The ICON Study: Outcomes After FMT for Patients With IBD and CDI

NCT03106844 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2017P000386
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.

Conditions

Inflammatory Bowel Diseases; Clostridium Difficile Infection

Keywords

FMT; IBD

Outcome Measures

Primary Outcomes (1)

• Number of Participants With FMT Failure

  Recurrence of c.diffile infection

  8 weeks

Secondary Outcomes (1)

• Participants Colonized With C.Difficile

  8 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

All patients in this study will receive Fecal Microbiota Tranplantation

Drug: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation DRUG

Patients with at least 2 episodes of CDI and IBD will undergo a single FMT

Also known as: FMT

Treatment

Eligibility Criteria

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

You may qualify if:

• Adults age 18 or greater
• Confirmed recurrent CDI by positive PCR or EIA toxin test defined at ≥ 2 episodes and vancomycin failure within one year with the most recent being within the past 3 months.
• Confirmed diagnosis of IBD with colonic involvement (ulcerative colitis, Crohn's colitis or ileocolitis or indeterminate colitis) for ≥ 3 months
• Undergoing FMT via colonoscopy for CDI as part of standard medical care

You may not qualify if:

• Unable or unwilling to undergo a colonoscopy
• Inpatient status
• Anticipated immediate or upcoming surgery within 30 days
• Need for continued non-anti-CDI antibiotic therapy
• History of total or subtotal proctocolectomy
• Isolated ileal or small bowel disease
• Pregnancy or lactation
• Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months.
• Patients who are unable to give informed consent
• Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
• Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
• Life expectancy \< 6 months
• Unable to adhere to protocol requirements
• Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT
• Known concurrent HIV, Hepatitis B or C infection

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Indiana University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• The Miriam Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Jessica Allegretti MD MPH
• Organization: Brigham and Women's Hospital

jallegretti@bwh.harvard.edu

617-525-7322

Study Officials

• Jessica R Allegretti, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: August 1, 2017
• Primary Completion: April 7, 2020
• Study Completion: December 31, 2020
• Last Updated: February 10, 2021
• Results First Posted: September 21, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)