Irritable Bowel SyndromeNCT02299973
Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating
A study testing FMT with donor stool and FMT with own stool in people with Irritable Bowel Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- FMT with donor stool and FMT with own stool
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria for patients:
- signed informed consent
- Irritable bowel syndrome with predominant diarrhoea as defined by the ROME III criteria and with symptoms of abdominal bloating
- IBS symptom score > 3 on at least 2 subscores (abdominal discomfort, abdominal bloating, abdominal pain, urgency, stool frequency, stool consistency)
- Exclusion Criteria for patients:
- predominant constipation as defined by Rome III criteria
- pregnancy or inadequate anti conception for the duration of the trial
- celiac disease
- any contra-indications for colonoscopy
- structural abnormalities of the colon (e.g. ileocecal resection, gastric bypass)
- severe gastro-intestinal comorbidities (e.g. IBD, coloncarcinoma)
- non gastro-intestinal malignancy
- severe psychiatric comorbidity which had important effects on the quality of life
- antimicrobial treatment 4 weeks prior to screening visit
- treatment with probiotics 2 weeks prior to screening visit
- recent diagnosis of lactose intolerance (< 3 months before screening visit)
- any severe comorbidity that might interfere with the study course as determined by the treating physician
- Inclusion criteria for donors
- age 18 - 75 years
- signed informed consent
- normal screening protocol which includes screening for infectious diseases (eg. blood HIV, Syphilis, Hepatitis B or C; stool: enteropathogens, clostridium, ESBL, CPE)
- Exclusion criteria for donors
- presence of gastrointestinal symptoms
- gastro-intestinal or other important comorbidity
- obesity or metabolic syndrome
- history of malignancy both gastrointestinal or systemic
- presence of known colon polyps
- recent placing of piercings/tattoos
- sexual risk behaviour
- antimicrobial therapy 3 months prior to donation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating: a Double Blind, Placebo Controlled Randomised Clinical Trial
Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been shown to be an effective means of correcting this imbalance in the gut microbiota, especially in patients with recurrent Clostridium difficile infections where it has become a preferred treatment strategy.
In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal bloating was seen three months after transplantation.
In this study the effects of FMT on patients with IBS without constipation and bloating will be investigated in a double blind, placebo controlled RCT.
Read the detailed description
Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been shown to be an effective means of correcting this imbalance in the gut microbiota, especially in patients with recurrent Clostridium difficile infections where it has become a preferred treatment strategy.
In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal bloating was seen three months after transplantation.
In this study the effects of FMT on patients with IBS without constipation and bloating will be investigated in a double blind, placebo controlled RCT. Donors for this study will be recruited from a healthy donor pool who will donate stool after clearance of a strict inclusion protocol which will assess the presence of any infectious diseases. Stool will be frozen following the protocol described in Hamilton et al 2012. Patients will deliver a stool portion that will be frozen as well.
At time of FMT, patients will be randomised in a double blinded fashion to the treatment arm (healthy donor stool) or placebo arm (own stool). Transplantation will be preformed by means of a colonoscopy with deliverance in the right colon and ileum.
Following FMT patients will be followed clinically with questionnaires and regular visits to the clinic. Stool samples will be collected on a regular basis for microbiome analysis.
At the end of the study, patients from the placebo-group will be given the opportunity to be transplanted with healthy donor stool if necessary. Follow-up will continu for a total duration of one year.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- FMT with donor stool, FMT with own stool
- Keywords
- irritable bowel syndrome, fecal microbiota transplantation, bloating
- 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 with donor stoolProcedure or surgery
Also called Fecal microbiota transplantation with healthy donor stool
fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from a healthy pool of donors and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the treatment group
FMT with own stoolProcedure or surgery
Also called Fecal microbiota transplantation with own stool
fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from the patients and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the control group
| Study group | Role | What they receive |
|---|---|---|
| Placebo group (FMT with own stool) | Placebo comparator | Fecal microbiota transplantation with patient's own stool Receives: Procedure: FMT with own stool |
| Treatment group (FMT with donor stool) | Experimental | Fecal microbiota transplantation with healthy donor stool Receives: Procedure: FMT with donor stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of overall IBS symptoms (Key question 1)
On a weekly basis patients will assess their overall IBS symptoms by answering a key question (Are your overall symptoms improved as compared to before the treatment?)
