GWAS to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of IBS Symptoms

Last updated: March 29, 2025
Sponsor: Attikon Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Irritable Bowel Syndrome (Ibs)

Gastroparesis

Diabetes Prevention

Treatment

Med-LFD intervention

Clinical Study ID

NCT06912828
ΕΒΔ407/30.5.2024
  • Ages 18-65
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Med-LFD intervention
Phase:
Study Start date:
September 15, 2024
Estimated Completion Date:
February 15, 2027

Study 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.

Connect with a study center

  • Attikon General University Hospital of Athens

    Athens, 12462
    Greece

    Active - Recruiting

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