IBS - Irritable Bowel SyndromeNCT05874830
The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
A study testing Fecal microbiota transplant or plasebo through endoscopy in people with IBS - Irritable Bowel Syndrome and Microbial Substitution, run by Turku University Hospital at 3 sites in Finland.
Trial summary
The object of this study is to find out is there an optimal route for the fecal microbiata transplant (FMT) in patients that suffer from irritable bowel syndrome. The investigators compare outcomes in patients with repeated fecal microbiome samples and make symptomatic questionnaires (i.e. 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, Microbial Substitution
- What is being tested?
- Fecal microbiota transplant or plasebo through endoscopy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesFinland
- Study dates
- 15 Oct 2021to 1 Dec 2025
- 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
- Adult
- 18-70 years
- known of Finnish language
- IBS, (new or old diagnosis according to Roma III or IV criteria), all subtypes
- Informed consent
- Moderate to severe IBS symptoms, IBS-SSS > 175
Who cannot join
- Pregnancy
- Antibiotic or probiotic treatment, on-going or previous month
- Abuse of drugs, alcohol or medications
- Other diagnosis besides IBS causing the GI symptoms, such as IBD, microscopic colitis or bile acid diarrhea
Trial locations and contacts
3 sites in 1 country.
Finland3 sites, 3 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, Uusimaa, 00029
Perttu Arkkila, Professor, perttu.arkkila@hus.fi
- Recruiting
Central hospital of Päijät-Häme
Lahti, Paijat-Hame Region, 15850
Perttu Lahtinen, MD, perttu.lahtinen@phhyky.fi
- Recruiting
Turku university hospital
Turku, Southwest Finland, 20520
Teemu P Puodinketo, MD, +35823139427, teemu.puodinketo@tyks.fi
Kimmo Salminen, MD, +35823130691, kimmo.salminen@tyks.fi
About this study
The object of this study is to find out is there an optimal route for the fecal microbiata transplant (FMT) in patients that suffer from irritable bowel syndrome. The investigators compare outcomes in patients with repeated fecal microbiome samples and make symptomatic questionnaires (i.e. IBS-SSS, GSRS) to find out if there is difference in severity of symptoms compared to FMT given in duodenogastroscopy or in coloscopy.
Read the detailed description
Irritable bowel syndrome (IBS) is a common functional disorder affecting approximately 10% globally.[1] It is often referred to as benign, although, when severe, may cause significant reduction of quality of life and work absenteeism. The etiology of IBS is unknown although many theories have been proposed. Altered gut motility, epithelial hyperpermeability, low grade inflammation, visceral hypersensitivity, epigenetics and genetics, altered gut-brain interaction and psychological stressors have all been reported in patients with IBS.
Several studies have detected alterations in the gut microbiota composition between IBS patients and healthy controls, however a microbiota typical for IBS patients has not been conclusively defined.
Fecal microbiota transplantation has over 90% efficace in recurrent Clostridioides difficile infection (rCDI), for which it has been in clinical use for a decade. FMT is currently recommended after the second relapse of rCDI. FMT is recommended to be considered only in clinical trial settings for other indications than rCDI.
Randomized controlled studies in FMT for IBS have conflicting results. In studies with a single administration of FMT in colonoscopy a mild transient reduction of IBS symptoms has followed the intervention. In studies with fecal capsules there has not been any benefit observed. FMT via gastroscopy exerted a clear benefit with an up to 89.1% response rate. These surprisingly good results were thought to be contributable to careful donor selection, however the study included only one donor and no specific characteristics of microbiota were indentified of the suspected superdonor. Although all these three administration routes altered the microbiota of IBS patients towards that of the donor, a concurrent decrease in the symptoms was observed only when FMT was administered via colonoscopy or gastroscopy.
Manipulation of microbiota through FMT remains to be potential treatment option for IBS, however, several mechanistic questions await answering. Investigators do not yet know what is the component of stool which would carry the healing potential. There needs to be further research to define optimal donors as well as optimal patients who would be prone to benefit of FMT. The amount and number of FMT treatments may be a factor contributing to the outcome.
It is also undefined in which extend does the route of administration of FMT contribute to the outcome in IBS patients. Therefore, the investigators present a placebo-controlled trial "the optimal route" to provide further mechanistic knowledge of the optimal FMT protocol in this patient group.
- Being tested
- Fecal microbiota transplant or plasebo through endoscopy
- Keywords
- IBS, FMT, Fecal microbiota transplant, microbiome
- 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 microbiota transplant or plasebo through endoscopyOther
Colonoscopy and gastroscopy
| Study group | Role | What they receive |
|---|---|---|
| FMT through colonoscopy | Active comparator | Patient gets FMT in ceacum and plasebo in duodenum. Receives: Other: Fecal microbiota transplant or plasebo through endoscopy |
| FMT through duodenogastroscopy | Active comparator | Patient gets plasebo in ceacum and FMT in duodenum. Receives: Other: Fecal microbiota transplant or plasebo through endoscopy |
| Plasebo | Placebo comparator | Patient gets plasebo in colonoscopy and in gastroscopy. Receives: Other: Fecal microbiota transplant or plasebo through endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor.
The changes in the engraftment of specific bacteria between the active groups is of special interest, and the changes in the microbiota during the whole of study in the intervention group and in the plasebo group.
Measured: Microbiota is tested at prescreening visit, at the baseline and in 4, 12 and 52 weeks after FMT-procedure.
Secondary outcomes (4)
The main clinical outcome is reduction of abdominal pain three months after FMT.
Gut pain: "Has your abdominal pain reduced after the intervention? "Broadening of diet: "Have you been able expand your diet after the intervention?" Global IBS symptoms: "reduction of IBS-SSS total score 50 points or more from the baseline value"
Measured: 3 months
GI Symptoms: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)
Change in symptoms in GSRS questionnaire. Scale from 0 to 90, lower the score better the outcome.
Measured: in 3 months and in 1 year points compared to baseline.
Mood, General Anxiety-Disorder 7 - questionnaire
Mood changes in GAD -questionnaire. Aim is to lower the score in GAD-7 questionnaire.
Measured: The change in the score of questionnaires between the baseline at 3 months and 12 months
Mood, Beck's Depression Inventory.
Mood changes in BDI -questionnaire. Score from 0-60. Aiming to lower the score in BDI-questionnaire.
Measured: The change in the score of questionnaires between the baseline at 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 Oct 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Turku 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded plasebo controlled study with two treatment cohorts and one plasebo cohort
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kimmo Salminen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874830
- Sponsor's protocol ID
- T109/2021
- Status last verified
- May 2023
- First submitted
- 17 Apr 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05874830
- Acronym / sponsor ID
- T109/2021
- Keywords
- IBS, FMT, Fecal microbiota transplant, microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 May 2023 (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 object of this study is to find out is there an optimal route for the fecal microbiata transplant (FMT) in patients that suffer from irritable bowel syndrome. The investigators compare outcomes in patients with repeated fecal microbiome samples and make symptomatic questionnaires (i.e. IBS-SSS, GSRS) to find out if there is difference in severity of symptoms compared to FMT given in duodenogastroscopy or in coloscopy.
Detailed description
Irritable bowel syndrome (IBS) is a common functional disorder affecting approximately 10% globally.[1] It is often referred to as benign, although, when severe, may cause significant reduction of quality of life and work absenteeism. The etiology of IBS is unknown although many theories have been proposed. Altered gut motility, epithelial hyperpermeability, low grade inflammation, visceral hypersensitivity, epigenetics and genetics, altered gut-brain interaction and psychological stressors have all been reported in patients with IBS.
Several studies have detected alterations in the gut microbiota composition between IBS patients and healthy controls, however a microbiota typical for IBS patients has not been conclusively defined.
Fecal microbiota transplantation has over 90% efficace in recurrent Clostridioides difficile infection (rCDI), for which it has been in clinical use for a decade. FMT is currently recommended after the second relapse of rCDI. FMT is recommended to be considered only in clinical trial settings for other indications than rCDI.
Randomized controlled studies in FMT for IBS have conflicting results. In studies with a single administration of FMT in colonoscopy a mild transient reduction of IBS symptoms has followed the intervention. In studies with fecal capsules there has not been any benefit observed. FMT via gastroscopy exerted a clear benefit with an up to 89.1% response rate. These surprisingly good results were thought to be contributable to careful donor selection, however the study included only one donor and no specific characteristics of microbiota were indentified of the suspected superdonor. Although all these three administration routes altered the microbiota of IBS patients towards that of the donor, a concurrent decrease in the symptoms was observed only when FMT was administered via colonoscopy or gastroscopy.
Manipulation of microbiota through FMT remains to be potential treatment option for IBS, however, several mechanistic questions await answering. Investigators do not yet know what is the component of stool which would carry the healing potential. There needs to be further research to define optimal donors as well as optimal patients who would be prone to benefit of FMT. The amount and number of FMT treatments may be a factor contributing to the outcome.
It is also undefined in which extend does the route of administration of FMT contribute to the outcome in IBS patients. Therefore, the investigators present a placebo-controlled trial "the optimal route" to provide further mechanistic knowledge of the optimal FMT protocol in this patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Double blinded plasebo controlled study with two treatment cohorts and one plasebo cohort
| Arm | Type | Receives |
|---|---|---|
| FMT through colonoscopy | Active comparator | Other: Fecal microbiota transplant or plasebo through endoscopyPatient gets FMT in ceacum and plasebo in duodenum. |
| FMT through duodenogastroscopy | Active comparator | Other: Fecal microbiota transplant or plasebo through endoscopyPatient gets plasebo in ceacum and FMT in duodenum. |
| Plasebo | Placebo comparator | Other: Fecal microbiota transplant or plasebo through endoscopyPatient gets plasebo in colonoscopy and in gastroscopy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult
- 18-70 years
- known of Finnish language
- IBS, (new or old diagnosis according to Roma III or IV criteria), all subtypes
- Informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Antibiotic or probiotic treatment, on-going or previous month
- Abuse of drugs, alcohol or medications
- Other diagnosis besides IBS causing the GI symptoms, such as IBD, microscopic colitis or bile acid diarrhea
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 microbiota transplant or plasebo through endoscopyColonoscopy and gastroscopy | Other | FMT through colonoscopy, FMT through duodenogastroscopy, Plasebo |
Primary outcome
Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor.
Time frame: Microbiota is tested at prescreening visit, at the baseline and in 4, 12 and 52 weeks after FMT-procedure.
The changes in the engraftment of specific bacteria between the active groups is of special interest, and the changes in the microbiota during the whole of study in the intervention group and in the plasebo group.
4 secondary outcomes
The main clinical outcome is reduction of abdominal pain three months after FMT.
Time frame: 3 months
GI Symptoms: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)
Time frame: in 3 months and in 1 year points compared to baseline.
Mood, General Anxiety-Disorder 7 - questionnaire
Time frame: The change in the score of questionnaires between the baseline at 3 months and 12 months
Mood, Beck's Depression Inventory.
Time frame: The change in the score of questionnaires between the baseline at 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
Related trials for IBS - 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplant or plasebo through endoscopy in people with IBS - Irritable Bowel Syndrome and Microbial Substitution, run by Turku University Hospital at 3 sites in Finland.
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 4 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: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teemu T Puodinketo, MD (+35823139427, teemu.puodinketo@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor. (time frame: Microbiota is tested at prescreening visit, at the baseline and in 4, 12 and 52 weeks after FMT-procedure.). 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 25 May 2023.