Fecal Microbiota Transplantation for IBS

Launched by MADHUSUDAN (MADHU) GROVER, MBBS · Mar 17, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called fecal microbiota transplantation (FMT) for people suffering from a specific type of Irritable Bowel Syndrome (IBS) known as post-infection IBS. The goal is to see if using stool from a special donor can help improve symptoms for patients who have moderate to severe IBS symptoms. In particular, the study is focusing on patients who have had an infection caused by a bacteria called Campylobacter and are experiencing diarrhea as a result.

To be eligible for this study, participants need to be between 18 and 65 years old, have a diagnosis of post-infection IBS, and be able to safely undergo a procedure called colonoscopy. However, certain health conditions, like severe bowel diseases or active cancer, may disqualify someone from participating. If you join the trial, you can expect to receive the FMT treatment and be monitored for safety and effectiveness. This could be an important opportunity for individuals who have not found relief from their IBS symptoms through other treatments.

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• • 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 splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy, 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