at baselineGenetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.

Secondary

MeasureTime frameDescription
Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings4 weeksChanges from baseline in subjective symptoms according to the IBS-SSS.
Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings4 weeksChanges from baseline in subjective symptoms according to the VAS-IBS.
Gut microbiota composition4 weeksChanges from baseline in fecal microbiota analysed by 16rs
Cytokines4 weeksChanges from baseline in cytokine plasma concentrations will be assessed by ELISA.
microRNA expression4 weeksChanges from baseline in microRNA expression will be assessed.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026