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

IBS - Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306381
• Other study ID #: IBS-2017
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: December 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome

Intervention

Other:
• Dietary intervention
Elimination of certain products.

Locations

Country	Name	City	State
Sweden	Deartment of INternal Medicine	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings	Changes from baseline in subjective symptoms according to the IBS-SSS.	4 weeks
Secondary	Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings	Changes from baseline in subjective symptoms according to the VAS-IBS.	4 weeks
Secondary	Gut microbiota composition	Changes from baseline in fecal microbiota analysed by 16rs	4 weeks
Secondary	Cytokines	Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.	4 weeks
Secondary	microRNA expression	Changes from baseline in microRNA expression will be assessed.	4 weeks