Fecal Microbial Transplantation in Patients With Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 28 February 2022
• Main ID: NCT03267238
• Date of registration: 24/07/2017
• Prospective Registration: No
• Primary sponsor: Stony Brook University
• Public title: Fecal Microbial Transplantation in Patients With Crohn's Disease
• Scientific title: Fecal Microbial Transplantation in Patients With Crohn's Disease
• Date of first enrolment: June 16, 2017
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03267238
• 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: Ellen Li, MD, PhD
• Affiliation: Stony Brook University

Key inclusion & exclusion criteria

Inclusion Criteria for initial Fecal Microbial Transplant for Crohn's disease:

All patients age =7 years of age with established diagnosis of Crohn's disease made by a
primary gastroenterologist based on history, physical examination, laboratory/radiological
studies, and gastrointestinal histology, with one or more of the following criteria:

1. has been treated with steroid therapy for at least a month

2. has been treated with immunomodulatory therapy for at least a month

3. has been treated with biological therapy for at leaset a month

All patients or legal guardians of patients less than 18 years of age will have to give
consent. The consent form will outline that although fecal microbiota transplantation
appears safe based on past studies, a theoretical risk of transmission of an unrecognized
infectious agent or substance exists and could result in an unexpected disease. All
patients aged =7 and <18 years will have to give assent

Exclusion Criteria:

1. Patients less than 7 years of age

2. Scheduled for abdominal surgery within the next 12 weeks

3. Major abdominal surgery within the past 3 months

4. Pregnancy (This will be checked through a urine test on the day of procedure)

5. Anemia: Hemoglobin < 6 g/dL,

6. Neutropenia: Absolute Neutrophil Count <1500 Both of the above criteria will be
checked via screening test or blood test reports within one month prior to the
procedure

7. A known diagnosis of graft vs. host disease

8. Presence of an intra-abdominal or perianal abscess.

9. Presence of intestinal cutaneous fistula

10. Presence of severe intestinal stricture and/or intestinal obstruction

11. Administration of any investigational drug within the past 2 months

12. Use of a TNF-a antagonist within 2 weeks of the proposed date of transplantation

13. Bacteremia within past 4 weeks (28 days)

14. Severe Crohn's Disease, determined by Pediatric Crohns Disease Activity Index (PCDAI)
value of more than 29.

15. Individuals with severe prior allergic reaction to food;

16. Individuals with intercurrent illness including but not necessarily limited to:
febrile illness, decompensated liver cirrhosis, HIV/AIDS BMT within past 150 days,
malignancy, or other severe immunodeficiency.

17. Individuals at increased risk for complications of endoscopy or procedural sedation
(e.g., ASA classification IV and above).

18. Previous FMT



Age minimum: 7 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

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: 5 years]

Secondary Outcome(s)

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: 6 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: 6 years]

Determine if FMT causes a statistically significant change in recipient fecal calprotectin levels [Time Frame: 6 years]

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: 6 years]

To measure the effect of fecal microbial transplantation on microbial function using targeted metabolomic assays. [Time Frame: 6 years]

To measure the effect of fecal microbial transplantation on microbial function using bacterial metatranscriptomic sequencing [Time Frame: 6 years]

Secondary ID(s)

973349

Source(s) of Monetary Support

Please refer to primary and secondary sponsors