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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03333291
Other study ID # 2013/1497
Secondary ID
Status Completed
Phase N/A
First received October 25, 2017
Last updated November 3, 2017
Start date October 1, 2016
Est. completion date June 30, 2017

Study information

Verified date November 2017
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 therapy, the study will include patients only with moderate to severe symptoms. IBS is a heterogenous disorder and it is important to characterize the patients, and study as homogeneous patient populations as possible. Therefore the study will only include post-infectious IBS patients after the Giardia outbreak.


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 aims:

- Determination of interactions of importance to persisting recipient gut microbiota.

- Evaluate safety of FMT in an IBS population

- To evaluate the efficacy of FMT in relieving symptoms in selected patients with IBS in an open pilot trial in order to have the possibility to calculate number of patients needed when planning future controlled studies.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date June 30, 2017
Est. primary completion date June 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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.

Study Design


Intervention

Dietary Supplement:
fecal suspension
helathy donor fecal suspension administered by duodenal scope

Locations

Country Name City State
Norway Helse Bergen HF, Haukeland University Hospital Bergen

Sponsors (2)

Lead Sponsor Collaborator
Haukeland University Hospital Helse Vest

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stool microbiota changes abundance of major microbial taxa in fecal transplant post transplantation up to 28 weeks
Secondary Global improvement in IBS symptoms Patient questionnaires IBSS-S up to 28 weeks
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