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Oral, frozen fecal microbiota transplant (FMT) capsules for recurrent Clostridium difficile infection

View Article: PubMed Central - PubMed

ABSTRACT

Background: Fecal microbiota transplantation (FMT) has been shown to be safe and effective in treating refractory or relapsing C. difficile infection (CDI), but its use has been limited by practical barriers. We recently reported a small preliminary feasibility study using orally administered frozen fecal capsules. Following these early results, we now report our clinical experience in a large cohort with structured follow-up.

Methods: We prospectively followed a cohort of patients with recurrent or refractory CDI who were treated with frozen, encapsulated FMT at our institution. The primary endpoint was defined as clinical resolution whilst off antibiotics for CDI at 8 weeks after last capsule ingestion. Safety was defined as any FMT-related adverse event grade 2 or above.

Results: Overall, 180 patients aged 7–95 years with a minimal follow-up of 8 weeks were included in the analysis. CDI resolved in 82 % of patients after a single treatment, rising to a 91 % cure rate with two treatments. Three adverse events Grade 2 or above, deemed related or possibly related to FMT, were observed.

Conclusions: We confirm the effectiveness and safety of oral administration of frozen encapsulated fecal material, prepared from unrelated donors, in treating recurrent CDI. Randomized studies and FMT registries are still needed to ascertain long-term safety.

No MeSH data available.


Related in: MedlinePlus

Cure rates and cumulative adverse events in 180 capsule fecal microbiota transplant recipients. All recipients were followed for 8 weeks, and 154 completed 6 months of follow-up 
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Fig1: Cure rates and cumulative adverse events in 180 capsule fecal microbiota transplant recipients. All recipients were followed for 8 weeks, and 154 completed 6 months of follow-up 

Mentions: From July 2013 through April 2016, 180 patients aged 7–95 years (median 64) were treated using fecal material collected from seven donors; 82 recipients were over 65 years old, whereas five were < 18 years and 15 were > 85 years. Cure rates and adverse events (to 6 months) are shown in Fig. 1. Of the 180 patients reaching 8 weeks, 147 were cured of CDI after the first administration of fecal capsules (82 %). Twenty six individuals relapsed within 8 weeks and were re-treated, with 17 responding, resulting in an overall cure rate of 91 % with one or two treatments. Six individuals declined re-treatment (our standard procedure in these cases is to offer long-term suppressive oral vancomycin treatment). Three patients were cured after a third administration, but were considered “non-responders” as per protocol definition. One patient received three treatments, relapsed, and was advised to continue suppressive vancomycin.Fig. 1


Oral, frozen fecal microbiota transplant (FMT) capsules for recurrent Clostridium difficile infection
Cure rates and cumulative adverse events in 180 capsule fecal microbiota transplant recipients. All recipients were followed for 8 weeks, and 154 completed 6 months of follow-up 
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5016994&req=5

Fig1: Cure rates and cumulative adverse events in 180 capsule fecal microbiota transplant recipients. All recipients were followed for 8 weeks, and 154 completed 6 months of follow-up 
Mentions: From July 2013 through April 2016, 180 patients aged 7–95 years (median 64) were treated using fecal material collected from seven donors; 82 recipients were over 65 years old, whereas five were < 18 years and 15 were > 85 years. Cure rates and adverse events (to 6 months) are shown in Fig. 1. Of the 180 patients reaching 8 weeks, 147 were cured of CDI after the first administration of fecal capsules (82 %). Twenty six individuals relapsed within 8 weeks and were re-treated, with 17 responding, resulting in an overall cure rate of 91 % with one or two treatments. Six individuals declined re-treatment (our standard procedure in these cases is to offer long-term suppressive oral vancomycin treatment). Three patients were cured after a third administration, but were considered “non-responders” as per protocol definition. One patient received three treatments, relapsed, and was advised to continue suppressive vancomycin.Fig. 1

View Article: PubMed Central - PubMed

ABSTRACT

Background: Fecal microbiota transplantation (FMT) has been shown to be safe and effective in treating refractory or relapsing C. difficile infection (CDI), but its use has been limited by practical barriers. We recently reported a small preliminary feasibility study using orally administered frozen fecal capsules. Following these early results, we now report our clinical experience in a large cohort with structured follow-up.

Methods: We prospectively followed a cohort of patients with recurrent or refractory CDI who were treated with frozen, encapsulated FMT at our institution. The primary endpoint was defined as clinical resolution whilst off antibiotics for CDI at 8&nbsp;weeks after last capsule ingestion. Safety was defined as any FMT-related adverse event grade 2 or above.

Results: Overall, 180 patients aged 7&ndash;95 years with a minimal follow-up of 8&nbsp;weeks were included in the analysis. CDI resolved in 82&nbsp;% of patients after a single treatment, rising to a 91&nbsp;% cure rate with two treatments. Three adverse events Grade 2 or above, deemed related or possibly related to FMT, were observed.

Conclusions: We confirm the effectiveness and safety of oral administration of frozen encapsulated fecal material, prepared from unrelated donors, in treating recurrent CDI. Randomized studies and FMT registries are still needed to ascertain long-term safety.

No MeSH data available.


Related in: MedlinePlus