Irritable Bowel Syndrome (IBS)NCT02092402
Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
A study testing Fecal transplantation in people with Irritable Bowel Syndrome (IBS), run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Fecal transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Signed informed consent
- High-butyrate producing microbiota in fecal samples
- Age: 18-65 years
Who cannot join
- 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
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- 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
- Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhea or constipation)
- Gastrointestinal malignancy or polyposis
- History of major gastrointestinal surgery (e.g. gastric bypass)
- Eosinophilic disorders of the gastrointestinal tract
- Current communicable disease (e.g. upper respiratory tract infection)
- Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
- Non-gastrointestinal malignancy
- Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- Comorbidities such as metabolic syndrome, autoimmune diseases, allergies
- Chronic pain syndromes (eg. chronic fatigue syndrome, fibromyalgia)
- Severe or morbid obesity
- Use of immunosuppressive or chemotherapy agents
- Antimicrobial treatment or prophylaxis within the last 6 months
- Females who are pregnant or breast-feeding
- Known clinically significant abnormal laboratory values
- Participation in high-risk sexual behaviors
- Abuse of alcohol or drugs
- Tattoo or body piercing within the last 6 months
- Travel to areas with endemic diarrhea during the last 3 months
- Positive stool testing for C. difficile toxin, ova, parasites, Giarda antigen, cryptosporidium antigen
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Fecal transplantation
- Keywords
- Fecal transplantation, microbiota transplantation, irritable bowel syndrome, IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal transplantationOther
| Study group | Role | What they receive |
|---|---|---|
| Fecal transplantation of own stool | Placebo comparator | Autologous fecal transplantation (own stool) Receives: Other: Fecal transplantation |
| Fecal transplantation (stool from donor) | Experimental | Allogeneic fecal transplantation (from donor) Receives: Other: Fecal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)
Measured: 6 months
Secondary outcomes (8)
Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)
Measured: 2 months
Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)
Measured: 2 months
Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)
Measured: 6 months
Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)
Measured: 2 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)
Measured: 6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the health-related quality of life questionnaire for IBS patients (IBS-QOL)
Measured: 6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)
Measured: 6 months
Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionNov 2016
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert J Brummer, MD, PhD, Principal investigator, University Hospital Örebro, Department of Gastroenterology and Örebro University, School of Health and Medical Sciences, Faculty of Medicine and Health, Örebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092402
- Sponsor's protocol ID
- 2013/180
- Status last verified
- Aug 2019
- First submitted
- 17 Mar 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02092402
- Acronym / sponsor ID
- 2013/180
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Fecal transplantation, microbiota transplantation, irritable bowel syndrome, IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal transplantation of own stool | Placebo comparator | Other: Fecal transplantationAutologous fecal transplantation (own stool) |
| Fecal transplantation (stool from donor) | Experimental | Other: Fecal transplantationAllogeneic fecal transplantation (from donor) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Signed informed consent
- High-butyrate producing microbiota in fecal samples
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal transplantation | Other | Fecal transplantation (stool from donor), Fecal transplantation of own stool |
Primary outcome
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)
Time frame: 6 months
8 secondary outcomes
Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)
Time frame: 2 months
Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)
Time frame: 2 months
Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)
Time frame: 6 months
Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)
Time frame: 2 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)
Time frame: 6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the health-related quality of life questionnaire for IBS patients (IBS-QOL)
Time frame: 6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)
Time frame: 6 months
Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Brummer, MD, PhD principal investigator
University Hospital Örebro, Department of Gastroenterology and Örebro University, School of Health and Medical Sciences, Faculty of Medicine and Health, Örebro, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal transplantation in people with Irritable Bowel Syndrome (IBS), run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.