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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAttikon Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Fulfillment of the Rome IV criteria for IBS

Provision of written informed consent.

Commitment of availability throughout the study period.

IBS-SSS > 175

Disqualifiers

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 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Med-LFD intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Basic group1 intervention

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

1

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

IBS- SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS) with total scores ranging from 0 to 500, with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (\>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.

Time frame
Baseline and through study completion (an average of 1 year)
2

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

Fecal samples will be collected from each participant and stored at -80°C.

Time frame
Baseline and through study completion (an average of 1 year)
3

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

12-Item Short Form Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective, covering the eight domains of health outcomes: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional \& mental health. The items are weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on the questions that range from 0 to 100, with higher score indicating better health.

Time frame
Baseline and through study completion (an average of 1 year)
4

Assessment of symptoms burden in general pre and post intervention.

The GSRS questionnaire was originally developed for dyspeptic patients but was later validated in patients with IBS. The GSRS is a 15-item questionnaire designed to assess common gastrointestinal symptoms. The questionnaire has five subscales, reflux, diarrhea, constipation, indigestion, and abdominal pain, with subscale scores ranging from 1 (no discomfort) to 7 (severe discomfort). Higher scores represent higher symptom burden.

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

Other outcomes

Sponsors and contacts

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