Status:
COMPLETED
Fecal Transplantation in Patients With IBS
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
Helse Vest
Conditions:
IBS - Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The study will characterize the biology of FMT in the context of IBS prior to wider clinical application of the method. Given the ethical concerns of unknown and long-term adverse effects of FMT thera...
Detailed Description
Primary aims: Detailed characterisation of donor and recipient microbial community composition (by means of 16S rRNA profiling) and determination of the kinetics of changes following FMT Secondary a...
Eligibility Criteria
Inclusion
- Age between 18-and 70 years
- IBS-SSS (IBS-Symptom Severity Scale) score \>175 (175 - 300 represents moderate, \> 300 represent severe IBS).
- All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or alternating constipation and diarrhoea (IBS-A) with bloating or flatulence as predominant symptoms. Only IBS considered post-infectious after the Bergen Giardia outbreak will be included. The severity of global IBS symptoms has to be either moderate ("cannot be ignored but do not influence daily activities") or severe ("influence daily activities"). A decrease of 50 points on the IBS-SSS has been shown to correlate with improvement in clinical symptoms. All patients will undergo appropriate investigations to exclude organic disease.
Exclusion
- History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool or antibiotic use within 1 month prior to FMT, immunocompromised patient defined as taking immuno-suppressive medications, history of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
- Patients who are scheduled for abdominal surgery, pregnant women or patients taking probiotics or taking antibiotics within 4 weeks prior to installation are also excluded from the protocol.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03333291
Start Date
October 1 2016
End Date
June 30 2017
Last Update
November 6 2017
Active Locations (1)
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1
Helse Bergen HF, Haukeland University Hospital
Bergen, Norway, 5021