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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Teemu T Puodinketo, MD contact

+35823139427

teemu.puodinketo@tyks.fi

Kimmo Salminen, MD contact

+35823130691

kimmo.salminen@tyks.fi

Finland3 sites, 3 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

    Recruiting

Other trials in Finland

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 groups in NCT05874830
Study groupRoleWhat they receive
FMT through colonoscopyActive comparatorPatient gets FMT in ceacum and plasebo in duodenum.
Receives: Other: Fecal microbiota transplant or plasebo through endoscopy
FMT through duodenogastroscopyActive comparatorPatient gets plasebo in ceacum and FMT in duodenum.
Receives: Other: Fecal microbiota transplant or plasebo through endoscopy
PlaseboPlacebo comparatorPatient 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.

  1. 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)
  1. 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

  2. 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.

  3. 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

  4. 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.

  1. First posted25 May 2023
  2. Study start15 Oct 2021
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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)
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

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.

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