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New treatment option for Irritable Bowel Syndrome
Official title Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
ClinicalTrials.gov ID: NCT05361785
What this study is testing
What is FMT?
FMT 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
- Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor.
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 75
You may be able to join if
- Adults, age 18-75 years, knowledge of the Finnish language
- IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial
- The patient must consume low FODMAP diet to control IBS symptoms
- Patient must sign the informed consent
You likely can't join if
- Diagnosed allergies to food components in the study dietary protocol
- Pregnancy and breastfeeding
- Antibiotic treatment less than three months prior enrolment
- Faecal incontinence, i.e., inability to retain enema
- Abuse of drugs, alcohol or medications
- Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea.
See the full eligibility criteria
- Adults, age 18-75 years, knowledge of the Finnish language
- IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial
- The patient must consume low FODMAP diet to control IBS symptoms
- Patient must sign the informed consent
- Diagnosed allergies to food components in the study dietary protocol
- Pregnancy and breastfeeding
- Antibiotic treatment less than three months prior enrolment
- Faecal incontinence, i.e., inability to retain enema
- Abuse of drugs, alcohol or medications
- Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea.
- Severe psychiatric or neurologic condition decreasing patient's compliance
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Helsinki and Uusimaa, Finland
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Helsinki and Uusimaa, Finland. 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.