Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03106844
Other study ID # 2017P000386
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2017
Est. completion date December 31, 2020

Study information

Verified date October 2020
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 31, 2020
Est. primary completion date April 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Concurrent PSC - Patients with WBC< 3.0 x109th/L at baseline - Patients with platelet count < 100 x109th/L - Patients with initial elevation of AST or ALT > 1.5 times above normal limit at baseline - Non - steroidal anti-inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month - Treatment with vancomycin or metronidazole for more then 60 days prior to enrollment

Study Design


Intervention

Drug:
Fecal Microbiota Transplantation
Patients with at least 2 episodes of CDI and IBD will undergo a single FMT

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Brigham and Women's Hospital Icahn School of Medicine at Mount Sinai, Indiana University, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With FMT Failure Recurrence of c.diffile infection 8 weeks
Secondary Participants Colonized With C.Difficile asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing 8 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Active, not recruiting NCT04990258 - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Enrolling by invitation NCT06015789 - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Recruiting NCT03282786 - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT04960826 - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT00721812 - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 Phase 1
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Recruiting NCT04991324 - Cholecalciferol Comedication in IBD - the 5C-study Phase 3
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting NCT05043818 - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A