Fecal Transplantation in Patients With Colonic Diverticulitis: a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion of patients treated with antibiotics within 3 months following FMT comparing FMT and placebo.
研究概览
简要总结
The goal of this clinical trial is to investigate the safety and effect of fecal microbiome transplantation (FMT) in patients with a former episode of acute colonic diverticulitis. The main question[s] it aims to answer are:
- Is FMT in patients with a former episode of acute colonic diverticulitis a safe procedure without severe adverse events
- What is the impact of FMT on patient-reported outcomes and re-admission rate
Participants will be asked to:
- to ingest either 25-30 capsules with FMT or placebo capsules
- Fill-in GI-QLI questionnaire prior to treatment/placebo and 3 months post baseline
- Fill-in eating habit questionnaire
- deliver blood-and stool samples prior to treatment/placebo and 3 months post baseline
- In both the treatment and placebo group 5 patients will be offered sigmoideoscopy for mucosal biopsies if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects]
详细描述
Colon diverticulosis (CD) is a prevalent condition, and its global incidence appears to be rising due to the aging population and an increasing number of younger individuals affected. Symptoms may encompass abdominal pain, changes in bowel habits, and bloating. The prevailing hypothesis suggests that CD arises from chronic constipation, resulting in heightened intraluminal pressure, colonic muscular hypertrophy, and mucosal herniation. However, the etiology remains incompletely understood, involving complex interactions among genetic factors, gut microbiota, and diet. The path from CD to diverticulitis is believed to involve diverticular obstruction, alterations in the gut microbiome, local tissue ischemia, and micro-perforations. Recent studies provide evidence supporting the role of altered colonic microbiota in CD pathogenesis, showing compositional changes in the microbiome of inpatients with acute diverticulitis (AD) characterized by decreased diversity and abundance of commensal microbiota as compared to healthy controls.
Traditionally, diverticulitis has been treated with antibiotics due to its association with bacterial overgrowth in the large intestine. However, prolonged antibiotic therapy has led to complications, such as Clostridioides difficile infection (CDI). Currently, studies are exploring the clinical evidence supporting the use of antibiotics for uncomplicated diverticulitis.
Fecal microbiota transplantation (FMT) has emerged as a novel therapeutic approach for recurrent CDI, involving the transfer of stool from healthy donors to the gastrointestinal tract of a recipient/patient. FMT is considered a safe and effective strategy to restore a healthy diversity of the gastrointestinal microbiota in patients with CDI. Furthermore, systematic reviews have demonstrated positive responses of FMT in managing inflammatory bowel disease (IBD), showcasing local therapeutic immune-modulating abilities.
Typically, patients with AD present with acute pain, tenderness in the left lower quadrant, fever, and elevated infection parameters. AD severity is categorized as uncomplicated diverticulitis or complicated diverticulitis, using the Hinchey classification. In Denmark, the diagnosis of diverticulitis is confirmed with a CT scan during acute hospitalization. While optical colonoscopy (OC) is rarely used for diagnostic purposes in the clinical setting due to the risk of complications, patients are offered a follow-up OC after conservative AD treatment, typically six weeks after inflammation resolution, to exclude malignancy.
Purpose The investigators aim to evaluate clinical and patient-reported efficacy, safety, and impact on the colonic microbiome of one FMT or one placebo-FMT administered via capsules in patients with diverticulitis.
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
- Double (Participant, Investigator)
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
- •CT-confirmed Acute Uncomplicated Diverticulitis: Eligible patients should have a confirmed diagnosis of acute uncomplicated diverticulitis based on in-hospital CT scans.
- •The condition must be defined as an infection limited to the colon, not extending to the peritoneum, and the patients should not require antibiotics treatment for their diverticulitis.
- •This definition ensures that the study focuses on cases of uncomplicated diverticulitis.
- •Admission to Odense University Hospital (Odense/Svendborg): Participants must be admitted to Odense University Hospital in Odense or Svendborg for the diagnosis and initial management of acute uncomplicated diverticulitis
排除标准
- •Inability to provide Informed Consent: Patient who are unable to comprehend the study information and provide informed consent due to cognitive impairment, language barriers or any other reason will be excluded.
- •Cognitive or Physical Impairment: Patients with disabilities that hinder their ability to comply with the study procedures, either cognitively or physically, will be excluded.
- •Complicated Diverticulitis: patients with complicated diverticulitis, as defined by the presence of abscesses, fistulas, perforations, or other severe complications on the CT scan, will not be eligible for participation.
- •CT Findings Requiring Biopsy or Polyp Removal: Individuals with CT findings indicating the need for colonoscopy to perform biopsy (e.g., suspected cancer) or for polyp removal will not be eligible for the study.
- •Presence of Other Gastrointestinal Diseases: Patients with other gastrointestinal diseases, for such as IBD, will be excluded to maintain a homogeneous study population.
- •Immunocompromised Patients: Individuals with known immunodeficiency disorders or undergoing immunosuppressive thearapy will be excluded due to potential safety concerns associated with FMT.
- •Impaired Renal Function: Patients with impaired renal function may be more susceptible to potential risks or complications associated with experimental intervention, and their inclusions could confound the results or increase the likelihood of adverse evenets.
- •History of FMT: Patients with a previous history of FMT will be excluded rom the study to avoid any potential confounding factors.
- •Pregnant and Lactation: Pregnant or lactating individuals will not be included to ensure the safety of both the mother and the fetus/infant..
- •Allergies to Active Substances in the Trial: Patients with known allergies to the active substances administered in the trial will not be eligible for participation.
- •Participation in Other Clinical Trials: Individuals currently participating in other clinical trials involving investigational drugs or interventions will not be eligible to avoid potential interference with study outcomes
结局指标
主要结局
Proportion of patients treated with antibiotics within 3 months following FMT comparing FMT and placebo.
时间窗: 3 months
Patient safety monitored by a) number of re-admissions, and b) number of adverse events within 3 months of FMT.
时间窗: 3 months
次要结局
- Change from baseline to 3 months in the GI-QLI questionnaire(3 months)
- Change from baseline to 3 months in: fecal bacteria composition and metabolism(3 months)
研究者
Thomas Bjørsum-Meyer
Principal investigator
Odense University Hospital