Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
200 participants
INTERVENTIONAL
2022-03-01
2029-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dietary intervention with Low FODMAP
The participants are given oral and written instructions on which diet that contains low contents of FODMAP.
low FODMAP or SSRD
The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant
Dietary intervention with SSRD
The participants are given oral and written instructions on which diet that contains SSRD.
low FODMAP or SSRD
The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant
Interventions
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low FODMAP or SSRD
The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Serious somatic disease
* Abuse
* Inability to understand the Swedish language
* Already on a diet
18 Years
70 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Bodil Ohlsson
Professor
Principal Investigators
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Bodil Ohlsson, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine
Bodil Roth, PhD
Role: STUDY_CHAIR
Department of Internal Medicine
Locations
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Deartment of INternal Medicine
Malmo, , Sweden
Countries
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References
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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.
Roth B, Ohlsson B. Challenges of recruitment processes to a randomized dietary trial in irritable bowel syndrome. F1000Res. 2024 Jun 24;13:323. doi: 10.12688/f1000research.147710.2. eCollection 2024.
Roth B, Ohlsson B. A starch- and sucrose-reduced diet may lead to improvement of intestinal and extraintestinal symptoms in more conditions than irritable bowel syndrome and congenital sucrase-isomaltase deficiency. Nutrition. 2024 Jan;117:112254. doi: 10.1016/j.nut.2023.112254. Epub 2023 Oct 8.
Other Identifiers
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IBS-2021
Identifier Type: -
Identifier Source: org_study_id
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