NCT02847481, A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

Medical records are a funny thing. I've been gathering a lot of my medical history from various doctors over the years to prepare for both of my enrollment into a clinical trial and trip to Southeast Asia. One of my prior doctors threw out my medical history that contained immunizations!

The ducks are in order for enrollment into the clinical trial. I've sent the coordinator my medical records and I've passed their preliminary review. The next steps are:

1. Blood tests  (for CBC with diff; BUN; Alk Phosphate; creatinine; ALT; AST; total bilirubin; HIV 1 & 2; Hepatitis A Antibody, IgM; Hepatitis B Core Antibody; Hepatitis B Surface Antigen; Hepatitis C Antibody)

The blood tests must be performed within 30 days of the first site visit. Working backwards, I plan to visit the clinical site (in Boston, MA) in February because flights are cheaper then. Unfortunately this clinical trial is not sponsored by a big biotech with lots of cash, but only by the Principal Investigator, who is a doctor at Beth Israel Deaconess Medical Center in Boston. So I will have to pay for the flight myself. If I visit in February, my blood work will be done in January.

2. First site visit

During the first site visit it's my understanding that they'll review everything and if acceptable into the clinical trial, they'll randomize me into a cohort or "arm."

There are 4 arms:

Arms	Assigned Interventions
Experimental: fecal microbiota transplantation fecal microbiota transplantation	Procedure: fecal microbiota transplantation fecal microbiota transplantation
Placebo Comparator: placebo fecal microbiota transplantation placebo fecal microbiota transplantation	Drug: placebo fecal microbiota transplantation placebo fecal microbiota transplantation
Experimental: FMT after antibiotic pretreatment v1 fecal microbiota transplantation after antibiotic pretreatment	Procedure: fecal microbiota transplantation fecal microbiota transplantation Procedure: FMT with antibiotic pre-treatment (v1) FMT with antibiotic pre-treatment (v1)
Experimental: FMT after antibiotic pretreatment v2 fecal microbiota transplantation after antibiotic pretreatment	Procedure: fecal microbiota transplantation fecal microbiota transplantation Procedure: FMT with antibiotic pre-treatment (v2) FMT with antibiotic pre-treatment (v2)

If I'm entered into the 1st or 2nd arm, I will not need to re-visit the site for a 2nd time. I can take the FMT medication (real poop pill or fake poop pill) immediately.

If I'm entered into the 2nd arm, well, that doesn't benefit me at all! What a waste of a flight.

My preference is actually the 3rd or 4th arm as I feel an antibiotic pretreatment would have the best result. These arms will take longer to complete as the antibiotic pretreatment takes about 1 week, and then the FMT is given (in the form of a poop pill).

Wish me luck!