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

NCT06912828 | Recruiting

• 1 other identifier: ΕΒΔ407/30.5.2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

diet response; nutrigenetics

Outcome Measures

Primary Outcomes (1)

• Find single nucleotide polymorphisms (SNPs) that associate with the diet respone

  Blood samples will be collected for DNA extraction. Genotyping be based on Next Generation Sequencing (NGS). Quality control (QC) filtering will be applied at individual-and variant-level using specialized software.

  Baseline

Secondary Outcomes (5)

• Change of symptoms severity pre and post intervention using a specialized questionnaire.

  Baseline and through study completion (an average of 1 year)

• Evaluation of the effect of interventions on gut microbiota composition between groups.

  Baseline and through study completion (an average of 1 year)

• Assessment of general quality of life pre and post intervention between groups

  Baseline and through study completion (an average of 1 year)

• Assessment of symptoms burden in general pre and post intervention.

  Baseline and through study completion (an average of 1 year)

• Assessment of anxiety and depression disorders pre and post intervention.

  Baseline and through study completion (an average of 1 year)

Study Arms (1)

Basic group

MED-LFD Diet for 2 - 6 weeks. After this period there will be a reintroduction phase protocol that will last 6 - 8 weeks.

Other: Med-LFD intervention

Interventions

Med-LFD intervention OTHER

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 combination of high and low FODMAPs). In the end of intervention, stool samples will be collected again.

Basic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18-65 years with IBS (fullfiling ROME IV criteria) who have IBS-SSS\>175. People with any concomitant disease requiring specialized nutrition, pregnant or lactating women will be excluded.

You may qualify if:

• Fulfillment of the Rome IV criteria for IBS
• Provision of written informed consent.
• Commitment of availability throughout the study period.
• IBS-SSS \> 175

You may not qualify if:

• 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.

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon General University Hospital of Athens

Athens, 12462, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Konstantinos Triantafyllou, Proffesor

CONTACT

+306977402690; ktriant@med.uoa.gr

Maroulla Nikolaki, PhD (c)

CONTACT

+30 6979376752; mnikolaki@med.uoa.gr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate - Head of Clinical Nutrition Department of Attikon Hospital

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: April 6, 2025
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)