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Completed

NCT Number: NCT03561519

FMT in the Treatment of IBS

52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, Finland

About this study

52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of IBS based on Rome III criteria
  • Having received traditional treatment for at least 1 month
  • Availability of consecutive fecal samples over one year.
  • Compliance to attend ileocolonoscopy and FMT procedure.
  • 18-75 years

Exclusion criteria

  • Unable to provide informed consent
  • Antibiotic therapy in past 3 months
  • Inflammatory bowel disease (IBD)

Treatment and study plan

Fecal microbiota transplantation (FMT)

Other

Fecal suspension administered in colonoscopy into the cecum of the patient.

Placebo

Other

As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.

Primary outcomes

  1. IBS symptom relieve

    Time frame: 52 weeks

    Reduction IBS-SSS by 50 points, The irritable bowel severity score system in which the maximum achievable score is 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.( Aliment Pharmacol Ther. 1997 Apr;11(2):395-402.)

Sponsors and collaborators

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care

Other

Collaborators

  • Helsinki University Central Hospital
  • University of Helsinki

Registry information

Official study title

FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME

Acronym: FMT-IBS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2018
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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