Ulcerative Colitis Associated Pouchitis Clinical Trial
Official title:
The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis
| Verified date | March 2019 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to test whether Fecal Microbiota Transplant (FMT) is a safe and
effective treatment for people who have Ulcerative Colitis and have had an ileal pouch
anastomosis.
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that may be caused by a
person's immune system responding in an unusual way to bacteria normally found in the gut.
Studies have shown that the gut bacteria in people with ulcerative colitis (UC) are different
from the gut bacteria in people without ulcerative colitis (UC). Often, people with
ulcerative colitis (UC) have fewer types of bacteria in their gut which can change the way
that person's immune system works.
This study is for people who have had a proctocolectomy with an ileal pouch anastomosis
(IPAA) to treat ulcerative colitis (UC). More than 50% of people who have had an IPAA will
develop a condition called pouchitis. Pouchitis is short or long-term inflammation of the
ileal pouch that was created in order to store waste from your intestines. Patients with
pouchitis are being asked to take part in this study.
Currently, antibiotics, probiotics and prebiotics are used to treat pouchitis. However, it
has been shown that probiotics are not very helpful once the patient stops taking them. In
addition, antibiotics may cause unfavorable side effects. Fecal microbiota transplantation
(FMT) is being studied as another form of treatment for patients with active pouchitis. Fecal
microbiota transplantation (FMT) or "stool transplant" involves receiving a single fecal
enema from someone who has volunteered to donate their stool.
There are two purposes of this research study:
1. To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for
patients with ulcerative colitis (UC) associated pouchitis
2. To study the changes within the bacteria in the gut in patients with pouchitis (before
and after study treatment) using stool, blood and urine samples
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | February 1, 2018 |
| Est. primary completion date | February 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - male or female - age 18 to 65 years - ulcerative colitis-associated pouchitis - patients of Emory Clinic and/or Emory University Hospital Exclusion Criteria: - Age <18 years or >65 years of age - Exposure to immunosuppressive therapy (defined as steroid, etanercept, or anti-tumor necrosis factor (TNF)agents) within 1 month prior to enrollment - Concomitant Clostridium difficile infection - Suspected Crohn's disease - Documented active infection of any kind - Patients on anti-coagulant therapy, with platelet count less than 50,000, significant anemia with hemoglobin less than 7 or those with other conditions that place them at increased risk of bleeding - Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection - Administration of investigational drug within one month prior to planned FMT - Pregnant or breastfeeding women |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory St. Joseph's Hospital | Atlanta | Georgia |
| United States | Emory University | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Virginia O. Shaffer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients Who Experienced Improvement of Pouchitis Symptoms | Improvement of clinical pouchitis symptoms based on the clinical component of the modified pouchitis disease activity index (mPDAI) without relapse. These components include: stool frequency (number of stools), rectal bleeding, fecal urgency or abdominal cramps, or fever (temperature >37.8C). | 3 months | |
| Secondary | Number of Patients With Favorable Microbiota Profile | 16s ribosomal gene sequencing and metabolomic profile of the gut microbiota | 3 months |