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Идёт набор NCT06912828

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Med-LFD intervention.
Кому может быть актуально
Состояния в реестре: Irritable Bowel Syndrome (IBS), Genome-wide Association Study, Single Nucleotide Polymorphisms, Mediterranean Diet. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Греция
Следующий шаг
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Официальное название

Whole Genome Association Study (GWAS) to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of Irritable Bowel Syndrome (IBS) Symptoms

Обзор

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).

Подробное описание

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.

Вмешательства

  • Другое Med-LFD 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 combinatio

Первичные конечные точки

  • Find single nucleotide polymorphisms (SNPs) that associate with the diet respone [Срок оценки: Baseline]
Вторичные конечные точки (5)
  • Change of symptoms severity pre and post intervention using a specialized questionnaire. [Срок оценки: Baseline and through study completion (an average of 1 year)]
  • Evaluation of the effect of interventions on gut microbiota composition between groups. [Срок оценки: Baseline and through study completion (an average of 1 year)]
  • Assessment of general quality of life pre and post intervention between groups [Срок оценки: Baseline and through study completion (an average of 1 year)]
  • Assessment of symptoms burden in general pre and post intervention. [Срок оценки: Baseline and through study completion (an average of 1 year)]
  • Assessment of anxiety and depression disorders pre and post intervention. [Срок оценки: Baseline and through study completion (an average of 1 year)]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Греция · 1 центр
  • Attikon General University Hospital of Athens — Athens

Идентификаторы

NCT: NCT06912828 · ΕΒΔ407/30.5.2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