Measured: 3 months after FMT
Reduction of abdominal bloating (Key question 2)
On a weekly basis patients will assess their sensation of abdominal bloating by answering a key question (Is your overall sensation of bloating improved by FMT as compared to before treatment?)
Measured: 3 months after FMT
Secondary outcomes (7)
Changes in fecal microbiome composition (Illumina sequencing)
Before and after FMT stool samples will be collected on a regular basis to assess the changes in microbiome changes (Illumina sequencing).
Measured: 3 months after FMT
Changes in IBS symptom scores at three months after FMT
IBS symptoms will be assessed by use of a daily symptom diary which will measure abdominal discomfort, pain, bloating, flatulence, stool frequency, stool consistency and urgency
Measured: 3 months after FMT
Changes in IBS symptom scores at six months post FMT
Key questions and symptom diary scores will be repeated 6 months after FMT to assess the duration of effects
Measured: 6 months
Changes in IBS symtom scores at 9 months post FMT
Key questions and symptom diary scores will be repeated 9 months after FMT to assess the duration of effects
Measured: 9 months
Changes in IBS symptom scores at 1 year post FMT
Key questions and symptom diary scores will be repeated 1 year after FMT to assess the duration of effects
Measured: 1 year
Composition of mucosal-adherent microbiota (Illumina sequencing)
Composition of mucosal-adherent microbiota will be assessed by Illumina sequencing. Biopsies will be taken at time of FMT and snap frozen for further analysis.
Measured: 3 months
Changes of IBS symptom scores in patients who undergo an off-trial FMT
After unblinding patients who were included in the placebo group, will be offered the possibility of FMT. Effects in these patients will be followed by IBS symptoms scores and answers to key questions at 3 months post FMT
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gastro-enterologie, University Hospital, Ghent
- Investigators
- Danny De Looze, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299973
- Sponsor's protocol ID
- UGent_Gastro_001
- Status last verified
- Dec 2017
- First submitted
- 11 Nov 2014
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dupont HL. Review article: evidence for the role of gut microbiota in irritable bowel syndrome and its potential influence on therapeutic targets. Aliment Pharmacol Ther. 2014 May;39(10):1033-42. doi: 10.1111/apt.12728. Epub 2014 Mar 25.
PubMed 24665829Kassinen A, Krogius-Kurikka L, Makivuokko H, Rinttila T, Paulin L, Corander J, Malinen E, Apajalahti J, Palva A. The fecal microbiota of irritable bowel syndrome patients differs significantly from that of healthy subjects. Gastroenterology. 2007 Jul;133(1):24-33. doi: 10.1053/j.gastro.2007.04.005. Epub 2007 Apr 14.
PubMed 17631127van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PubMed 23323867Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1.
PubMed 23852569Holvoet T, Joossens M, Vazquez-Castellanos JF, Christiaens E, Heyerick L, Boelens J, Verhasselt B, van Vlierberghe H, De Vos M, Raes J, De Looze D. Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial. Gastroenterology. 2021 Jan;160(1):145-157.e8. doi: 10.1053/j.gastro.2020.07.013. Epub 2020 Jul 15.
PubMed 32681922
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating: a Double Blind, Placebo Controlled Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02299973
- Acronym / sponsor ID
- UGent_Gastro_001
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, fecal microbiota transplantation, bloating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Nov 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.
Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been shown to be an effective means of correcting this imbalance in the gut microbiota, especially in patients with recurrent Clostridium difficile infections where it has become a preferred treatment strategy.
In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal bloating was seen three months after transplantation.
In this study the effects of FMT on patients with IBS without constipation and bloating will be investigated in a double blind, placebo controlled RCT.
Detailed description
Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been shown to be an effective means of correcting this imbalance in the gut microbiota, especially in patients with recurrent Clostridium difficile infections where it has become a preferred treatment strategy.
In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal bloating was seen three months after transplantation.
In this study the effects of FMT on patients with IBS without constipation and bloating will be investigated in a double blind, placebo controlled RCT. Donors for this study will be recruited from a healthy donor pool who will donate stool after clearance of a strict inclusion protocol which will assess the presence of any infectious diseases. Stool will be frozen following the protocol described in Hamilton et al 2012. Patients will deliver a stool portion that will be frozen as well.
At time of FMT, patients will be randomised in a double blinded fashion to the treatment arm (healthy donor stool) or placebo arm (own stool). Transplantation will be preformed by means of a colonoscopy with deliverance in the right colon and ileum.
Following FMT patients will be followed clinically with questionnaires and regular visits to the clinic. Stool samples will be collected on a regular basis for microbiome analysis.
At the end of the study, patients from the placebo-group will be given the opportunity to be transplanted with healthy donor stool if necessary. Follow-up will continu for a total duration of one year.
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 |
|---|---|---|
| Placebo group (FMT with own stool) | Placebo comparator | Procedure: FMT with own stoolFecal microbiota transplantation with patient's own stool |
| Treatment group (FMT with donor stool) | Experimental | Procedure: FMT with donor stoolFecal microbiota transplantation with healthy donor stool |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 with donor stoolAlso: Fecal microbiota transplantation with healthy donor stoolfecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from a healthy pool of donors and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the treatment group | Procedure or surgery | Treatment group (FMT with donor stool) |
| FMT with own stoolAlso: Fecal microbiota transplantation with own stoolfecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from the patients and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the control group | Procedure or surgery | Placebo group (FMT with own stool) |
Primary outcome
Reduction of overall IBS symptoms (Key question 1)
Time frame: 3 months after FMT
On a weekly basis patients will assess their overall IBS symptoms by answering a key question (Are your overall symptoms improved as compared to before the treatment?)
Reduction of abdominal bloating (Key question 2)
Time frame: 3 months after FMT
On a weekly basis patients will assess their sensation of abdominal bloating by answering a key question (Is your overall sensation of bloating improved by FMT as compared to before treatment?)
7 secondary outcomes
Changes in fecal microbiome composition (Illumina sequencing)
Time frame: 3 months after FMT
Changes in IBS symptom scores at three months after FMT
Time frame: 3 months after FMT
Changes in IBS symptom scores at six months post FMT
Time frame: 6 months
Changes in IBS symtom scores at 9 months post FMT
Time frame: 9 months
Changes in IBS symptom scores at 1 year post FMT
Time frame: 1 year
Composition of mucosal-adherent microbiota (Illumina sequencing)
Time frame: 3 months
Changes of IBS symptom scores in patients who undergo an off-trial FMT
Time frame: 3 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 8 Dec 2017.
- Background: PubMed 24665829Dupont HL. Review article: evidence for the role of gut microbiota in irritable bowel syndrome and its potential influence on therapeutic targets. Aliment Pharmacol Ther. 2014 May;39(10):1033-42. doi: 10.1111/apt.12728. Epub 2014 Mar 25.
- Background: PubMed 17631127Kassinen A, Krogius-Kurikka L, Makivuokko H, Rinttila T, Paulin L, Corander J, Malinen E, Apajalahti J, Palva A. The fecal microbiota of irritable bowel syndrome patients differs significantly from that of healthy subjects. Gastroenterology. 2007 Jul;133(1):24-33. doi: 10.1053/j.gastro.2007.04.005. Epub 2007 Apr 14.
- Background: PubMed 23323867van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
- Background: PubMed 23852569Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1.
- Derived from this study: PubMed 32681922Holvoet T, Joossens M, Vazquez-Castellanos JF, Christiaens E, Heyerick L, Boelens J, Verhasselt B, van Vlierberghe H, De Vos M, Raes J, De Looze D. Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial. Gastroenterology. 2021 Jan;160(1):145-157.e8. doi: 10.1053/j.gastro.2020.07.013. Epub 2020 Jul 15.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Danny De Looze, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMT with donor stool and FMT with own stool in people with Irritable Bowel Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Dec 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 Belgium. 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?
Reduction of overall IBS symptoms (Key question 1) (time frame: 3 months after FMT). The study lists 2 primary outcomes in all. 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 NCT02299973, which also lists 5 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 8 Dec 2017.