GWAS to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of IBS Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Med-LFD intervention.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome (IBS), Genome-wide Association Study, Single Nucleotide Polymorphisms, Mediterranean Diet. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Whole Genome Association Study (GWAS) to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of Irritable Bowel Syndrome (IBS) Symptoms
Overview
This is a GWAS that aims to identify possible single nucleotide polymorphisms (SNPs) that are associated with the response in a combined dietary pattern low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols and Meditteranean diet (MED-LFD) in a small group of patients with Irritable Bowel Syndrome (IBS).
Detailed description
Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Several factors seem to contribute to its development, such as psychological stress, intestinal dysbiosis, infections, post-traumatic syndrome and genetic predisposition. Regarding the nutritional management of IBS, there are several approaches to alleviate symptoms, such as the low-fructose diet low in fermentable oligosaccharides, disaccharides, monosaccharides and FODMAP polyols (LFD), recommendations from the British Institute of Health and Care Excellence (NICE) and the recently proposed combination of the Mediterranean diet and LFD (MED-LFD) proposed by our Research Group. However, genetic background expressed in single nucleotide polymorphisms (SNPs) appears to influence the response to even dietary interventions.
The aim of this GWAS is to identify SNPs that are associated with the negative or positive response to the diet.
At the baseline, blood samples will be collected for DNA extraction. Genotyping will be based on Next Generation Sequencing (NGS) technology to detect genetic factors associated with the effectiveness of the intervention. Symptom severity will be measured by the IBS-SSS scale. Mental health status will be assessed with the HADS (Hospital Anxiety and Depression Scale) questionnaire.
Patients will be recruited by the Department of Clinical Nutrition, Attikon University General Hospital, where the nutritional intervention will be carried out.
Interventions
- Other Med-LFD intervention
In the beginning of the intervention, blood and stool samples will be collected. All participants of the group at phase 1 (elimination phase), will initially follow the Med- LFD (2-6 weeks). At phase 2 (reintroduction phase), patients will gradually reintroduce foods rich in FODMAPs (6-8 weeks) and test their tolerance. At phase 3 (maintenance phase), following the reintroduction of foods rich in FODMAPs, patients will follow an individualized diet based on their personal tolerance (a combinatio
Primary outcome measures
- Find single nucleotide polymorphisms (SNPs) that associate with the diet respone [Time frame: Baseline]
Secondary outcome measures (5)
- Change of symptoms severity pre and post intervention using a specialized questionnaire. [Time frame: Baseline and through study completion (an average of 1 year)]
- Evaluation of the effect of interventions on gut microbiota composition between groups. [Time frame: Baseline and through study completion (an average of 1 year)]
- Assessment of general quality of life pre and post intervention between groups [Time frame: Baseline and through study completion (an average of 1 year)]
- Assessment of symptoms burden in general pre and post intervention. [Time frame: Baseline and through study completion (an average of 1 year)]
- Assessment of anxiety and depression disorders pre and post intervention. [Time frame: Baseline and through study completion (an average of 1 year)]
Eligibility criteria
Inclusion criteria
- Fulfillment of the Rome IV criteria for IBS
- Provision of written informed consent.
- Commitment of availability throughout the study period.
- IBS-SSS > 175
Exclusion criteria
- Any concomitant disease requiring specialized nutrition (e.g. renal failure, diabetes, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity).
- Pregnancy.
- Breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Greece · 1 center
- Attikon General University Hospital of Athens — Athens
Identifiers
NCT: NCT06912828 · ΕΒΔ407/30.5.2024