Clinical trial NCT05874830: The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Official title: The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Microbial Substitution
Keywords: IBS
FMT
Fecal microbiota transplant
microbiome
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded plasebo controlled study with two treatment cohorts and one plasebo cohort
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor.
timeFrame: Microbiota is tested at prescreening visit, at the baseline and in 4, 12 and 52 weeks after FMT-procedure.
Secondary outcomes:
measure: The main clinical outcome is reduction of abdominal pain three months after FMT.
timeFrame: 3 months
measure: GI Symptoms: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)
timeFrame: in 3 months and in 1 year points compared to baseline.
measure: Mood, General Anxiety-Disorder 7 - questionnaire
timeFrame: The change in the score of questionnaires between the baseline at 3 months and 12 months
measure: Mood, Beck's Depression Inventory.
timeFrame: The change in the score of questionnaires between the baseline at 3 months and 12 months
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed
timeFrame: through study completion, an average of 1 year
measure: Broadening of diet
timeFrame: before intervention and after 3 months.
Locations:
city: Lahti
country: Finland
facility: Central hospital of Päijät-Häme
state: Paijat-Hame
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
city: Turku
country: Finland
facility: Turku university hospital
state: Varsinais-Suomi
Study officials:
References: