Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
administration orally
administration orally placebo
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.
Time frame: 10 months
Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
Time frame: 10 months
Number of Participants With an Increase in Flora Diversity in Fecal Samples
Time frame: 10 months
Changes in gut motility
Changes in gut motility will be determined using Smart Pill (if completed successfully pre and post treatment) measuring gut motility
Time frame: 6 months
Monitor subjects' health information
The SF-36 will be administered at enrollment, follow-up clinic visits at Week 13 and 9 month, and early termination visit. Rapid Eating Assessment for Patients (REAP) is to help quickly assess diet and physical activity of individuals. In addition, subjects will be asked to maintain a paper diary recording number of BM per day and type of each BM after enrollment. Information such as hospitalizations or mortality from any cause will be collected as part of the health outcomes assessment throughout this study.
Time frame: 10 months
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