CompletedPhase 1

Fecal Microbial Transplant (FMT) for Sjogrens Syndrome

United States10 participantsStarted 2019-04-15

Plain-language summary

This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Positive diagnosis of Sjogrens syndrome, defined by meeting two or more of the following three criteria:
✓. Age ≥ 18 years at time of enrollment
✓. Able to provide signed and dated informed consent
✓. Women of child childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment.
✓. Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception\*.

✕. Inability to provide informed consent and/or unable or unwilling to comply with protocol requirements.
✕. Antibiotics for at least 2 weeks prior to FMT.
✕. Active infection for \>15 days: bacteremia, urinary tract infection, pneumonia or abdominal collection.
✕. Known or suspected toxic megacolon and/or known small bowel ileus.
✕. Previous FMT
✕. Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
✕. History of total colectomy or bariatric surgery.
✕. Antibiotics for the treatment of an active infection or anticipated antibiotic use during trial duration.

Number of participants with reported adverse events (AEs) and serious adverse events (SAEs)

Timeframe: 7 months

Number of participants with stable microbiome engraftment

Timeframe: month 3

NCT IDNCT03926286

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Positive diagnosis of Sjogrens syndrome, defined by meeting two or more of the following three criteria:
✓. Age ≥ 18 years at time of enrollment
✓. Able to provide signed and dated informed consent
✓. Women of child childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment.
✓. Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception\*.

✕. Inability to provide informed consent and/or unable or unwilling to comply with protocol requirements.
✕. Antibiotics for at least 2 weeks prior to FMT.
✕. Active infection for \>15 days: bacteremia, urinary tract infection, pneumonia or abdominal collection.
✕. Known or suspected toxic megacolon and/or known small bowel ileus.
✕. Previous FMT
✕. Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
✕. History of total colectomy or bariatric surgery.
✕. Antibiotics for the treatment of an active infection or anticipated antibiotic use during trial duration.