Fecal Microbial Transplantation in Patients With Crohn's Disease

NCT03267238 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 973349
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Fecal Microbiota Transplantation will be offered to eligible Crohn's disease patient as Investigational New Drug treatment

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

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

  Number of participants with treatment-related adverse events with grade greater than 2 within one year after FMT will be reported.

  5 years

Secondary Outcomes (6)

• 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.

  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.

  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.

  6 years

• To measure the effect of fecal microbial transplantation on microbial function using bacterial metatranscriptomic sequencing

  6 years

• To measure the effect of fecal microbial transplantation on microbial function using targeted metabolomic assays.

  6 years

Study Arms (1)

Fecal Microbial transplantation

EXPERIMENTAL

Fecal Microbial Transplantation will be offered to patients eligible to be part of the study.

Biological: Fecal Microbial Transplantation

Interventions

Fecal Microbial Transplantation BIOLOGICAL

Fecal Microbial Transplantation via will be offered to eligible Crohn's patient

Also known as: FMT

Fecal Microbial transplantation

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• has been treated with steroid therapy for at least a month
• has been treated with immunomodulatory therapy for at least a month
• 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

You may not qualify if:

• Patients less than 7 years of age
• Scheduled for abdominal surgery within the next 12 weeks
• Major abdominal surgery within the past 3 months
• Pregnancy (This will be checked through a urine test on the day of procedure)
• Anemia: Hemoglobin \< 6 g/dL,
• 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
• A known diagnosis of graft vs. host disease
• Presence of an intra-abdominal or perianal abscess.
• Presence of intestinal cutaneous fistula
• Presence of severe intestinal stricture and/or intestinal obstruction
• Administration of any investigational drug within the past 2 months
• Use of a TNF-α antagonist within 2 weeks of the proposed date of transplantation
• Bacteremia within past 4 weeks (28 days)
• Severe Crohn's Disease, determined by Pediatric Crohns Disease Activity Index (PCDAI) value of more than 29.
• Individuals with severe prior allergic reaction to food;

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ellen Li, MD, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 30, 2017
• Study Start: June 16, 2017
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)