Faecal Microbiota Transplantation in Patients With Microscopic Colitis

February 20, 2020 updated by: Robert Brummer, Örebro University, Sweden

Microscopic colitis (MC) is a disease with chronic inflammation of the colon that is mostly diagnosed in middle-aged or elderly women. Patients suffer from chronic watery diarrhoea, abdominal pain and weight loss. The aetiology of MC is still unknown but it is hypothesized that MC is caused by a deregulated immune response to a luminal agent in predisposed individuals, and an important role of the intestinal microbiota is suggested.

In the current proof-of-concept study, the effect of faecal microbiota transfer (FMT) in 10 MC patients will be evaluated. FMT consists in the infusion of suspended stool from a healthy donor into the intestine of a patient with the aim to restore a disturbed intestinal microbiota.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be an intervention pilot study with a 12-week and an optional 6-months follow-up period. It will be investigated if the infusion of suspended stool from healthy donors improves the symptoms of MC patients by restoring their disturbed intestinal microbiota. This procedure is known as faecal microbiota transplantation (FMT).

MC patients (n=10) will be randomised to receive FMT using stool from one of two healthy donors.

At baseline, blood samples and mucosal biopsies will be obtained from the descending colon. In addition, faecal samples will be collected and patients will complete symptom questionnaires. The first FMT will be administered by colonoscopy, FMT 2-3 by enemas. Faecal samples will be collected and questionnaires will be completed at different time points during the study. The patients will be followed-up at 6 weeks, 8 weeks, 12 weeks and 6 months after receiving FMT 1, however, the follow-up after 6 months will be optional. Additional biopsies from the descending colon and blood samples will be collected 6 weeks after the first FMT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Örebro County
      • Örebro, Örebro County, Sweden, 70185
        • University Hospital Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria for patients:

  1. Signed informed consent
  2. Active MC diagnosis, defined as >3 stools a day from which at least one should be watery
  3. Willingness to stop budesonide treatment during participation in the trial
  4. Age: 18-70 years

Exclusion criteria for patients

  1. Previous complicated gastrointestinal surgery
  2. Malignant disease except non-melanoma skin cancer
  3. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
  4. C. difficile or other current gastroenteritis
  5. Females who are pregnant or breast-feeding
  6. Severe endometriosis
  7. Antimicrobial treatment 4 weeks prior to first screening visit
  8. Antimicrobial prophylaxis (eg. acne, urinary tract infection)
  9. Regular consumption of probiotic products 4 weeks prior to randomization
  10. Recently diagnosed lactose intolerance (less than 6 months prior to first screening visit)
  11. Recently diagnosed coeliac disease (less than 6 months prior to first screening visit)
  12. Regular intake of NSAIDs (non steroidal anti-inflammatory drugs)
  13. Abuse of alcohol or drugs
  14. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial

Inclusion criteria for donors

  1. Signed informed consent
  2. High-butyrate producing microbiota in faecal samples
  3. Age: 18-65 years

Exclusion criteria for donors

  1. Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhoea or constipation)
  2. First degree relative with IBD
  3. History of or present gastrointestinal malignancy or polyposis
  4. Recent (gastrointestinal) infection (within last 6 months)
  5. History of major gastrointestinal surgery (e.g. gastric bypass)
  6. Eosinophilic disorders of the gastrointestinal tract
  7. Current communicable disease (e.g. upper respiratory tract infection)
  8. Malignant disease and/or patients who are receiving systemic anti-neoplastic agents
  9. Psychiatric diseases (e.g. dementia, depression, schizophrenia, autism, Asperger Syndrome) or other incapacity for adequate cooperation
  10. Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
  11. Autoimmune disease and/or patients receiving immunosuppressive medications
  12. Major relevant allergies (e.g. food allergy, multiple allergies)
  13. Chronic pain syndromes (e.g. fibromyalgia)
  14. Chronic fatigue syndrome
  15. HIV, hepatitis A, B, C or known exposure within the recent 12 months
  16. Obesity (BMI>30) or metabolic syndrome
  17. Antimicrobial treatment or prophylaxis within the last 3 months
  18. Other chronic use of drugs that may affect the microbiome, e.g. proton pump inhibitors
  19. First degree relative with cardiovascular thrombosis before 50 years of age
  20. Females who are pregnant or breast-feeding
  21. Known clinically significant abnormal laboratory values
  22. Participation in high-risk sexual behaviours
  23. Abuse of alcohol or drugs
  24. Tattoo or body piercing within the last 6 months
  25. Travelling in countries with low hygiene or high infection risk for endemic diarrhoea within the last 6 months
  26. Positive stool testing for C. difficile, ova and parasites (e.g. Cyclospora, Isospora, Cryptosporidium), enteric pathogens (e.g. enterohaemorrhagic E. coli, Salmonella, Shigella, Yersinia, Campylobacter, Giarda antigen, amoebas)
  27. Positive stool testing for multiresistant bacteria (e.g. extended-spectrum beta- lactamase (ESBL) producing organisms, multi-resistant Gram-negative bacilli (MRGN) 3 and 4, vancomycin-resistant enterococci (VRE) or methicillin-resistant Staphylococcus aureus (MRSA))
  28. Calprotectin > 50 μg/g of faeces
  29. Positive blood testing for HIV, Hepatitis A, B, C, syphilis, Human T-lymphotropic virus (HTLV), cytomegalovirus (CMV) and Epstein Barr Virus (EBV)
  30. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Faecal microbiota transfer (FMT)
Suspended stool from a healthy donor
Other: Faecal microbiota transfer (FMT)
Suspended stool from a healthy donor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of MC patients in remission six weeks after the first FMT.
Time Frame: 6 weeks
Remission is defined as <3 stools per day and a mean of less than one watery stool per day.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in general health and symptom questionnaire scores
Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months
SHS
6 weeks, 8 weeks, 12 weeks, 6 months
Changes in general health questionnaire scores
Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months
SF-36
6 weeks, 8 weeks, 12 weeks, 6 months
Changes in quality of life questionnaire scores
Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months
EG-5D-5L
6 weeks, 8 weeks, 12 weeks, 6 months
Changes in gastrointestinal symptom questionnaire scores
Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months
GSRS
6 weeks, 8 weeks, 12 weeks, 6 months
Changes in hospital and anxiety depression scores
Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months
HADS
6 weeks, 8 weeks, 12 weeks, 6 months
Changes in number and form of bowel movements
Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months
1-week-diaries
6 weeks, 8 weeks, 12 weeks, 6 months
Changes in faecal and mucosal microbiota composition
Time Frame: faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; mucosal: 6 weeks
16S rRNA-based next generation sequencing
faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; mucosal: 6 weeks
Changes in lymphocyte infiltration
Time Frame: 6 weeks
Immunohistochemistry and flow cytometry
6 weeks
Changes in subepithelial collagen layer
Time Frame: 6 weeks
Immunohistochemistry
6 weeks
Changes in immune cell composition of colonic biopsies
Time Frame: 6 weeks
Immunohistochemistry and flow cytometry
6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Changes in inflammation markers in faecal samples such as faecal calprotectin
Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months
6 weeks, 8 weeks, 12 weeks, 6 months
Changes in metabolite profile in faecal samples and blood
Time Frame: faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; blood: 6 weeks
faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; blood: 6 weeks
Changes in gene expression in mucosal biopsies
Time Frame: 6 weeks
6 weeks
Changes in barrier function markers in colonic biopsies
Time Frame: 6 weeks
6 weeks
Changes in gene expression of butyrate transporters in colonic biopsies
Time Frame: 6 weeks
6 weeks
Changes in markers of inflammation and intestinal barrier function in blood
Time Frame: 6 weeks
6 weeks
Changes in plasma levels of cardiovascular disease markers and platelet responsiveness and aggregation
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Örebro University, Sweden

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Örebro County

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert J Brummer, Professor, MD, Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Microscopic Colitis

Clinical Trials on Faecal microbiota transfer (FMT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings