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The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donor Fecal Microbiota Transplantation Group | Experimental | Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor |
|
| Autologous Fecal Microbiota Transplantation Group | Placebo Comparator | Subjects will receive a fecal microbiota transplantation (FMT) using their own stool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donor Fecal Microbiota Transplantation | Biological | Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of responders | Number of subjects receiving the donor fecal microbiota transplantation identified as a responder defined as a decrease of ≥50 points in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from baseline. The Irritable Bowel Syndrome Symptom Severity Score scale has a possible range of scores from 0-500. Mild cases are classified as a score of 75-175, moderate cases are classified as a score of 175-300, and severe cases are classified as a score of >300. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in level of fecal proteolytic activity | The level of fecal proteolytic activity will be measured at baseline and again at 12 weeks. The proteolytic activity is measured using a standardized FITC Casein assay that relies on the activity of proteases in the sample to digest casein protein. | Baseline, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonah Pedelty, MS | Contact | 507-538-7774 | pedelty.jonah@mayo.edu | |
| Margaret Breen-Lyles | Contact | 507-422-5759 | breen-lyles.margaret@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Madhusudan Grover, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Autologous Fecal Microbiota Transplantation | Biological | Single fecal microbiota transplantation using 50 gm of stool collected from the same individual |
|
| Changes in in vivo excretion of 2-24 hr lactulose excretion |
Measured by permeability testing |
| Baseline, 12 weeks |
| Number of weekly responders | Number of subjects to meet responder criteria of ≥30% decrease in average of worst abdominal pain in past 24 hours plus ≥50% decrease in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (compared with baseline) | 12 weeks |
| Global Adequate Relief Questionnaire | Number of subjects to report adequate relief of IBS symptoms, measured by answering yes to question "In the past 7 days have you had adequate relief of your IBS symptoms?" | 12 weeks |
| Alistipes putredinis proportion post-FMT | Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT) | 12 weeks |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |