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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
Single fecal microbiota transplantation using 50 gm of stool collected from the same individual
Mayo Clinic in Minnesota
Rochester, Minnesota, United States
RECRUITINGPercentage 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.
Time frame: 12 weeks
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.
Time frame: Baseline, 12 weeks
Changes in in vivo excretion of 2-24 hr lactulose excretion
Measured by permeability testing
Time frame: 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)
Time frame: 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?"
Time frame: 12 weeks
Alistipes putredinis proportion post-FMT
Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT)
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Time frame: 12 weeks