Gut microbiota role in irritable bowel syndrome: New therapeutic strategies.
Eleonora Distrutti, Lorenzo Monaldi, Patrizia Ricci...
https://pubmed.ncbi.nlm.nih.gov/26900286Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
ID03613545
Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Led by Guangzhou First People's Hospital · Updated on 2021-08-03
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating fecal microbiota transplantation (FMT) as a potential treatment for Irritable Bowel Syndrome (IBS). FMT involves transferring a healthy donor's gut microbiota into a patient's colon to restore intestinal flora. This study aims to determine the effectiveness and safety of FMT in patients with IBS, a condition that currently lacks well-established treatments. The trial is sponsored by Guangzhou First People's Hospital and includes follow-up assessments over six months. Participants will be randomly assigned to one of three groups: receiving FMT through colon infusion of 200 mL donor fecal suspension, receiving a sham infusion, or receiving traditional treatments such as probiotics, antibiotics, or antidepressants as per guidelines. The FMT is administered at least twice, and treatment effects are monitored over time. The study design includes single masking and follows Phase 2 and Phase 3 clinical trial protocols. During the trial, participants will complete questionnaires assessing IBS symptom severity, quality of life, and mental health at the start, and then again at one, three, and six months. Researchers will monitor changes using the IBS Symptom Severity Score (IBS-SSS), IBS Quality of Life (IBS-QOL) questionnaire, and Hamilton Depression and Anxiety Rating Scales. The total participation duration spans at least six months, with evaluations to assess treatment safety and effects throughout this period.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent
- Male or female aged over 18 and under 75 years
- Diagnosed with Irritable Bowel Syndrome as defined by Rome IV criteria
You will not qualify if you...
- Pregnant or unable to commit to follow-up of at least 6 months
- Unable to give informed consent
- Suffering from severe disease such as liver or kidney failure, cancers, intestinal diseases, inflammatory bowel disease, or C difficile infection
- Unable to undergo endoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At least two times according to associated guidelines
Participants receive fecal microbiota transplantation or placebo infusions, or traditional treatments such as probiotics, antibiotics, or antidepressants according to associated guidelines.
At least 2 treatment visits (in-person)
Follow-up
Duration - At least 6 months
Participants are followed for at least six months with assessments using questionnaires to evaluate symptoms and quality of life.
Visits at 1 month, 3 months, and 6 months after treatment
Trial Site Locations
Total: 1 location
1
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
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Research Team
H
Hongli Huang, MM
H
Huiting Chen, MM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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