Ulcerative Colitis Associated Pouchitis
Conditions
Keywords
ulcerative colitis, fecal microbiota transplantation
Brief summary
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
Interventions
BIOLOGICALbiologically active human fecal microbiota
instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy
PROCEDUREsigmoidoscopy
Sponsors
Virginia O. Shaffer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experienced Improvement of Pouchitis Symptoms | 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Favorable Microbiota Profile | 3 months | 16s ribosomal gene sequencing and metabolomic profile of the gut microbiota |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fecal Microbiota Transplant fecal microbiota transplant
biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy
sigmoidoscopy | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Fecal Microbiota Transplant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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).
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Transplant | Number of Patients Who Experienced Improvement of Pouchitis Symptoms | 2 Participants |
Secondary
Number of Patients With Favorable Microbiota Profile
16s ribosomal gene sequencing and metabolomic profile of the gut microbiota
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Transplant | Number of Patients With Favorable Microbiota Profile | 3 Participants |