Trial Outcomes & Findings for Early FMT for C.Difficile (NCT NCT02465463)

Participants were recruited June 2015 through November 2016.

Early FMT for C.Difficile

Clinical remission rate is defined as the number of participants with an absence of clinical symptoms and/or negative C.difficile stool PCR.

A serious adverse event is any adverse experience that results in any of the following outcomes: * Death; * Life-threatening experience (adverse event is considered "life-threatening" if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death); * Requires inpatient hospitalization or prolongation of existing hospitalization; * Results in persistent or significant disability or incapacity; * Is a congenital anomaly or birth defect; * Is considered to be an important medical event (that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed in the definition above).

The Shannon Diversity Index is a quantitative measure that reflects how many different types (such as species) there are in a dataset (a community). 16s ribosomal gene sequencing and metabolomic profile of the gut microbiota were analyzed for both groups using the Shannon Diversity index (H). The greater the index, the more diverse a species.

SF-36: consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

The HADS is a fourteen item scale and each item on the questionnaire is scored from 0-3, from 0 = best and 3 = worst. A score can range between 0 and 21 for either anxiety or depression. Higher scores represent greater depressive/anxious symptoms.

Total cost was calculated as a summation of costs of medications, procedures, and fecal transplant used to treat C.difficile for each individual patient. A mean was calculated for both groups.