Date of Award

2019

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

Laura Levy, DHSc, PA-C

Abstract

OBJECTIVE: The objective of this selective EBM review is to determine whether or not “is frozen fecal microbiota transplantation as effective as fresh fecal microbiota transplantation via colonoscopic versus nasogastric tube administration in treating adults with Clostridium difficile infection?”

STUDY DESIGN: Review of two randomized, controlled trials (RCTs) and one randomized, open-label, controlled pilot study published between 2014 and 2017. Each included study was published in a peer reviewed journal in English language.

DATA SOURCES: Two RCTs and one pilot study were researched via PubMed.

OUTCOMES MEASURED: Resolution of Clostridium difficile infection (CDI) was measured via written subject diaries of symptoms for adverse events, stool pattern and CDI episodes. Clinical resolution of diarrhea was measured via structural questionnaires and written subject diaries of discomfort, bowel movements and stool type using the Bristol Stool Chart, total number of bowel movements per 24-hour period, abdominal discomfort and intolerance to treatment, and weekly communication after the last fecal microbiota transplant.

RESULTS: The RCT by Lee, et al. showed a statistically significant resolution of diarrhea without relapse at 13 weeks and adverse events with frozen fecal microbiota transplantation (FMT) (P=0.01). The RCT by Jiang, et al. did not show a statistically significant resolution of CDI during the 5 months after transplant with frozen FMT versus fresh FMT (P=0.233). The pilot study by Youngster, et al. did not show a statistically significant clinical resolution of diarrhea without relapse after 8 weeks with nasogastric versus colonoscopic administration of frozen fecal microbiota (P=0.628).

CONCLUSION: The evidence to determine whether frozen FMT is as effective as fresh FMT administered via NGT versus colonoscopy in treating adults with CDI is conflicting. The RCT by Lee, et al. provided adequate evidence that frozen FMT is non-inferior to fresh FMT at inducing clinical resolution of diarrhea in CDI. However, the RCT by Jiang, et al. did not reach statistical significance, thus, further investigation is warranted to adequately determine the effectiveness of frozen FMT at treating CDI. The administration of frozen FMT via nasogastric tube also requires further investigation as Youngster, et al. demonstrated a lack of statistical significance compared to colonoscopic administration of frozen FMT.

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