Fecal Microbiota Transplantation for Irritable Bowel Synd... | NCT05361785

Studies
Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

NCT05361785

Sponsor

Helsinki University Central Hospital

Status

Recruiting

Last Update Posted

May 13, 2022Actual

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome
Fecal Microbiota Transplantation

Interventions

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2022Actual

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Apr 30, 2022

First Submission Date that Met QC Criteria

Apr 30, 2022

First Posted Date

May 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2022

Last Update Posted Date

May 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Perttu Arkkila, Professor, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Name	Class
Turku University Hospital	OTHER_GOV
University of Helsinki	OTHER
Paijat-Hame Hospital District	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown.

The purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.

Detailed Description

This is a plasebo controlled study in which we study the effect and safety of FMT in patients who have IBS and have used FODMAP diet. FMT is assessed by colonoscopy route and therafter the patietns receive twice FMT enema from healthy donor or plasebo..

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMT form healthy donor	Active Comparator	FMT from healthy donor	Biological: FMT
FMT plasebo	Placebo Comparator	FMT plasebo	Biological: FMT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FMT	Biological	FMT from healthy donor or placebo	FMT form healthy donor FMT plasebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effect of FMT for tolerance of FODMAPs in the IBS patients' diet	With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet.	FMT and IBS

Secondary Outcomes

Measure	Description	Time Frame
Microbial components explaining the successful broadening of FODMAP diet in IBS patients.	We aim to investigate what are the microbial components explaining the successful broadening of their diet and identify microbial taxa engrafted from the donor explaining the dietary modifications.	Microbiome and FODMAP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults, age 18-75 years, knowledge of the Finnish language
IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial
The patient must consume low FODMAP diet to control IBS symptoms
Patient must sign the informed consent

Exclusion Criteria:

Diagnosed allergies to food components in the study dietary protocol
Pregnancy and breastfeeding
Antibiotic treatment less than three months prior enrolment
Faecal incontinence, i.e., inability to retain enema
Abuse of drugs, alcohol or medications
Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea.
Severe psychiatric or neurologic condition decreasing patient's compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Perttu Arkkila, Professor	Contact	+358504272272	+35894	perttu.arkkila@hus.fi
Perttu Lahtinen, Md	Contact	+358381911	+35838192323	perttu.lahtinen@phhyky.fi

Overall Officials

Name	Affiliation	Role
Perttu Arkkila, Professor	Head physician	Principal Investigator
Perttu Lahtinen, Md.	Head physician	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital	Recruiting	Helsinki	Helsinki and Uusimaa	00290	Finland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Pseudoanonymous data is available to other reserchers

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

31 July 2025 for one yrear.

Access Criteria

Scientific work

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided