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New treatment option for Irritable Bowel Syndrome
Official title Fecal Microbiota Transplantation for IBS
ClinicalTrials.gov ID: NCT05776914
What this study is testing
What is Donor Fecal Microbiota Transplantation?
Donor Fecal Microbiota Transplantation is an investigational medicine, being studied as a potential treatment for irritable bowel syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- IBS defined by Rome IV criteria
- Non IBS-C
- Moderate to severe symptoms defined by IBS-SSS≥175
- Able to safely undergo and consent to colonoscopy
You likely can't join if
- 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 splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh...
See the full eligibility criteria
- IBS defined by Rome IV criteria
- Non IBS-C
- Moderate to severe symptoms defined by IBS-SSS≥175
- Able to safely undergo and consent to colonoscopy
- 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 splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.