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

NCT03268213 | Completed Early Phase 1 DMC

• 1 other identifier: 479696
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Clostridium Difficile Infection; Ulcerative Colitis; Indeterminate Colitis

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. Safety will be assessed as a report of no new medical condition after the transplant, Tolerability, as recorded by report of no serious adverse events after the transplant and Efficacy of the procedure will be recorded as improvement in clinical symptoms during any clinically indicated colonoscopies after the transplant as compared to before transplant C. Diff patients will have a negative C. diff test report after the transplant as an out come measure.

  9 years

Secondary Outcomes (7)

• 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.

  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.

  10 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.

  10 years

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

  10 years

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

  10 years

Study Arms (1)

Fecal microbial transplantation

EXPERIMENTAL

Treated with fecal microbial transplantation

Biological: Fecal Microbial Transplantation

Interventions

Fecal Microbial Transplantation BIOLOGICAL

Fecal microbial transplant is offered as treatment option to eligible patients. Donors selected by the patients will be screened by questionnaire and by blood and stool tests for potential transmissible pathogens. The stool filtrate will be administered in the ileum and/or cecum via colonoscopy

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:

• \. 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.
• b. At least two episodes of severe C. difficile infection (\>6 diarrheal stools/day requiring hospitalization and associated with significant morbidity).
• c. 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.
• d. Severe and/or fulminant C. difficile colitis (\> 6 diarrheal stools/day) with no response to standard therapy after 48 hours.

You may not qualify if:

• 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
• used a TNFα agonist within the past 2 weeks
• diagnosed with Bacteremia within the past 4 weeks
• For patients with ulcerative and indeterminate colitis only:
• Patient is 7 years of age or older.
• One of the following:
• a. 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.
• younger than 7 years old

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

• Mintz M, Khair S, Grewal S, LaComb JF, Park J, Channer B, Rajapakse R, Bucobo JC, Buscaglia JM, Monzur F, Chawla A, Yang J, Robertson CE, Frank DN, Li E. Longitudinal microbiome analysis of single donor fecal microbiota transplantation in patients with recurrent Clostridium difficile infection and/or ulcerative colitis. PLoS One. 2018 Jan 31;13(1):e0190997. doi: 10.1371/journal.pone.0190997. eCollection 2018.

  PMID: 29385143 RESULT

MeSH Terms

Conditions

Clostridium Infections; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Anupama Chawla, MD

  Stony Brook Medicine

  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

Model Details: FMT is offered as a treatment to eligible patients

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: August 31, 2017
• Study Start: November 1, 2013
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)