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Faecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action

NCT04236843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2023-08-22

No results posted yet for this study

Summary

Two hundrad patients are randomized to either 90 g transplant, 90 g transplant twice with 1week interval into the distal small intestine via working channel of a gastroscope, or to 90 g transplant into the coecum of the colon via working channel of a colonoscope. The patients shall complete 5 questionnaires measuring symptoms, fatigue and quality of life and collect a feces sample at the baseline, and at 3, 6 and 12 months after FMT. Dysbiosis and fecal bacterial are determined by using 16S rRNA gene.

Conditions

  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Feces

Feces from healthy donor

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Helse Fonna

    lead OTHER

Principal Investigators

  • Magdy El-Salhy, MD,PhD · Helse Fonna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2022-03-25
Completion
2022-03-25

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04236843 on ClinicalTrials.gov