Informed Ecological Rewiring of Gut Microbiome for Dysbiosis-associated Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Identification of microbial signatures discriminating PI-IBS from controls
研究概览
简要总结
Observational, multicenter, prospective study aimed at characterizing the gut microbiome in patients with post-infectious irritable bowel syndrome (PI-IBS) using whole genome sequencing (WGS). The study will compare microbiome composition and function between PI-IBS patients and two control groups (post-infectious subjects without irritable bowel syndrome -IBS- and healthy controls), with the goal of identifying reproducible microbial signatures and target taxa associated with disease and symptom severity.
详细描述
The human gut microbiome plays a key role in host physiology, including immune regulation, metabolism, and protection against pathogens. Alterations in microbiome composition (dysbiosis) have been associated with multiple diseases, including post-infectious irritable bowel syndrome (PI-IBS), a condition that develops after acute gastroenteritis and represents a well-defined model of microbiome disruption.
MicroRestore-1 is a national, multicenter, prospective observational study designed to characterize the gut microbiome of patients with PI-IBS and identify microbial signatures associated with the disease. The study represents Aim 1 of a broader research program investigating precision microbiome modulation strategies.
A total of 315 participants will be enrolled, including 105 PI-IBS patients, 105 post-infectious subjects without IBS, and 105 healthy controls. PI-IBS will be diagnosed according to Rome IV criteria. Eligible participants will undergo baseline clinical assessment, including symptom evaluation using the IBS Severity Scoring System (IBS-SSS), medical history, dietary habits, and lifestyle factors.
Stool samples will be collected at baseline and, for PI-IBS patients, at monthly follow-up visits for three months. Control subjects will provide a single sample at enrollment. All samples will be processed and stored under standardized conditions and analyzed centrally.
Microbiome analysis will be performed using whole genome shotgun sequencing, enabling high-resolution taxonomic and functional profiling. Bioinformatic and statistical analyses, including machine learning approaches, will be used to identify microbial signatures discriminating PI-IBS patients from controls and to explore associations between microbiome features and disease activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PI-IBS patients (n = 105)
- •Inclusion criteria
- •Age ≥ 18 years old
- •PI-IBS diagnosed according to Rome IV criteria (33).
- •Diagnosis no earlier than 3 months before enrollment.
- •Written informed consent and compliance with study procedures.
排除标准
- •Chronic organic gastrointestinal (GI) disorders (e.g. Inflammatory Bowel Disease -IBD), metabolic syndrome, obesity, diabetes, GI cancers, systemic autoimmune disorders.
- •History of major abdominal surgery.
- •Control cohort #1 - Post-infectious non-IBS (n = 105)
- •Inclusion criteria
- •Age ≥ 18 years old
- •History of acute infectious gastroenteritis >6 months before enrollment.
- •Complete recovery without persistent GI symptoms.
- •Exclusion criteria
- •Current or past diagnosis of IBS.
- •Any chronic GI or systemic disorders.
- •Control cohort #2 - Healthy subjects (n = 105)
- •Inclusion criteria
- •Age ≥ 18 years old
- •Healthy donors from FMT program or blood donor program.
- •No history of GI or systemic disorders.
- •Exclusion criteria
- •Any GI or systemic chronic condition.
- •Recent antibiotics/probiotics (<4 weeks).
- •Chronic medication affecting microbiome composition (e.g. PPI)
研究组 & 干预措施
Post-infectious-IBS patients
Patients diagnosed with post-infectious irritable bowel syndrome (PI-IBS) according to Rome IV criteria. Participants must be ≥18 years old and diagnosed within 3 months prior to enrollment. Clinical data, including IBS severity scoring system (IBS-SSS), medical history, diet, and lifestyle factors will be collected. Stool samples will be collected at baseline and at monthly follow-up visits for 3 months.
Post-infectious non-IBS controls
Adults ≥18 years old with a history of acute infectious gastroenteritis occurring more than 6 months prior to enrollment, with complete recovery and no persistent gastrointestinal symptoms or diagnosis of IBS. One stool sample and associated clinical and lifestyle data will be collected at enrollment.
Healthy controls
Healthy adult subjects ≥18 years old with no history of gastrointestinal or systemic disorders, recruited from fecal microbiota transplantation (FMT) or blood donor programs. Participants must not have taken antibiotics or probiotics within 4 weeks prior to enrollment. One stool sample and associated demographic and lifestyle data will be collected at enrollment.
结局指标
主要结局
Identification of microbial signatures discriminating PI-IBS from controls
时间窗: Baseline up to 30 months (end of study)
Identification of reproducible gut microbiome signatures, including taxonomic and functional profiles, that discriminate patients with post-infectious irritable bowel syndrome (PI-IBS) from control groups using whole genome shotgun sequencing and machine learning approaches.
次要结局
- Association between microbiome features and disease severity(Baseline up to 30 months (end of study))
研究者
IANIRO GIANLUCA
Principal Investigator, MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS