NCT02092402

Brief Summary

The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

March 17, 2014

Last Update Submit

August 27, 2019

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Fecal transplantationmicrobiota transplantationirritable bowel syndromeIBS

Outcome Measures

Primary Outcomes (1)

  • Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)

    6 months

Secondary Outcomes (8)

  • Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)

    2 months

  • Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)

    2 months

  • Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)

    6 months

  • Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)

    2 months

  • Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Fecal transplantation of own stool

PLACEBO COMPARATOR

Autologous fecal transplantation (own stool)

Other: Fecal transplantation

Fecal transplantation (stool from donor)

EXPERIMENTAL

Allogeneic fecal transplantation (from donor)

Other: Fecal transplantation

Interventions

Fecal transplantationOTHER
Fecal transplantation (stool from donor)Fecal transplantation of own stool

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Fulfilled Rome III diagnostic criteria for IBS, and frequency of IBS pain or discomfort for at least 2 days a week in the last 12 weeks
  • Age: 18-65 years

You may not qualify if:

  • High proportion of butyrate-producing microbiota in fecal samples
  • Known organic gastrointestinal disease (e.g. IBD)
  • Previous complicated gastrointestinal surgery
  • Non-gastrointestinal malignancy
  • Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
  • Females who are pregnant or breast-feeding
  • Severe endometriosis
  • Antimicrobial treatment 4 weeks prior to first screening visit
  • Antimicrobial prophylaxis (eg. acne, urinary tract infection)
  • Regular consumption of probiotic products 4 weeks prior to randomization
  • Recently (within the last 3 months) diagnosed lactose intolerance
  • Celiac disease
  • Abuse of alcohol or drugs
  • Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial
  • Signed informed consent
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Örebro

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Robert J Brummer, MD, PhD

    University Hospital Örebro, Department of Gastroenterology and Örebro University, School of Health and Medical Sciences, Faculty of Medicine and Health, Örebro, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

September 1, 2013

Primary Completion

November 1, 2016

Study Completion

June 1, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

SE(1)