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

A

Attikon University Hospital

Status

Enrolling

Conditions

Genome-wide Association Study
Single Nucleotide Polymorphisms
FODMAP Diet
Mediterranean Diet
Irritable Bowel Syndrome (IBS)

Treatments

Other: Med-LFD intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06912828
ΕΒΔ407/30.5.2024

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Basic group
Description:
MED-LFD Diet for 2 - 6 weeks. After this period there will be a reintroduction phase protocol that will last 6 - 8 weeks.
Treatment:
Other: Med-LFD intervention

Trial contacts and locations

1

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Central trial contact

Maroulla Nikolaki, PhD (c); Konstantinos Triantafyllou, Proffesor

Data sourced from clinicaltrials.gov

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