ISRCTN34467677进行中（未招募）2 期
A prospective, randomised placebo controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32457083/ protocol (added 28/05/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 20/07/2020:
- •1. Adult patients (age 18 years or older at time of consent)
- •2. Current or previous patient at Guy’s and St Thomas’ NHS Foundation Trust
- •3. Ability to understand the purpose, potential benefits, and risks of the study and capable of giving informed consent. The participant must be able to provide written informed consent.
- •4. Documented gastrointestinal carriage of ESBL or CPE (stool sample) in the 21 days prior to consent.
- •5. Symptomatic infection with the same target organism of interest in the preceding 6 months
- •Previous participant inclusion criteria:
- •1. Adult patients (age >18 years at time of randomisation)
- •2. Current or previous patient at Guy’s and St Thomas’ NHS Foundation Trust
- •3. Ability to understand the purpose, potential benefits and risks of the study and capable of giving informed consent. The participant must be able to provide written informed consent
- •4. Documented gastrointestinal carriage of ESBL or CPE (rectal swab or stool sample) within 21 days of randomisation
- •5. Symptomatic infection with the same target organism of interest in the preceding 6 months
排除标准
- •Current participant exclusion criteria as of 20/07/2020:
- •1. Pregnancy or planned pregnancy. Urine testing will be performed at screening to rule out pregnancy
- •2. Breastfeeding
- •3. Severe or life-threatening food allergy
- •4. Allergy or other contraindication to omeprazole, IMP or placebo ingredients
- •5. Treatment with systemic antibiotic on the day prior to 1st IMP/placebo dosing to the end of the dosing period
- •6. Treatment with pre or probiotics in the 4 weeks prior to randomisation and for the duration of the study
- •7. Severe immunodeficiency
- •7.1. Systemic chemotherapy <30 days from baseline or planned chemotherapy within the upcoming 6 months
- •7.2. Known HIV infection with CD4 count <250 cells/uL
- •7.3. Known neutropenia with absolute neutrophils <1.0x109
- •7.4. Prolonged treatment with corticosteroids (equivalent to prednisone >60 mg daily for > 30 days) within 8 weeks of randomisation
- •8. Life expectancy <6 months
- •9. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication
- •10. Patients who have received another investigational drug or device within 4 months prior to randomisation
- •Previous participant exclusion criteria:
- •1. Pregnancy or planned pregnancy. Urine testing will be performed at screening to rule out pregnancy in females
- •2. Breastfeeding
- •3. Severe or life-threatening food allergy
- •4. Allergy or other contraindication to any of the study drugs (omeprazole 20 mg)
- •5. Treatment with systemic antibiotic on the day prior to 1st IMP/placebo dosing to the end of the dosing period
- •6. Treatment with pre or probiotics in the 4 weeks prior to randomisation and for the duration of the study
- •7. Severe immunodeficiency;
- •7.1. Systemic chemotherapy <30 days from baseline or planned chemotherapy within the upcoming 6 months
- •7.2. Known HIV infection with CD4 count <250 cells/uL
- •7.3. Known neutropenia with absolute neutrophils <1.0x109
- •7.4. Prolonged treatment with corticosteroids (equivalent to prednisone >60 mg daily for > 30 days) within 8 weeks of randomisation
- •8. Life expectancy <6 months
- •9. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication
- •10. Patients who have received another investigational drug or device within 30 days prior to randomisation
- •11. Any condition or circumstance, in the opinion of the investigator, that would compromise the safety of the patient or the quality of the study data
研究者
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