Irritable Bowel SyndromePhase 2/3NCT02788071
Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
A Phase 2/3 study testing FMT capsules in people with Irritable Bowel Syndrome, run by Aleris-Hamlet Hospitaler København at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- FMT capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Jul 2017
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fulfilled Rome III diagnostic criteria for IBS
- Moderate-severe disease activity (IBS-Symptom Severity Score ≥175)
- Able to read and speak Danish
- Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool
- Age between 18-45 years
- Past and current healthy
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- Normal weight (BMI between 18,5-24,9 kg/m2)
- Normal bowel movements (defined as 1-2 per day and type 3-4 at Bristol Stool Form Scale)
- No medication consumption
Who cannot join
- Other chronic gastrointestinal disease
- Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile
- Positive screening for HIV, Hepatitis B or HCV antibody
- Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures)
- Psychiatric disorder
- Fecal calprotectin ≥ 50 mg/kg
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- Abuse of alcohol or drugs
- Medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines
- Abnormal screening biochemistry
- Abnormal colonoscopy findings
- Pregnant, planned pregnancy or breastfeeding females
- Ingestion of probiotics or antibiotics < 8 weeks before the inclusion
- Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
- Positive stool sample for C. difficile toxin, parasites or other pathogens
- Antibiotic treatment in the past 6 months
- Abuse of alcohol or drugs
- Smoking
- Tattoo or body piercing within the last 6 months
- Allergy, asthma or eczema
- Family history of gastrointestinal diseases
- Participation in high-risk sexual behaviors
- Born by Caesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study
The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).
Read the detailed description
Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity.
Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.
Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- FMT capsules, FMT placebo
- Keywords
- Irritable Bowel Syndrome, Fecal Microbiota Transplantation, Microbiota
- 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.
FMT capsulesDietary supplement
25 capsules per day for 12 days
FMT placeboDietary supplement
25 capsules per day for 12 days
| Study group | Role | What they receive |
|---|---|---|
| FMT capsules | Experimental | FMT capsules Receives: Dietary Supplement: FMT capsules |
| FMT placebo | Placebo comparator | Placebo capsules Receives: Dietary Supplement: FMT placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms score
Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)
Measured: 12 weeks
Secondary outcomes (4)
Change in microbiota diversity
Measured by DNA sequencing
Measured: Day 4, 4 weeks, 12 weeks and 24 weeks
Microbiota diversity IBS patients
Measured by DNA sequencing
Measured: Baseline
Microbiota diversity in healthy donors
Measured by DNA sequencing. To compare with the recipients (IBS patients)
Measured: Baseline
Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores
Measured: Baseline, 4 weeks, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleris-Hamlet Hospitaler København
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, University of Aarhus
- Responsible party
- Principal investigator, Alice Højer Christensen, Aleris-Hamlet Hospitaler København
- Investigators
- Alice Højer Christensen, MD, PhD, Principal investigator, Aleris-Hamlet Hospitaler København
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788071
- Sponsor's protocol ID
- H-15016343
- Status last verified
- Aug 2017
- First submitted
- 30 May 2016
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.
PubMed 29980607
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02788071
- Acronym / sponsor ID
- H-15016343
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Fecal Microbiota Transplantation, Microbiota
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aleris-Hamlet Hospitaler KøbenhavnUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, University of Aarhus
- Study start
- Oct 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 Jun 2016 (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 if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).
Detailed description
Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity.
Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.
Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.
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 |
|---|---|---|
| FMT capsules | Experimental | Dietary Supplement: FMT capsulesFMT capsules |
| FMT placebo | Placebo comparator | Dietary Supplement: FMT placeboPlacebo capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Fulfilled Rome III diagnostic criteria for IBS
- Moderate-severe disease activity (IBS-Symptom Severity Score ≥175)
- Able to read and speak Danish
- Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool
- Age between 18-45 years
Key exclusion criteria (22 listed)
- Other chronic gastrointestinal disease
- Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile
- Positive screening for HIV, Hepatitis B or HCV antibody
- Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures)
- Psychiatric disorder
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 |
|---|---|---|
| FMT capsules25 capsules per day for 12 days | Dietary supplement | FMT capsules |
| FMT placebo25 capsules per day for 12 days | Dietary supplement | FMT placebo |
Primary outcome
symptoms score
Time frame: 12 weeks
Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)
4 secondary outcomes
Change in microbiota diversity
Time frame: Day 4, 4 weeks, 12 weeks and 24 weeks
Microbiota diversity IBS patients
Time frame: Baseline
Microbiota diversity in healthy donors
Time frame: Baseline
Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks
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 2 Aug 2017.
- Derived from this study: PubMed 29980607Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.
- Individual participant dataSharing planned: Yes
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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.
Alice Højer Christensen, MD, PhD principal investigator
Aleris-Hamlet Hospitaler København
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FMT capsules in people with Irritable Bowel Syndrome, run by Aleris-Hamlet Hospitaler København at 1 site in Denmark.
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 9 inclusion and 22 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 2 Aug 2017. 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 Denmark. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
symptoms score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788071, which also lists 1 linked publication.
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 2 Aug 2017.