Actively Recruiting
Whole Genome Association Study to Identify Genetic Factors Predicting Success of Combined Mediterranean and Low-FODMAP Dietary Intervention for Irritable Bowel Syndrome Symptoms
Led by Attikon Hospital · Updated on 2025-04-06
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating genetic factors that may influence how patients with Irritable Bowel Syndrome (IBS) respond to a special combined diet which includes a Mediterranean diet and a low-FODMAP diet. This study focuses on identifying single nucleotide polymorphisms (SNPs) linked to positive or negative diet responses. IBS is a common chronic digestive disorder affected by many factors including genetics, and this study aims to understand the genetic role in dietary treatment success. Participants will follow a three-phase dietary intervention starting with an elimination phase on the Med-LFD diet for 2 to 6 weeks. This is followed by a gradual reintroduction of foods high in FODMAPs over 6 to 8 weeks to test personal tolerance, and finally a maintenance phase where an individualized diet is tailored based on that tolerance. Blood and stool samples will be collected before and after the intervention for DNA and gut microbiota analysis. Throughout the study, symptom severity will be measured using the IBS-SSS scale, and mental health assessed with the Hospital Anxiety and Depression Scale (HADS). Researchers will also evaluate quality of life, symptom burden, and changes in gut microbiota from baseline through about one year of follow-up. Participants will be asked to commit to availability during the study period, and the main outcome is finding genetic markers linked to diet response.
CONDITIONS
Brief Title
GWAS to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of IBS Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fulfillment of the Rome IV criteria for IBS
- Provision of written informed consent
- Commitment to be available throughout the study period
- IBS Symptom Severity Score (IBS-SSS) greater than 175
- Age between 18 and 65 years
You will not qualify if you...
- Any disease requiring specialized nutrition such as renal failure, diabetes, celiac disease, cerebrovascular disease, or major surgical cavity
- Pregnancy
- Breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 to 20 weeks
Participants follow a combined Mediterranean and low-FODMAP diet to manage IBS symptoms. This includes an elimination phase, a reintroduction phase to test food tolerance, and a maintenance phase with an individualized diet based on personal tolerance.
Visits at baseline and periodic visits during diet phases
Duration - Up to 1 year
Participants are observed for up to 1 year to assess symptom changes, gut microbiota composition, quality of life, and mental health status after the dietary intervention.
Periodic follow-up visits throughout the year
Trial Site Locations
Total: 1 location
1
Attikon General University Hospital of Athens
Athens, Greece, 12462
Actively Recruiting
Research Team
K
Konstantinos Triantafyllou, Proffesor
M
Maroulla Nikolaki, PhD (c)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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