Clinical trial NCT05192603: Comparison Between Low FODMAP and SSRD in IBS
Official title: Comparison in the Effects and Mechanisms Between Low Fermentable-, Oligo-, di-, and Monosaccharides and Polyols (FODMAP) and Starch- and Sucrose-reduced Diet (SSRD) in Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: IBS
low FODMAP
SSRD
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open study for dietary intervention
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets.

Detailed description: The investigator will perform a study on 200 subjects with verified irritable bowel syndrome (IBS). Participants will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study, participants will complete protocols concerning Rom IV criteria (to validate that the IBS criteria are ful-filled) as well as IBS symptom rating scales irritable bowel syndrome-symptoms severity scores (IBS-SSS) and visual analog scale for irritable bowel syndrome (VAS-IBS). The Item Health Survey 1.0 (distributed by RAND), RAND-36, includes the same items as those in the Short-Form Health Survey (SF-36), and evaluates the quality of Life. SCOFF is a brief questionnaire that asks the five questions about eating disturbances (Do you make yourself Sick because you feel uncomfortably full? Do you worry you have lost Control over how much you eat? Have you recently lost more than One stone in a 3 month period? Do you believe yourself to be Fat when others say you are too thin? Would you say that Food dominates your life?). Participants will be examined by an investigator who will complete protocols of clinical data. Blood and fecal samples will be collected by the investigator.

Study participants will thereafter be randomized to receive either low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=100), or a SSRD diet (starch ans sucrose-reduced diet) (n=100). 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.

The participants are then free to eat whatever they want to, and another 5 months later, they will be examined again, the same protocols will be completed, and blood and fecal samples are collected.

The investigator will use samples from baseline, 4 weeks and 6 months, for genetic/epigenetic (including genomic-wide association studies), metabolomics, proteomics, nutritional data, gut microbiota, and inflammatory parameter analyses.

Statistics

The investigator will use Mann-Whitney U-test and Wilcoxon test to study differences in the above-mentioned parameters between the two treatment groups, as well as before and after dietary intervention, respectively. For analyses of genetic/epigenetics, metabolomics, proteomics, and microbiota, the investigator will use bioinformatics and biostatistics.

Eligibility criteria: Inclusion Criteria:

* Verified IBS according to Rom IV criteria.

Exclusion Criteria:

* Serious mental disease
* Serious somatic disease
* Abuse
* Inability to understand the Swedish language
* Already on a diet

Primary outcomes:
measure: Efficiency on bowel and extra-intestinal symptoms
timeFrame: 4 weeks dietary intervention
measure: Efficiency on bowel and extra-intestinal symptoms
timeFrame: A follow-up 5 months after the end of the intervention
measure: Efficiency on bowel symptoms
timeFrame: 4 weeks dietary intervention
measure: Efficiency on bowel symptoms
timeFrame: A follow-up 5 months after the end of the intervention
Secondary outcomes:
measure: Effects on plasminogen activator inhibitor-1 (PAI-1)
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on C-peptide
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on insulin
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on leptin
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on gastric inhibitory peptide (GIP)
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on visfatin
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on ghrelin
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on gut microbiota by whole genome sequencing of feces
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on microRNA
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on DNA methylation
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects depending on genetics
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on vitamin A
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on vitamin B
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on vitamin C
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on vitamin D
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on phosphorous
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on zinc
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on magnesium
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on albumin
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on metabolomics and proteomics
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on quality of life by RAND-36 (comprehensive short-form generic profile for health-related quality of life (HRQoL))
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on eating disturbances
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
measure: Effects on healthcare consumption
timeFrame: 4 weeks dietary intervention, with a follow-up after another 5 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Deartment of INternal Medicine
Study officials:
affiliation: Department of Internal Medicine
name: Bodil Ohlsson, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine
name: Bodil Roth, PhD
role: STUDY_CHAIR
References: