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临床试验/NCT07481422
NCT07481422招募中1 期

Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome

University of Rijeka1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年3月15日最近更新:
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
70
试验地点
1
主要终点
Efficacy

研究概览

简要总结

The goal of this clinical trial is to learn if oral capsules containing lyophilized fecal microbiota transplantation (FMT) can safely and effectively treat refractory irritable bowel syndrome (IBS) in adults aged 18-65 years. The main questions it aims to answer are:

Does treatment with lyophilized FMT capsules reduce IBS symptom severity compared with placebo?

Does treatment with lyophilized FMT capsules improve quality of life, anxiety, and depression in patients with IBS?

Are there differences in the frequency of adverse events between participants receiving FMT capsules and those receiving placebo?

Researchers will compare lyophilized FMT capsules to placebo capsules to see if FMT reduces IBS symptoms and improves quality of life and mental health.

Participants will:

Be randomly assigned to receive either lyophilized FMT capsules or placebo capsules for three consecutive days.

Take the capsules under supervision after receiving a proton pump inhibitor before the first dose.

Complete questionnaires assessing symptom severity, quality of life, anxiety, and depression at baseline, 4 weeks, and 12 weeks after treatment.

Attend follow-up visits at 4 weeks and 12 weeks after treatment and receive a telephone follow-up call 10 days after capsule ingestion.

Report any adverse events and have vital signs and medical information monitored during follow-up.

This study will help determine whether oral lyophilized FMT capsules are a safe and effective treatment option for adults with refractory IBS.

详细描述

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder affecting approximately 7-21% of the population in Western countries. In Croatia, the estimated prevalence is up to 28%. IBS is a symptom-based condition with a chronic course that significantly affects quality of life, social functioning, and work productivity. It is characterized by disturbances in gastrointestinal motility, altered intestinal secretion, and visceral hypersensitivity in the absence of identifiable structural or biochemical abnormalities.

The exact etiology and pathophysiology of IBS remain incompletely understood. Current evidence suggests that IBS develops through a complex interaction of multiple mechanisms rather than a single underlying cause. These mechanisms include abnormal gastrointestinal motility, visceral hypersensitivity, low-grade intestinal inflammation, psychosocial factors, alterations in the brain-gut axis, and environmental influences. Increasing attention has been directed toward the role of intestinal microbiota, as changes in the composition and diversity of gut microorganisms have been observed in patients with IBS.

IBS symptoms vary widely between individuals and can significantly impair daily functioning and overall well-being. According to the Rome IV diagnostic criteria, IBS can be classified into four subtypes based on predominant bowel habits: diarrhea-predominant (IBS-D), constipation-predominant (IBS-C), mixed type (IBS-M), and unclassified IBS (IBS-U). Studies have demonstrated differences in intestinal microbiota composition between these subtypes, suggesting that microbial imbalance may contribute to the development and persistence of symptoms.

Management of IBS remains challenging. Current treatment strategies include dietary modifications, antidepressants, pro- and anti-motility drugs, serotonin receptor agonists and antagonists, antibiotics, and probiotics. However, these approaches often provide limited or temporary relief, and many patients continue to experience persistent symptoms despite treatment.

Considering the growing evidence that alterations in gut microbiota play an important role in IBS pathogenesis, fecal microbiota transplantation (FMT) has emerged as a potential therapeutic option for gastrointestinal disorders associated with dysbiosis. FMT involves the transfer of processed stool from a healthy donor to a recipient with the goal of restoring a balanced intestinal microbiota. The effectiveness of FMT has been well established in the treatment of recurrent Clostridioides difficile infection. However, the efficacy of FMT in IBS remains under investigation, with clinical trials producing mixed results. Some studies have reported improvements in IBS symptoms after FMT, while others have not demonstrated significant benefits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years of age
  • disease activity defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175
  • symptoms refractory to conservative medical therapy (hyoscine salts, osmotic laxatives such as polyethylene glycol, loperamide, rifaximin, tricyclic antidepressants, SSRIs or other antidepressants, peppermint oil)
  • negative evaluation for coeliac disease
  • signed informed consent

排除标准

  • pregnant or breastfeeding women
  • women of childbearing potential who are unwilling to use an acceptable method of birth control
  • severely immunocompromised or immunosuppressed (organ transplant recipients, those with neutropenia with an absolute neutrophil count of <500 cells per mm3, those receiving current treatment with antineoplastic drugs, HIV positive)
  • gastrointestinal symptoms explained by an alternative diagnosis (underlying IBD, infectious enteritis)
  • severe allergy to capsule components
  • therapy with new antidepressants or had a change in antidepressant dose within previous 3 months
  • serious medical comorbidities (including neurological or psychiatric comorbidities)
  • treatment with antibiotics 3 months before enrolment
  • previous history of FMT at any time in the past
  • unwillingness to ingest the capsules

研究组 & 干预措施

FMT

Experimental

Lyophilized FMT capsules

干预措施: FMT capsule (Other)

Placebo

Placebo Comparator

Placebo capsules

干预措施: Placebo (Other)

结局指标

主要结局

Efficacy

时间窗: 12 weeks

A decrease in the IBS-SSS of at least 50 points

次要结局

  • Qualty of life(12 weeks)
  • Hospital Anxiety and Depression Scale(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dora Palčevski

MD

University of Rijeka

研究点 (1)

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