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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 March 2022
Main ID:  NCT03268213
Date of registration: 22/03/2016
Prospective Registration: No
Primary sponsor: Stony Brook University
Public title: Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis FMT
Scientific title: Fecal Microbial Transplantation in Patients With Medication Refractory Clostridium Difficile and/or Ulcerative Colitis or Indeterminate Colitis
Date of first enrolment: November 2013
Target sample size: 12
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03268213
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Early Phase 1
Countries of recruitment
United States
Contacts
Name:     Anupama Chawla, MD
Address: 
Telephone:
Email:
Affiliation:  Stony Brook Medicine
Key inclusion & exclusion criteria

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 TNFa 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 TNFa agonist within the past 2 weeks

10. diagnosed with Bacteremia within the past 4 weeks

11. previous FMT



Age minimum: 7 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Clostridium Difficile Infection
Indeterminate Colitis
Intervention(s)
Biological: Fecal Microbial Transplantation
Primary Outcome(s)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 9 years]
Secondary Outcome(s)
To measure the effect of fecal microbial transplantation on microbial function using shotgun DNA metagenomic in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools. [Time Frame: 10 years]
Determine if FMT causes a statistically significant change in recipient fecal calprotectin levels [Time Frame: 10 years]
To measure the effect of fecal microbial transplantation on microbial diversity in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools. [Time Frame: 10 years]
To measure the effect of fecal microbial transplantation on microbial composition in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools. [Time Frame: 10 years]
Determine number of C. difficile recipients who have recurrent C. difficile within a year after fecal microbial transplant [Time Frame: 10 years]
To measure the effect of fecal microbial transplantation on microbial function using bacterial metatranscriptomic sequencing [Time Frame: 10 years]
To measure the effect of fecal microbial transplantation on microbial function using targeted metabolomic assays. [Time Frame: 10 years]
Secondary ID(s)
479696
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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