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The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Primary Purpose

IBS - Irritable Bowel Syndrome, Microbial Substitution

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fecal microbiota transplant or plasebo through endoscopy
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome focused on measuring IBS, FMT, Fecal microbiota transplant, microbiome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Central hospital of Päijät-HämeRecruiting
  • Helsinki University HospitalRecruiting
  • Turku university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

FMT through colonoscopy

FMT through duodenogastroscopy

Plasebo

Arm Description

Patient gets FMT in ceacum and plasebo in duodenum.

Patient gets plasebo in ceacum and FMT in duodenum.

Patient gets plasebo in colonoscopy and in gastroscopy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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"
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.
Mood, General Anxiety-Disorder 7 - questionnaire
Mood changes in GAD -questionnaire. Aim is to lower the score in GAD-7 questionnaire.
Mood, Beck's Depression Inventory.
Mood changes in BDI -questionnaire. Score from 0-60. Aiming to lower the score in BDI-questionnaire.

Full Information

First Posted
April 17, 2022
Last Updated
May 22, 2023
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05874830
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome, Microbial Substitution
Keywords
IBS, FMT, Fecal microbiota transplant, microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded plasebo controlled study with two treatment cohorts and one plasebo cohort
Masking
ParticipantCare ProviderInvestigator
Masking Description
The patient and the endoscopists are blinded when the FMT/plasebo is given
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT through colonoscopy
Arm Type
Active Comparator
Arm Description
Patient gets FMT in ceacum and plasebo in duodenum.
Arm Title
FMT through duodenogastroscopy
Arm Type
Active Comparator
Arm Description
Patient gets plasebo in ceacum and FMT in duodenum.
Arm Title
Plasebo
Arm Type
Placebo Comparator
Arm Description
Patient gets plasebo in colonoscopy and in gastroscopy.
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplant or plasebo through endoscopy
Intervention Description
Colonoscopy and gastroscopy
Primary Outcome Measure Information:
Title
Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor.
Description
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.
Time Frame
Microbiota is tested at prescreening visit, at the baseline and in 4, 12 and 52 weeks after FMT-procedure.
Secondary Outcome Measure Information:
Title
The main clinical outcome is reduction of abdominal pain three months after FMT.
Description
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"
Time Frame
3 months
Title
GI Symptoms: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)
Description
Change in symptoms in GSRS questionnaire. Scale from 0 to 90, lower the score better the outcome.
Time Frame
in 3 months and in 1 year points compared to baseline.
Title
Mood, General Anxiety-Disorder 7 - questionnaire
Description
Mood changes in GAD -questionnaire. Aim is to lower the score in GAD-7 questionnaire.
Time Frame
The change in the score of questionnaires between the baseline at 3 months and 12 months
Title
Mood, Beck's Depression Inventory.
Description
Mood changes in BDI -questionnaire. Score from 0-60. Aiming to lower the score in BDI-questionnaire.
Time Frame
The change in the score of questionnaires between the baseline at 3 months and 12 months
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events as assessed
Description
Safety 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.
Time Frame
through study completion, an average of 1 year
Title
Broadening of diet
Description
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.
Time Frame
before intervention and after 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teemu T Puodinketo, MD
Phone
+35823139427
Email
teemu.puodinketo@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Kimmo Salminen, MD
Phone
+35823130691
Email
kimmo.salminen@tyks.fi
Facility Information:
Facility Name
Central hospital of Päijät-Häme
City
Lahti
State/Province
Paijat-Hame
ZIP/Postal Code
15850
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perttu Lahtinen, MD
Email
perttu.lahtinen@phhyky.fi
Facility Name
Helsinki University Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perttu Arkkila, Professor
Email
perttu.arkkila@hus.fi
Facility Name
Turku university hospital
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teemu P Puodinketo, MD
Phone
+35823139427
Email
teemu.puodinketo@tyks.fi
First Name & Middle Initial & Last Name & Degree
Kimmo Salminen, MD
Phone
+35823130691
Email
kimmo.salminen@tyks.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

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