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New treatment option for Irritable Bowel Syndrome
Official title Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome Without Constipation
ClinicalTrials.gov ID: NCT05803980
What this study is testing
- What it's testing
- Irritable bowel syndrome (IBS) is a complex multifactorial functional disorder, whose pathophysiology is largely associated to an impairment of the intestinal microbiota composition, namely dysbiosis. Thus, the modulation of the gut microbiota has been proposed as a possible therapeutic strategy for IBS patients alongside with current available drugs.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to express and give informed consent
- Age ≥ 18 years
- Diagnosis of diarrhoea-predominant or unclassified IBS, according to the Rome IV criteria
- Have performed a colonoscopy within the last 5 years that has ruled out intestinal diseases
You likely can't join if
- Taking antibiotics or probiotics within the 8 weeks before the baseline visit
- Patients with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis or eosinophilic gastroenteritis)...
- Uncontrolled heart failure or severe heart disease with EF \< 30%
- Severe respiratory failure
- Serious psychiatric conditions or psychological instability according to the clinician
- Contraindication to fecal microbiota transplantation (high risk of complications related to colonoscopy)
See the full eligibility criteria
- Ability to express and give informed consent
- Age ≥ 18 years
- Diagnosis of diarrhoea-predominant or unclassified IBS, according to the Rome IV criteria
- Have performed a colonoscopy within the last 5 years that has ruled out intestinal diseases
- Taking antibiotics or probiotics within the 8 weeks before the baseline visit
- Patients with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis or eosinophilic gastroenteritis), malignant neoplasms of the gastroenteric tract, celiac disease, diverticular...
- Uncontrolled heart failure or severe heart disease with EF \< 30%
- Severe respiratory failure
- Serious psychiatric conditions or psychological instability according to the clinician
- Contraindication to fecal microbiota transplantation (high risk of complications related to colonoscopy)
- Previous abdominal surgery on the gastroenteric tract (except cholecystectomy, appendectomy and other types of surgery not involving the digestive tract)
- Patients with cutaneous enterostomy
- Pregnancy or lactation
- Concurrent enrollment in other treatment experimental protocols
- Personality unstable or unable to adhere to protocol procedures
- Any clinical condition which, in the opinion of the investigators, may contraindicate enrollment in the study
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy. 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.