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Comparison Between Low FODMAP and SSRD in IBS

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)

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05192603
Enrollment
200
Registered
2022-01-14
Start date
2022-03-01
Completion date
2029-03-31
Last updated
2025-12-09

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, low FODMAP, SSRD

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.

Interventions

DIETARY_SUPPLEMENTlow FODMAP or SSRD

The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized, open study for dietary intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficiency on bowel and extra-intestinal symptoms4 weeks dietary interventionTo assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of irritable bowel syndrome-symptom severity score (IBS-SSS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel symptoms4 weeks dietary interventionTo assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.

Secondary

MeasureTime frameDescription
Effects on insulin4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze insulin by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on leptin4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze leptin by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on gastric inhibitory peptide (GIP)4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze GIP by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on visfatin4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze visfatin by mesoscale to see and compare the effects of the two different diets.
Effects on ghrelin4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze ghrelin by mesoscale to see and compare the effects of the two different diets.
Effects on gut microbiota by whole genome sequencing of feces4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze fecal microbiota by whole genome sequencing to see and compare the effects of the two different diets
Effects on microRNA4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze microRNA to see and compare the effects of the two different diets
Effects on DNA methylation4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze DNA methylation to see and compare the effects of the two different diets
Effects depending on genetics4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze sucrase-isomaltase (SI) genes to see if the genetic profile hais of importance for the clinical effect of the two diets
Effects on vitamin A4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze values of vitamin A in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on plasminogen activator inhibitor-1 (PAI-1)4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze plasminogen activator inhibitor-1 (PAI-1) by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on vitamin C4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze values of vitamin C in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on vitamin D4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze values of vitamin D in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on phosphorous4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze values of phosphorous in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on zinc4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze values of zinc in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on magnesium4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze values of magnesium in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on albumin4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze values of albumin in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on metabolomics and proteomics4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze metabolomics and proteomics in blood to see and compare the effects of the two different diets
Effects on quality of life by RAND-36 (comprehensive short-form generic profile for health-related quality of life (HRQoL))4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze how the two different diets influence quality of life, measured by RAND-36, to compare the effects of the two different diets. RAND-36 is comprised of 36 items on 5-point Likert scale, the higher score the better quality of life, that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Effects on eating disturbances4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze how the two different diets influence eating disturbances measured by SCOFF, to compare the effects of the two different diets. SCOFF contains 5 questions answered by yes or no: 1) Do you make yourself Sick because you feel uncomfortably full?, 2) Do you worry that you have lost Control over how much you eat?, 3)Have you recently lost more than One stone (14 lb) in a 3-month period?, 4)Do you believe yourself to be Fat when others say you are too thin?, and 5) Would you say that Food dominates your life?
Effects on healthcare consumption4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze how the two different diets influence healthcare consumption by asking the participants about how many times they have visited a Healthcare giver before, during and after the study, to compare the effects of the two different diets
Effects on vitamin B4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze values of vitamin B in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on C-peptide4 weeks dietary intervention, with a follow-up after another 5 monthsThe investigator will analyze C-peptide by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026