Comparison Between Low FODMAP and SSRD in IBS
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: low FODMAP or SSRD.
- Кому может быть актуально
- Состояния в реестре: IBS - Irritable Bowel Syndrome. Базовые параметры: 18 лет — 70 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
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison in the Effects and Mechanisms Between Low Fermentable-, Oligo-, di-, and Monosaccharides and Polyols (FODMAP) and Starch- and Sucrose-reduced Diet (SSRD) in Irritable Bowel Syndrome (IBS)
Обзор
The aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets.
Подробное описание
The investigator will perform a study on 200 subjects with verified irritable bowel syndrome (IBS). Participants will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study, participants will complete protocols concerning Rom IV criteria (to validate that the IBS criteria are ful-filled) as well as IBS symptom rating scales irritable bowel syndrome-symptoms severity scores (IBS-SSS) and visual analog scale for irritable bowel syndrome (VAS-IBS). The Item Health Survey 1.0 (distributed by RAND), RAND-36, includes the same items as those in the Short-Form Health Survey (SF-36), and evaluates the quality of Life. SCOFF is a brief questionnaire that asks the five questions about eating disturbances (Do you make yourself Sick because you feel uncomfortably full? Do you worry you have lost Control over how much you eat? Have you recently lost more than One stone in a 3 month period? Do you believe yourself to be Fat when others say you are too thin? Would you say that Food dominates your life?). Participants will be examined by an investigator who will complete protocols of clinical data. Blood and fecal samples will be collected by the investigator.
Study participants will thereafter be randomized to receive either low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=100), or a SSRD diet (starch ans sucrose-reduced diet) (n=100). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.
The participants are then free to eat whatever they want to, and another 5 months later, they will be examined again, the same protocols will be completed, and blood and fecal samples are collected.
The investigator will use samples from baseline, 4 weeks and 6 months, for genetic/epigenetic (including genomic-wide association studies), metabolomics, proteomics, nutritional data, gut microbiota, and inflammatory parameter analyses.
Statistics
The investigator will use Mann-Whitney U-test and Wilcoxon test to study differences in the above-mentioned parameters between the two treatment groups, as well as before and after dietary intervention, respectively. For analyses of genetic/epigenetics, metabolomics, proteomics, and microbiota, the investigator will use bioinformatics and biostatistics.
Вмешательства
- Пищевая добавка low FODMAP or SSRD
The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant
Первичные конечные точки
- Efficiency on bowel and extra-intestinal symptoms [Срок оценки: 4 weeks dietary intervention]
- Efficiency on bowel and extra-intestinal symptoms [Срок оценки: A follow-up 5 months after the end of the intervention]
- Efficiency on bowel symptoms [Срок оценки: 4 weeks dietary intervention]
- Efficiency on bowel symptoms [Срок оценки: A follow-up 5 months after the end of the intervention]
Вторичные конечные точки (12)
- Effects on plasminogen activator inhibitor-1 (PAI-1) [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on C-peptide [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on insulin [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on leptin [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on gastric inhibitory peptide (GIP) [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on visfatin [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on ghrelin [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on gut microbiota by whole genome sequencing of feces [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on microRNA [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on DNA methylation [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects depending on genetics [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
- Effects on vitamin A [Срок оценки: 4 weeks dietary intervention, with a follow-up after another 5 months]
Критерии участия
Критерии включения
- Verified IBS according to Rom IV criteria.
Критерии исключения
- Serious mental disease
- Serious somatic disease
- Abuse
- Inability to understand the Swedish language
- Already on a diet
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Швеция · 1 центр
- Deartment of INternal Medicine — Malmö
Публикации
- Roth B, Ohlsson B. Overweight and vitamin D deficiency are common in patients with irritable bowel syndrome - a cross-sectional study. BMC Gastroenterol. 2024 Sep 3;24(1):296. doi: 10.1186/s12876-024-03373-x. PMID 39227769
- Roth B, Ohlsson B. Challenges of recruitment processes to a randomized dietary trial in irritable bowel syndrome. F1000Res. 2024 Jun 24;13:323. doi: 10.12688/f1000research.147710.2. eCollection 2024. PMID 38939366
- Roth B, Ohlsson B. A starch- and sucrose-reduced diet may lead to improvement of intestinal and extraintestinal symptoms in more conditions than irritable bowel syndrome and congenital sucrase-isomaltase deficiency. Nutrition. 2024 Jan;117:112254. doi: 10.1016/j.nut.2023.112254. Epub 2023 Oct 8. PMID 37924624
Идентификаторы
NCT: NCT05192603 · IBS-2021