IBS - Irritable Bowel SyndromeNCT03333291
Fecal Transplantation in Patients With IBS
A study testing fecal suspension in people with IBS - Irritable Bowel Syndrome, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The study will characterize the biology of FMT in the context of IBS prior to wider clinical application of the method. Given the ethical concerns of unknown and long-term adverse effects of FMT therapy, the study will include patients only with moderate to severe symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- fecal suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2016to 30 Jun 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-and 70 years
- IBS-SSS (IBS-Symptom Severity Scale) score >175 (175 - 300 represents moderate, > 300 represent severe IBS).
- All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or alternating constipation and diarrhoea (IBS-A) with bloating or flatulence as predominant symptoms. Only IBS considered post-infectious after the Bergen Giardia outbreak will be included. The severity of global IBS symptoms has to be either moderate ("cannot be ignored but do not influence daily activities") or severe ("influence daily activities"). A decrease of 50 points on the IBS-SSS has been shown to correlate with improvement in clinical symptoms. All patients will undergo appropriate investigations to exclude organic disease.
Who cannot join
- History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool or antibiotic use within 1 month prior to FMT, immunocompromised patient defined as taking immuno-suppressive medications, history of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
- Patients who are scheduled for abdominal surgery, pregnant women or patients taking probiotics or taking antibiotics within 4 weeks prior to installation are also excluded from the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisations of Microbial Community Composition and Kinetics Following Faecal Microbiota Transplantation in Patients WITH IRRITABLE BOWEL SYNDROME
The study will characterize the biology of FMT in the context of IBS prior to wider clinical application of the method. Given the ethical concerns of unknown and long-term adverse effects of FMT therapy, the study will include patients only with moderate to severe symptoms. IBS is a heterogenous disorder and it is important to characterize the patients, and study as homogeneous patient populations as possible. Therefore the study will only include post-infectious IBS patients after the Giardia outbreak.
Read the detailed description
Primary aims:
Detailed characterisation of donor and recipient microbial community composition (by means of 16S rRNA profiling) and determination of the kinetics of changes following FMT
Secondary aims:
- Determination of interactions of importance to persisting recipient gut microbiota.
- Evaluate safety of FMT in an IBS population
- To evaluate the efficacy of FMT in relieving symptoms in selected patients with IBS in an open pilot trial in order to have the possibility to calculate number of patients needed when planning future controlled studies.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- fecal suspension
- 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 suspensionDietary supplement
helathy donor fecal suspension administered by duodenal scope
| Study group | Role | What they receive |
|---|---|---|
| Fecal transplantation | Experimental | Duodenal transfer of healthy donor fecal suspension Receives: Dietary Supplement: fecal suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool microbiota changes
abundance of major microbial taxa in fecal transplant post transplantation
Measured: up to 28 weeks
Secondary outcomes (1)
Global improvement in IBS symptoms
Patient questionnaires IBSS-S
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Oct 2016
- Primary completion15 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open pilot study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333291
- Sponsor's protocol ID
- 2013/1497
- Status last verified
- Nov 2017
- First submitted
- 25 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mazzawi T, El-Salhy M, Lied GA, Hausken T. The Effects of Fecal Microbiota Transplantation on the Symptoms and the Duodenal Neurogenin 3, Musashi 1, and Enteroendocrine Cells in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. Front Cell Infect Microbiol. 2021 May 12;11:524851. doi: 10.3389/fcimb.2021.524851. eCollection 2021.
PubMed 34055657Mazzawi T, Hausken T, Hov JR, Valeur J, Sangnes DA, El-Salhy M, Gilja OH, Hatlebakk JG, Lied GA. Clinical response to fecal microbiota transplantation in patients with diarrhea-predominant irritable bowel syndrome is associated with normalization of fecal microbiota composition and short-chain fatty acid levels. Scand J Gastroenterol. 2019 Jun;54(6):690-699. doi: 10.1080/00365521.2019.1624815. Epub 2019 Jun 13.
PubMed 31190584Mazzawi T, Lied GA, Sangnes DA, El-Salhy M, Hov JR, Gilja OH, Hatlebakk JG, Hausken T. The kinetics of gut microbial community composition in patients with irritable bowel syndrome following fecal microbiota transplantation. PLoS One. 2018 Nov 14;13(11):e0194904. doi: 10.1371/journal.pone.0194904. eCollection 2018.
PubMed 30427836
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisations of Microbial Community Composition and Kinetics Following Faecal Microbiota Transplantation in Patients WITH IRRITABLE BOWEL SYNDROME
- ClinicalTrials.gov ID
- NCT03333291
- Acronym / sponsor ID
- 2013/1497
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Vest
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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 study will characterize the biology of FMT in the context of IBS prior to wider clinical application of the method. Given the ethical concerns of unknown and long-term adverse effects of FMT therapy, the study will include patients only with moderate to severe symptoms. IBS is a heterogenous disorder and it is important to characterize the patients, and study as homogeneous patient populations as possible. Therefore the study will only include post-infectious IBS patients after the Giardia outbreak.
Detailed description
Primary aims:
Detailed characterisation of donor and recipient microbial community composition (by means of 16S rRNA profiling) and determination of the kinetics of changes following FMT
Secondary aims:
- Determination of interactions of importance to persisting recipient gut microbiota.
- Evaluate safety of FMT in an IBS population
- To evaluate the efficacy of FMT in relieving symptoms in selected patients with IBS in an open pilot trial in order to have the possibility to calculate number of patients needed when planning future controlled studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open pilot study
| Arm | Type | Receives |
|---|---|---|
| Fecal transplantation | Experimental | Dietary Supplement: fecal suspensionDuodenal transfer of healthy donor fecal suspension |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-and 70 years
- IBS-SSS (IBS-Symptom Severity Scale) score >175 (175 - 300 represents moderate, > 300 represent severe IBS).
- All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or alternating constipation and diarrhoea (IBS-A) with bloating or flatulence as predominant symptoms. Only IBS considered post-infectious after the Bergen Giardia outbreak will be included. The severity of global IBS symptoms has to be either moderate ("cannot be ignored but do not influence daily activities") or severe ("influence daily activities"). A decrease of 50 points on the IBS-SSS has been shown to correlate with improvement in clinical symptoms. All patients will undergo appropriate investigations to exclude organic disease.
Key exclusion criteria (2 listed)
- History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool or antibiotic use within 1 month prior to FMT, immunocompromised patient defined as taking immuno-suppressive medications, history of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
- Patients who are scheduled for abdominal surgery, pregnant women or patients taking probiotics or taking antibiotics within 4 weeks prior to installation are also excluded from the protocol.
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 suspensionhelathy donor fecal suspension administered by duodenal scope | Dietary supplement | Fecal transplantation |
Primary outcome
Stool microbiota changes
Time frame: up to 28 weeks
abundance of major microbial taxa in fecal transplant post transplantation
1 secondary outcome
Global improvement in IBS symptoms
Time frame: up to 28 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 6 Nov 2017.
- Derived from this study: PubMed 34055657Mazzawi T, El-Salhy M, Lied GA, Hausken T. The Effects of Fecal Microbiota Transplantation on the Symptoms and the Duodenal Neurogenin 3, Musashi 1, and Enteroendocrine Cells in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. Front Cell Infect Microbiol. 2021 May 12;11:524851. doi: 10.3389/fcimb.2021.524851. eCollection 2021.
- Derived from this study: PubMed 31190584Mazzawi T, Hausken T, Hov JR, Valeur J, Sangnes DA, El-Salhy M, Gilja OH, Hatlebakk JG, Lied GA. Clinical response to fecal microbiota transplantation in patients with diarrhea-predominant irritable bowel syndrome is associated with normalization of fecal microbiota composition and short-chain fatty acid levels. Scand J Gastroenterol. 2019 Jun;54(6):690-699. doi: 10.1080/00365521.2019.1624815. Epub 2019 Jun 13.
- Derived from this study: PubMed 30427836Mazzawi T, Lied GA, Sangnes DA, El-Salhy M, Hov JR, Gilja OH, Hatlebakk JG, Hausken T. The kinetics of gut microbial community composition in patients with irritable bowel syndrome following fecal microbiota transplantation. PLoS One. 2018 Nov 14;13(11):e0194904. doi: 10.1371/journal.pone.0194904. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 suspension in people with IBS - Irritable Bowel Syndrome, run by Haukeland University Hospital at 1 site in Norway.
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 3 inclusion and 2 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 6 Nov 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 Norway. 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. 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?
Stool microbiota changes (time frame: up to 28 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 NCT03333291, which also lists 3 linked publications.
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 6 Nov 2017.