Amount of stool per transplant / administered to patients: 30 pills a day for one day. Intervention: Low dose FMT capsules (30 pills once). Diluent used to prepare: Not Number of patients: 10. stated. Donors were unrelated donors Female: male: Not stated. from universal stool bank Age (mean/median): Not stated. Diluent used to store if frozen: (OpenBiome). Stored at -80oC prior to use. Comparator: High dose FMT. Donors working in healthcare: capsules (30 pills daily on two Preparation methods: Capsules Treatment arm: Low No. consecutive days). physically stable for 30 days at dose FMT capsules (30 Minor GI adverse Number of patients: 9. 25oC using an emulsion-based pills once). Donor demographics: mean age events: None. Female: male: Not stated. production protocol. Overall cure rate: 70% 26, mean BMI 22.2. Age (mean/median): Not stated. (n=7/10). Allegretti et al, Minor non-GI Time from preparation to Gastroenterology Donor screening: Questionnaire - adverse events: Comorbidities: Not stated. transplant (fresh): Not stated. (abstract), as per OpenBiome protocol. None. Treatment arm: High 2016 CDI features:Not stated. Time period for storage (frozen): dose FMT capsules (30 Travel and antibiotic exclusion Serious adverse Not stated. pills daily on two period: As per OpenBiome events: None. CDI diagnosis confirmation: Not consecutive days). protocol. Deaths: None. stated. Route administered: All capsule – Overall cure rate: 77.8% as described above. (n=7/9). Screening bloods: As per Pre-FMT antibiotics: Not stated. OpenBiome protocol. Number of infusions: 30 tablets Total follow up period: 8 weeks. (over one day). Screening stools: As per OpenBiome protocol. Cochrane Collaboration risk of Bowel purgative: Not stated. bias assessment: uncertain risk of PPI: Not stated. bias. Antimotility: Not stated. Prokinetics: Not stated. Time before CDI treatment was stopped before FMT: Not stated.
Allegretti et al, Gastroenterology (abstract), 2016 Intervention: Low dose FMT capsules (30 pills once). Number of patients: 10. Female: male: Not stated. Age (mean/median): Not stated. Comparator: High dose FMT. capsules (30 pills daily on two consecutive days). Number of patients: 9. Female: male: Not stated. Age (mean/median): Not stated. Comorbidities: Not stated. CDI features:Not stated. CDI diagnosis confirmation: Not stated. Pre-FMT antibiotics: Not stated. Total follow up period: 8 weeks. Cochrane Collaboration risk of bias assessment: uncertain risk of bias. Donors were unrelated donors from universal stool bank (OpenBiome). Donors working in healthcare: No. Donor demographics: mean age 26, mean BMI 22.2. Donor screening: Questionnaire - as per OpenBiome protocol. Travel and antibiotic exclusion period: As per OpenBiome protocol. Screening bloods: As per OpenBiome protocol. Screening stools: As per OpenBiome protocol. Amount of stool per transplant / administered to patients: 30 pills a day for one day. Diluent used to prepare: Not stated. Diluent used to store if frozen: Stored at -80oC prior to use. Preparation methods: Capsules physically stable for 30 days at 25oC using an emulsion-based production protocol. Time from preparation to transplant (fresh): Not stated. Time period for storage (frozen): Not stated. Route administered: All capsule – as described above. Number of infusions: 30 tablets (over one day). Bowel purgative: Not stated. PPI: Not stated. Antimotility: Not stated. Prokinetics: Not stated. Time before CDI treatment was stopped before FMT: Not stated. Treatment arm: Low dose FMT capsules (30 pills once). Overall cure rate: 70% (n=7/10). Treatment arm: High dose FMT capsules (30 pills daily on two consecutive days). Overall cure rate: 77.8% (n=7/9). Minor GI adverse events: None. Minor non-GI adverse events: None. Serious adverse events: None. Deaths: None.
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