Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Massachusetts General Hospital
Age
7–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with refractory, recurrent or relapsing C. difficile infection (CDI) defined as EITHER:
* At least three episodes of mild-to-moderate CDI
* At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity
* One protracted episode of CDI, defined as at least 3 weeks of ongoing Grade 3 severe symptoms of CDI despite standard antimicrobial therapy for CDI
* We expect that most, but not all, subjects will have tried and failed a taper of vancomycin.
Willingness to accept risk of unrelated donor stool
Age 7 and above. Seven is chosen as a lower limit based upon the legal age of assent. Based on the literature, most children aged 7 and above can be taught to swallow even large capsules through simple coaching techniques
Able to consent for self, or parental assent/child assent as age appropriate
You may not be if
Delayed gastric emptying syndrome
Known chronic aspiration
Swallowing dysfunction or oral-motor dyscoordination.
Inability or unwillingness to swallow multiple large capsules
Pregnant women
Patients with an acute illness unrelated to CDI or an acute exacerbation of underlying comorbid condition
Patients with comorbidities associated with increased risk of serious infection following bacterial translocation, including but not limited to:
* subjects on major immunosuppressive agents including high dose corticosteroids, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biologic agents, anti-TNF agents, and others; chemotherapeutic anti-neoplastic agents\*
* Patients with decompensated liver cirrhosis, advanced HIV/AIDS, recent bone marrow transplant, hypoglobulinemia or other cause of severe immunodeficiency\*
Patients with a history of significant allergy to foods not excluded from the donor diet
