Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Colitis, Infectious Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 4/3/2019 |
| Start Date: | November 2013 |
| End Date: | June 30, 2023 |
| Contact: | Anupama Chawla, MD |
| Email: | anupama.chawla@stonybrookmedicine.edu |
| Phone: | 6314448115 |
Fecal Microbial Transplantation in Patients With Medication Refractory Clostridium Difficile and/or Ulcerative Colitis or Indeterminate Colitis
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
require Investigational New Drug designation) and to eligible ulcerative colitis or
indeterminate colitis patients as Investigational New Drug treatment
The following hypothesis will be tested in this study:
1. Fecal microbiota transplantation is a safe, tolerable, and efficacious procedure for C.
difficile patients and is a safe and tolerable procedure for ulcerative colitis and
indeterminate colitis patients.
2. The fecal microbial diversity, composition and function in stool recipients after fecal
transplantation will change to a similar microbial diversity, composition and
functionality as found in donor stool.
Primary objectives:
1. To determine the short term safety and tolerability of fecal microbiota transplantation in
patients with recurrent or refractory Clostridium difficile and medication refractory
Ulcerative colitis or indeterminate colitis up to 12 weeks post-transplant.
Secondary objectives:
1a. To determine the long term safety and tolerability of fecal microbiota transplantation up
to 1 year post-transplant in patients with recurrent or refractory Clostridium difficile and
medication refractory Ulcerative colitis or indeterminate colitis.
1b. To determine the efficacy of fecal microbiota transplantation in patients with recurrent
or refractory Clostridium difficile defined as no recurrence of C. difficile within one year.
2. To compare microbial diversity in healthy donor stools compared to pre-FMT recipient
stools collected from patients (recipients) with recurrent or refractory Clostridium
difficile and medication refractory Ulcerative colitis or indeterminate colitis.
3. To compare microbial composition in healthy donor stools compared to pre-FMT recipient
stools from patients (recipients) with recurrent or refractory Clostridium difficile and
medication refractory Ulcerative colitis or indeterminate colitis.
4. To compare microbial function in healthy donor stools compared to pre-FMT recipient stools
from patients (recipients) with recurrent or refractory Clostridium difficile and medication
refractory Ulcerative colitis or indeterminate colitis.
5. To compare microbial diversity in healthy donor stools and pre-FMT recipient stools with 1
week post-transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
6. To compare microbial composition in healthy donor stools and pre-FMT recipient stools with
1 week post-transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
7. To compare microbial function in healthy donor stools and pre-FMT recipient stools with 1
week post-transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
8. To compare microbial diversity in healthy donor stools and pre-FMT recipient stools with
12 week post transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
9. To compare microbial composition in healthy donor stools and pre-FMT recipient stools with
12 week post transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
10. To compare microbial function in healthy donor stools and pre-FMT recipient stools with
12 week post transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
11. Stool calprotectin levels will be measured in the recipient at baseline pre-FMT, 1 week
and 12 weeks post FMT to determine if FMT causes a statistically significant change.
1. Fecal microbiota transplantation is a safe, tolerable, and efficacious procedure for C.
difficile patients and is a safe and tolerable procedure for ulcerative colitis and
indeterminate colitis patients.
2. The fecal microbial diversity, composition and function in stool recipients after fecal
transplantation will change to a similar microbial diversity, composition and
functionality as found in donor stool.
Primary objectives:
1. To determine the short term safety and tolerability of fecal microbiota transplantation in
patients with recurrent or refractory Clostridium difficile and medication refractory
Ulcerative colitis or indeterminate colitis up to 12 weeks post-transplant.
Secondary objectives:
1a. To determine the long term safety and tolerability of fecal microbiota transplantation up
to 1 year post-transplant in patients with recurrent or refractory Clostridium difficile and
medication refractory Ulcerative colitis or indeterminate colitis.
1b. To determine the efficacy of fecal microbiota transplantation in patients with recurrent
or refractory Clostridium difficile defined as no recurrence of C. difficile within one year.
2. To compare microbial diversity in healthy donor stools compared to pre-FMT recipient
stools collected from patients (recipients) with recurrent or refractory Clostridium
difficile and medication refractory Ulcerative colitis or indeterminate colitis.
3. To compare microbial composition in healthy donor stools compared to pre-FMT recipient
stools from patients (recipients) with recurrent or refractory Clostridium difficile and
medication refractory Ulcerative colitis or indeterminate colitis.
4. To compare microbial function in healthy donor stools compared to pre-FMT recipient stools
from patients (recipients) with recurrent or refractory Clostridium difficile and medication
refractory Ulcerative colitis or indeterminate colitis.
5. To compare microbial diversity in healthy donor stools and pre-FMT recipient stools with 1
week post-transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
6. To compare microbial composition in healthy donor stools and pre-FMT recipient stools with
1 week post-transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
7. To compare microbial function in healthy donor stools and pre-FMT recipient stools with 1
week post-transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
8. To compare microbial diversity in healthy donor stools and pre-FMT recipient stools with
12 week post transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
9. To compare microbial composition in healthy donor stools and pre-FMT recipient stools with
12 week post transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
10. To compare microbial function in healthy donor stools and pre-FMT recipient stools with
12 week post transplant recipient stool samples collected from patients (recipients) with
recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or
indeterminate colitis.
11. Stool calprotectin levels will be measured in the recipient at baseline pre-FMT, 1 week
and 12 weeks post FMT to determine if FMT causes a statistically significant change.
For C. difficile patients/recipients only:
Inclusion:
1. Patient is 7 years of age or older. 2. One of the following: 2a. At least two
recurrences (total three CDI infections) of mild to moderate C. difficile (<6 diarrheal
stools/day) diagnosed by positive toxin PCR or EIA after completing standard medical
therapy with metronidazole, vancomycin or fidaxomicin.
2b. At least two episodes of severe C. difficile infection (>6 diarrheal stools/day
requiring hospitalization and associated with significant morbidity).
2c. Moderate C. difficile infection (3-6 diarrheal stools/day not responding to successive
standard therapy, e.g. metronidazole, vancomycin and/or fidaxomicin) lasting at least 28
days.
2d. Severe and/or fulminant C. difficile colitis (> 6 diarrheal stools/day) with no
response to standard therapy after 48 hours.
Exclusion:
1. younger than 7 year old
2. scheduled for abdominal surgery within the next 12 weeks
3. had major abdominal surgery within the past 3 months
4. pregnancy
5. Hemoglobin < 6 g/dL
6. absolute neutrophil count less than 1500/mm3
7. known diagnosis of graft vs. host disease
8. used an investigational drug within the past 2 months
9. used a TNFα agonist within the past 2 weeks
10. diagnosed with Bacteremia within the past 4 weeks
For patients with ulcerative and indeterminate colitis only:
Inclusion:
1. Patient is 7 years of age or older.
2. One of the following:
2a. treated with steroid therapy for at least one month. 2b. treated with immunomodulatory
therapy for at least one month 2c. treated with biological therapy for at least one month.
Exclusion:
1. younger than 7 years old
2. scheduled for abdominal surgery within the next 12 weeks
3. had major abdominal surgery within the past 3 months
4. pregnancy
5. Hemoglobin < 6 g/dL
6. absolute neutrophil count less than 1500/mm3
7. known diagnosis of graft vs. host disease
8. used an investigational drug within the past 2 months
9. used a TNFα agonist within the past 2 weeks
10. diagnosed with Bacteremia within the past 4 weeks
11. previous FMT
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