Irritable Bowel Syndrome With DiarrheaMISCEATNCT04899869
Faecal Microbiota Transplantation in Irritable Bowel Syndrome
A study testing Faecal microbiota transplantation with active study microbiota first, Faecal microbiota transplantation with inactive autoclaved study microbiota first and Faecal microbiota transplantation with inactive autoclaved study microbiota only in people with Irritable Bowel Syndrome With Diarrhea and Irritable Bowel Syndrome Mixed, run by Thomayer University Hospital at 1 site in Czechia.
Trial summary
Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome Mixed
- What is being tested?
- Faecal microbiota transplantation with active study microbiota first, Faecal microbiota transplantation with inactive autoclaved study microbiota first and Faecal microbiota transplantation with inactive autoclaved study microbiota only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Jun 2021to 29 Apr 2024
- 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
- Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) or Irritable Bowel Syndrome with mixed bowel habits (IBS-M) according to the Rome IV criteria
Who cannot join
- The use of antibiotics within one month prior to faecal microbiota transplantation
- The use of probiotics within one month prior to faecal microbiota transplantation
- History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)
- Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)
- HIV infection or other active infection
- Renal or hepatic disease (both defined by biochemistry workup)
Show all 10Show fewer
- Diabetes mellitus, abnormal thyroid functions not controlled by thyroid medications
- Bipolar disorder or schizophrenia (ongoing or history thereof), moderately severe depression defined by Patient Health Questionnaire-9 (PHQ-9) score > 15
- Anxiety defined by a Generalised Anxiety Disorder 7 (GAD7) score > 10
- Current pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Faecal Microbiota Transplantation in Irritable Bowel Syndrome: a Randomised, Double-blind Cross-over Study Utilising Mixed Microbiota From Healthy Donors
Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.
Read the detailed description
Three-groups, double-blind, placebo-controlled, randomised, cross-over study in adult patients diagnosed with IBS (diarrhoeal or mixed form) according to Rome IV criteria. Each study subject will undergo two pairs of faecal microbiota transplantation (a total of four enemas for each patient), with the pairs of transfers being eight weeks apart. The active intervention substance is a mixed stool microbiota derived from healthy individuals, screened for infectious diseases according to European consensus conference on faecal microbiota transplantation guidelines, and who were preselected for high alpha diversity of their microbiome and distance in community ordination from IBS patients microbiota. Placebo is the same mixture, inactivated by autoclaving.
- Being tested
- Faecal microbiota transplantation with active study microbiota first, Faecal microbiota transplantation with inactive autoclaved study microbiota first, Faecal microbiota transplantation with inactive autoclaved study microbiota only
- Keywords
- IBS - D, IBS - M
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal microbiota transplantation with active study microbiota firstOther
2x enema with active study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota
Faecal microbiota transplantation with inactive autoclaved study microbiota firstOther
2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with active study microbiota
Faecal microbiota transplantation with inactive autoclaved study microbiota onlyOther
2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota
| Study group | Role | What they receive |
|---|---|---|
| Group A (active microbiota first) | Other | Patients will first receive two enemas of active study microbiota mixture (deep-frozen stored stool microbiota mixed from eight donors in order to increase its diversity), then after eight weeks they will receive two enemas with placebo. Receives: Other: Faecal microbiota transplantation with active study microbiota first |
| Group B (inactive microbiota first) | Other | Patients will first receive placebo, then the active study microbiota mixture. Receives: Other: Faecal microbiota transplantation with inactive autoclaved study microbiota first |
| Group C (inactive microbiota only) | Other | Patients will receive similarly timed enemas with placebos only. Receives: Other: Faecal microbiota transplantation with inactive autoclaved study microbiota only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the IBS severity symptom score (IBS-SSS)
Change in the IBS severity symptom score (IBS-SSS) in the active microbiota group relative to the placebo group.
Measured: The difference between the score at four weeks after the intervention (study weeks 5 or 13, respectively) and the baseline score (week -1 in 'Active microbiota first' group or week 8 in 'Inactive microbiota first' group)
Secondary outcomes (14)
The acute change in the IBS severity symptom score (IBS-SSS)
IBS-SSS between baseline and two weeks after intervention
Measured: study weeks 3 and 11, respectively
The long-term change in the IBS severity symptom score (IBS-SSS)
IBS-SSS between baseline (week -1) and week 32. The long term change will compare placebo group to merged active study microbiota groups.
Measured: baseline and study week 32
Change in number of loose stools per day
Change in number of loose stools per day in the active microbiota group relative to the placebo group
Measured: baseline and study week 32
Change in stool consistency
Change in stool consistency evaluated by Bristol stool scale (type 3 and 4 - normal; types 1,2,5,6 and 7 - abnormal) in the active microbiota group relative to the placebo group
Measured: baseline and study week 32
Change in abdominal pain
Change in abdominal pain measured by Visual Analogue Scale (VAS) (0 - no pain, 10 - worst pain) in the active microbiota group relative to the placebo group
Measured: baseline and study week 32
Change in frequency of bloating per week
Change in frequency of bloating per week (as there is no standardised measurement, it will be reported as number of episodes per time unit, where the possible answers could be: no bloating, bloating once a week, twice a week, three times a week, four times a week, five times a week, six times a week, bloating daily, bloating daily and sometimes at night, bloating more than half of days, bloating continuously) in the active microbiota group relative to the placebo group
Measured: baseline and study week 32
Change in Body Mass Index
Change in Body Mass Index (BMI in kg/m^2) in the active microbiota group relative to the placebo group
Measured: baseline and study week 32
Change in waist circumference
Change in waist circumference (in centimeters) in the active microbiota group relative to the placebo group
Measured: baseline and study week 32
Change in body fat mass estimated by skinfold thickness measuring
Change in body fat mass estimated by measuring combined skinfold thickness at given locations (biceps, triceps, subscapular, suprailiac) in millimetres in the active microbiota group relative to the placebo group
Measured: baseline and study week 32
Change in body fat mass measured by bioelectrical impedance analysis
Change in body fat mass in the active microbiota group relative to the placebo group measured by bioelectrical impedance analysis (in %)
Measured: baseline and study week 32
Change in faecal microbiome's alpha (within-sample) diversity
Change in faecal microbiome's alpha (within-sample) diversity in the active microbiota group relative to the placebo group measured by Chao index of alpha diversity (higher value means higher alpha-diversity)
Measured: baseline and study week 32
Change in faecal microbiome's beta (between samples) diversity
Change in faecal microbiome's beta (between samples) diversity in the active microbiota group relative to the placebo group assessed by the quantitative Bray-Curtis index (more distant means more different bacterial composition) ordinated by nonmetric multidimensional scaling (NMDS)
Measured: baseline and study week 32
Change in the quantity of single-cell protist Blastocystis
Change in the quantity of single-cell protist Blastocystis in the active microbiota group relative to the placebo group assessed by a specific quantitative polymerase chain reaction assay measured in genomic equivalents per microlitre DNA (the higher concentration means more of Blastocystis)
Measured: baseline and study week 32
The psychological and well-being effects of the therapy (IBS-QoL)
The psychological and well-being effects of the therapy scored by IBS-QoL questionnaires
Measured: baseline and study week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start17 Jun 2021
- Primary completion27 Mar 2024
- Study completion29 Apr 2024
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 Syndrome With DiarrheaStudies 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
- Crossover
- Model description
- Each study subject will undergo two pairs of faecal microbiota transplantation eight weeks apart (a total of four enemas for each patient). Our study design has several specific features: (a) Two consecutive transfers were designed to improve study microbiota engraftment. Before the first of every transfer pairs, the subjects will receive a reduced dose of oral polyethylene glycol for partial bowel preparation. (b) To help discern potential carry-over effects, a placebo-only group was included; this also enables us to assess long-term effects of the intervention. (c) The transferred microbiota is identical throughout the study, having been mixed beforehand, aliquoted and deep frozen. Its alpha diversity was artificially increased by mixing stools from several donors. (d) Placebo is made of the same mixture by careful autoclaving.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomayer University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Principal investigator, Pavel Kohout, Thomayer University Hospital
- Investigators
- Pavel Kohout, Principal investigator, Thomayer University Hospital, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899869
- Sponsor's protocol ID
- INT_TN_001
- Acronym
- MISCEAT
- Status last verified
- May 2024
- First submitted
- 19 May 2021
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only the researchers involved in the study have access to the final study dataset (IBS-SSS, frequency of urgent defecations, Bristol stool scale, abdominal pain and bloating), which will be shared in an anonymised form via the Zenodo repository.
Publications
Hurych J, Vejmelka J, Hlinakova L, Kramna L, Larionov V, Kulich M, Cinek O, Kohout P. Protocol for faecal microbiota transplantation in irritable bowel syndrome: the MISCEAT study - a randomised, double-blind cross-over study using mixed microbiota from healthy donors. BMJ Open. 2022 Jun 27;12(6):e056594. doi: 10.1136/bmjopen-2021-056594.
PubMed 35760542
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation in Irritable Bowel Syndrome: a Randomised, Double-blind Cross-over Study Utilising Mixed Microbiota From Healthy Donors
- ClinicalTrials.gov ID
- NCT04899869
- Acronym / sponsor ID
- MISCEAT / INT_TN_001
- Keywords
- IBS - D, IBS - M
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Thomayer University HospitalUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 25 May 2021 (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.
Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.
Detailed description
Three-groups, double-blind, placebo-controlled, randomised, cross-over study in adult patients diagnosed with IBS (diarrhoeal or mixed form) according to Rome IV criteria. Each study subject will undergo two pairs of faecal microbiota transplantation (a total of four enemas for each patient), with the pairs of transfers being eight weeks apart. The active intervention substance is a mixed stool microbiota derived from healthy individuals, screened for infectious diseases according to European consensus conference on faecal microbiota transplantation guidelines, and who were preselected for high alpha diversity of their microbiome and distance in community ordination from IBS patients microbiota. Placebo is the same mixture, inactivated by autoclaving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Each study subject will undergo two pairs of faecal microbiota transplantation eight weeks apart (a total of four enemas for each patient). Our study design has several specific features: (a) Two consecutive transfers were designed to improve study microbiota engraftment. Before the first of every transfer pairs, the subjects will receive a reduced dose of oral polyethylene glycol for partial bowel preparation. (b) To help discern potential carry-over effects, a placebo-only group was included; this also enables us to assess long-term effects of the intervention. (c) The transferred microbiota is identical throughout the study, having been mixed beforehand, aliquoted and deep frozen. Its alpha diversity was artificially increased by mixing stools from several donors. (d) Placebo is made of the same mixture by careful autoclaving.
| Arm | Type | Receives |
|---|---|---|
| Group A (active microbiota first) | Other | Other: Faecal microbiota transplantation with active study microbiota firstPatients will first receive two enemas of active study microbiota mixture (deep-frozen stored stool microbiota mixed from eight donors in order to increase its diversity), then after eight weeks they will receive two enemas with placebo. |
| Group B (inactive microbiota first) | Other | Other: Faecal microbiota transplantation with inactive autoclaved study microbiota firstPatients will first receive placebo, then the active study microbiota mixture. |
| Group C (inactive microbiota only) | Other | Other: Faecal microbiota transplantation with inactive autoclaved study microbiota onlyPatients will receive similarly timed enemas with placebos only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) or Irritable Bowel Syndrome with mixed bowel habits (IBS-M) according to the Rome IV criteria
Key exclusion criteria (10 listed)
- The use of antibiotics within one month prior to faecal microbiota transplantation
- The use of probiotics within one month prior to faecal microbiota transplantation
- History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)
- Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)
- HIV infection or other active infection
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 |
|---|---|---|
| Faecal microbiota transplantation with active study microbiota first2x enema with active study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota | Other | Group A (active microbiota first) |
| Faecal microbiota transplantation with inactive autoclaved study microbiota first2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with active study microbiota | Other | Group B (inactive microbiota first) |
| Faecal microbiota transplantation with inactive autoclaved study microbiota only2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota | Other | Group C (inactive microbiota only) |
Primary outcome
Change in the IBS severity symptom score (IBS-SSS)
Time frame: The difference between the score at four weeks after the intervention (study weeks 5 or 13, respectively) and the baseline score (week -1 in 'Active microbiota first' group or week 8 in 'Inactive microbiota first' group)
Change in the IBS severity symptom score (IBS-SSS) in the active microbiota group relative to the placebo group.
14 secondary outcomes
The acute change in the IBS severity symptom score (IBS-SSS)
Time frame: study weeks 3 and 11, respectively
The long-term change in the IBS severity symptom score (IBS-SSS)
Time frame: baseline and study week 32
Change in number of loose stools per day
Time frame: baseline and study week 32
Change in stool consistency
Time frame: baseline and study week 32
Change in abdominal pain
Time frame: baseline and study week 32
Change in frequency of bloating per week
Time frame: baseline and study week 32
Change in Body Mass Index
Time frame: baseline and study week 32
Change in waist circumference
Time frame: baseline and study week 32
Change in body fat mass estimated by skinfold thickness measuring
Time frame: baseline and study week 32
Change in body fat mass measured by bioelectrical impedance analysis
Time frame: baseline and study week 32
Change in faecal microbiome's alpha (within-sample) diversity
Time frame: baseline and study week 32
Change in faecal microbiome's beta (between samples) diversity
Time frame: baseline and study week 32
Change in the quantity of single-cell protist Blastocystis
Time frame: baseline and study week 32
The psychological and well-being effects of the therapy (IBS-QoL)
Time frame: baseline and study week 32
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 24 May 2024.
- Derived from this study: PubMed 35760542Hurych J, Vejmelka J, Hlinakova L, Kramna L, Larionov V, Kulich M, Cinek O, Kohout P. Protocol for faecal microbiota transplantation in irritable bowel syndrome: the MISCEAT study - a randomised, double-blind cross-over study using mixed microbiota from healthy donors. BMJ Open. 2022 Jun 27;12(6):e056594. doi: 10.1136/bmjopen-2021-056594.
- Individual participant dataSharing planned: Yes. Only the researchers involved in the study have access to the final study dataset (IBS-SSS, frequency of urgent defecations, Bristol stool scale, abdominal pain and bloating), which will be shared in an anonymised form via the Zenodo repository.
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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.
Pavel Kohout principal investigator
Thomayer University Hospital, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal microbiota transplantation with active study microbiota first, Faecal microbiota transplantation with inactive autoclaved study microbiota first and Faecal microbiota transplantation with inactive autoclaved study microbiota only in people with Irritable Bowel Syndrome With Diarrhea and Irritable Bowel Syndrome Mixed, run by Thomayer University Hospital at 1 site in Czechia.
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 1 inclusion and 10 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 24 May 2024. 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 Czechia. 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?
Change in the IBS severity symptom score (IBS-SSS) (time frame: The difference between the score at four weeks after the intervention (study weeks 5 or 13, respectively) and the baseline score (week -1 in 'Active microbiota first' group or week 8 in 'Inactive microbiota first' group)). 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 NCT04899869, 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 24 May 2024.