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The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05874830
Enrollment
36
Registered
2023-05-25
Start date
2021-10-15
Completion date
2025-12-01
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS - Irritable Bowel Syndrome, Microbial Substitution

Keywords

IBS, FMT, Fecal microbiota transplant, microbiome

Brief 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. 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.

Interventions

OTHERFecal microbiota transplant or plasebo through endoscopy

Colonoscopy and gastroscopy

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

The patient and the endoscopists are blinded when the FMT/plasebo is given

Intervention model description

Double blinded plasebo controlled study with two treatment cohorts and one plasebo cohort

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor.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.

Secondary

MeasureTime frameDescription
The main clinical outcome is reduction of abdominal pain three months after FMT.3 monthsGut 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
GI Symptoms: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)in 3 months and in 1 year points compared to baseline.Change in symptoms in GSRS questionnaire. Scale from 0 to 90, lower the score better the outcome.
Mood, General Anxiety-Disorder 7 - questionnaireThe change in the score of questionnaires between the baseline at 3 months and 12 monthsMood changes in GAD -questionnaire. Aim is to lower the score in GAD-7 questionnaire.
Mood, Beck's Depression Inventory.The change in the score of questionnaires between the baseline at 3 months and 12 monthsMood changes in BDI -questionnaire. Score from 0-60. Aiming to lower the score in BDI-questionnaire.

Other

MeasureTime frameDescription
Incidence of Treatment-Emergent Adverse Events as assessedthrough study completion, an average of 1 yearSafety of FMT and endoscopic procedures, is there complications that need hospitalisation or other medical intervention for patients. Results given in numbers and differentiated between major and minor complications.
Broadening of dietbefore intervention and after 3 months.D2D-questionnaire, that gives an overall index-value of how healthy subjects diet is, higher the value, healthier the diet.The D2D questionnaire gives on index-value from 0-100.

Countries

Finland

Contacts

Primary ContactTeemu T Puodinketo, MD
teemu.puodinketo@tyks.fi+35823139427
Backup ContactKimmo Salminen, MD
kimmo.salminen@tyks.fi+35823130691

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026