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临床试验/NCT05088434
NCT05088434已完成不适用

Comparison of the Fecal Microbiota Transplantation and ACHIM Suspension for Manipulating the Gut Microbiota in Patients With Irritable Bowel Syndrome

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Gut microbiota analysis

研究概览

简要总结

The double-blinded placebo-controlled study compares the effect of fecal microbiota transplantation vs. Anaerobically Cultivated Human Intestinal Microbiota (ACHIM) or placebo (own feces) on manipulating the gut microbiota in patients with diarrhea-predominant irritable bowel syndrome (IBS).

详细描述

Fecal transplantation (FMT), the infusion of a fecal preparation from a healthy donor into the gastrointestinal tract of another human being is capable of altering the gut microbiome of the new host. There is speculation that human faeces from a healthy donor may constitute the ideal "probiotic", thus suggesting FMT as a treatment option for conditions where an altered microbiota has been detected, including irritable bowel syndrome (IBS) . Anaerobically Cultivated Human Intestinal Microbiota (ACHIM) is an alternative way to manipulate gut microbiota instead of FMT. ACHIM suspension is a natural ecosystem of normal intestinal bacteria cultivated and propagated regularly in the laboratory (in vitro). After 20 years of cultivation ACHIM has retained the same rich biodiversity as the original stool sample, originating from a healthy donor in 1995. ACHIM can restore the ecological balance of the gut when it has been disturbed (dysbiosis) e.g. after antibiotic treatment. ACHIM has until now been given to over 400 patients (most of them suffering from recurrent Clostridium difficile infection) without any serious side effects being observed. Microbiological tests have shown that ACHIM is a well-balanced functional microbiota, and contains the major bacterial phyla Firmicutes, Bacteroidetes, Proteobacteria and Actinobacteria .

Thus, in the present study aims at comparing these methods safety and efficacy in relieving symptoms in patients with IBS. Given the ethical concerns of unknown and long-term adverse effects of FMT therapy, only patients with moderate to severe symptoms will be included.

Aim:

The primary aim of this open pilot study was to compare these two gut manipulating methods (FMT and ACHIM) in IBS patients.

The secondary aims were as follows;

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Double-blinded placebo-controlled study

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

  • Patients of age between 18-and 65 years.
  • Have IBS-Symptom Severity Scale (IBS-SSS) score >
  • All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or mixed constipation and diarrhoea (IBS-M) with bloating or flatulence as predominant symptoms.
  • All patients will undergo appropriate investigations to exclude organic disease.

排除标准

  • History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool
  • Antibiotic use within 1 month prior to FMT
  • Immunocompromised patient defined as taking immuno-suppressive medications
  • History of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
  • Patients who are scheduled for abdominal surgery.
  • Pregnant or lactating women.
  • Patients taking probiotics or taking antibiotics within 4 weeks prior to installation.
  • Inclusion criteria of donors for FMT:
  • Close healthy, family members
  • > 18 years old.
  • Exclusion criteria of donors for FMT:
  • Pregnancy or lactation
  • History of inflammatory bowel diseases, IBS, chronic abdominal pain, or gastrointestinal malignancy, diarrhea, blood in stool
  • Antibiotic and pre/probiotic use within 1 month prior to FMT.
  • Immunocompromised defined as taking immuno-suppressive medications
  • History of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.

结局指标

主要结局

Gut microbiota analysis

时间窗: 6 months

Change in bacterial signals from baseline before transplantation with either donor-FMT, ACHIM of placebo to after transplantation at weeks 1, 4, 12 and 24, by using the GA-map Dysbiosis Test (Genetic Analysis AS, Oslo, Norway). The GA-test is based comprising fecal sample homogenization and mechanical bacterial cell disruption; combined with chemical cell lysis; automated total bacterial genomic DNA extraction using magnetic beads; 16S rRNA PCR DNA amplification covering the variable regions V3-V9; probe labelling by single nucleotide extension; hybridisation to complementary probes coupled to magnetic beads; and signal detection using BioCode 1000A 128-Plex Analyzer (Applied BioCode, Santa Fe Springs, California, USA). A Dysbiosis Index (DI) above 2 (maximum 5) indicated microbiota that differs from the reference group (DI 1-2: non-dysbiosis, DI 3: moderate, DI 4-5: severe dysbiosis).

次要结局

  • Bristol stool form scale(6 months)
  • Short form of Nepean Dyspepsia Index (SF-NDI)(6 months)
  • Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)(6 months)
  • Hospital Anxiety and Depression Scale (HADS)(6 months)
  • Eysenck Personality Questionnaire Neuroticism (EPQ-N-12_(6 months)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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