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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fecal microbiota transplant | Experimental | fecal microbiota transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biologically active human fecal microbiota | Biological | instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Favorable Microbiota Profile | 16s ribosomal gene sequencing and metabolomic profile of the gut microbiota | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia O. Shaffer, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Emory St. Joseph's Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fecal Microbiota Transplant | fecal microbiota transplant biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy sigmoidoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fecal Microbiota Transplant | fecal microbiota transplant biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy sigmoidoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | 3 months |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fecal Microbiota Transplant | fecal microbiota transplant biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy sigmoidoscopy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shaffer | Emory University | 404-778-5033 | virginia.o.shaffer@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2017 | Feb 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012812 | Sigmoidoscopy |
| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
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| sigmoidoscopy | Procedure |
|
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Patients With Favorable Microbiota Profile | 16s ribosomal gene sequencing and metabolomic profile of the gut microbiota | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| Rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increase in stool frequency | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fever | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |