CompletedEarly Phase 1

Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis

United States12 participantsStarted 2013-11

Plain-language summary

Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis patients as Investigational New Drug treatment

Who can participate

Age range7 Years

SexALL

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Exclusion criteria

✕. younger than 7 year old
✕. scheduled for abdominal surgery within the next 12 weeks
✕. had major abdominal surgery within the past 3 months
✕. pregnancy
✕. Hemoglobin \< 6 g/dL
✕. absolute neutrophil count less than 1500/mm3
✕. known diagnosis of graft vs. host disease
✕. used an investigational drug within the past 2 months

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: 9 years

Trial details

NCT IDNCT03268213

SponsorStony Brook University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-15

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