Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05776914
Other study ID # 22-005385
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 15, 2024
Est. completion date September 2025

Study information

Verified date May 2024
Source Mayo Clinic
Contact Margaret Breen-Lyles
Phone 507-293-0237
Email Breen-Lyles.Margaret@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 post-infection irritable bowel syndrome (PI-IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.


Recruitment information / eligibility

Status Recruiting
Enrollment 43
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Campylobacter PI-IBS defined by Rome III or Rome IV criteria - Non IBS-C - Moderate to severe symptoms defined by IBS-SSS=175 - Able to safely undergo and consent to colonoscopy Exclusion Criteria - Immune deficiency or treatment with immunosuppressive medications - Severe bowel or medical disease precluding administration of bowel prep - Severe bowel or medical disease precluding colonoscopy with conscious sedation - Active cancer - Pregnant or lactating - Abdominal surgery (exception of fundoplication, hernia, appendectomy, cholecystectomy, caesarean section and hysterectomy) - Severe psychiatric disorder (HADS-A or D>16), or diagnosed alcohol or drug abuse disorder - New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry) - Use of treatments known to affect colonic motility (with exception of loperamide) - Diagnosed h/o bleeding disorder - Organic GI diseases (IBD, celiac disease, microscopic colitis) - Chronic kidney or liver disease - Absolute neutrophil count (ANC) <500 IU/ml

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Donor Fecal Microbiota Transplantation
Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
Autologous Fecal Microbiota Transplantation
Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Locations

Country Name City State
United States Mayo Clinic in Minnesota Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Madhusudan (Madhu) Grover, MBBS

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Changes in in vivo excretion of 2-24 hr lactulose excretion Measured by permeability testing Baseline, 12 weeks
Secondary 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
Secondary 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
Secondary Alistipes putredinis proportion post-FMT Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT) 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT03720314 - Microbiota Profiling in IBS
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT05213910 - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains N/A
Recruiting NCT05985018 - Traditional Dietary Advice Vs. Mediterranean Diet in IBS N/A
Completed NCT04486469 - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study. N/A
Completed NCT06407609 - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS N/A
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04145856 - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico Phase 4
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Not yet recruiting NCT05157867 - In Vivo Effects of Amylase Trypsin Inhibitors N/A
Not yet recruiting NCT05100719 - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION) N/A
Recruiting NCT05001997 - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome N/A
Recruiting NCT02953171 - Probiotics in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT02977975 - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT03266068 - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed NCT02980406 - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level N/A
Completed NCT03318614 - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster Phase 2/Phase 3