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Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) (AMIRA)

Primary Purpose

Diarrhea-predominant Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Allogeneic microbiota reconstitution
Placebo-Allogeneic microbiota reconstitution
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea-predominant Irritable Bowel Syndrome focused on measuring Allogeneic microbiota reconstitution, diarrhea-predominant irritable bowel syndrome, microbiome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • written informed consent
  • irritable bowel syndrome of diarrhea-predominant type according to ROME III criteria
  • Symptoms for > 1 year before study inclusion
  • persisting symptoms > 1 year before study inclusion
  • relevant symptoms with reduced Quality of Life (IBS-QOL < 60 Points)
  • no specific findings in gastroscopy and colonoscopy with biopsies in the last 2 years

Exclusion Criteria:

  • chronic inflammatory diseases
  • gastrointestinal infectious diseases
  • microscopic colitis
  • celiac disease
  • diarrhea caused by fructose- or lactose intolerance
  • gastrointestinal malignancies or intestinal polyps
  • irritable bowel syndrome of other type than IBS-D
  • bile acid diarrhea
  • constipation
  • symptoms caused by other diseases than IBS-D
  • dementia
  • abdominal surgery in the last months
  • antibiotic therapy in the last 3 months
  • pregnancy
  • linguistic barrier for informed consent

Sites / Locations

  • Helios Klinikum Krefeld
  • Ulm University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum-AMR

Placebo-AMR

Arm Description

Patients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy

Patients receiving Placebo(Saline)-Infusion via gastroscopy

Outcomes

Primary Outcome Measures

Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline

Secondary Outcome Measures

Improvement of IBS-QOL using IBS-QOL-questionnaire compared to baseline
Changes and acceptance of donor microbiome (16S rDNA-analysis)
16S rDNA-analysis for microbiome biodiversity, correlation to IBS-Symptom Severity Score (IBS-SSS)
Number of participants with treatment related adverse events

Full Information

First Posted
June 14, 2016
Last Updated
January 30, 2020
Sponsor
University of Ulm
Collaborators
Klinikum Ludwigsburg, Helios Klinikum Krefeld, Charite University, Berlin, Germany, Assign International, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04095988
Brief Title
Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Acronym
AMIRA
Official Title
Allogeneic Microbiota-reconstitution (AMR) for the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome - the AMIRA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
Collaborators
Klinikum Ludwigsburg, Helios Klinikum Krefeld, Charite University, Berlin, Germany, Assign International, Berlin, Germany

4. Oversight

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

5. Study Description

Brief Summary
The investigators will perform a multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with diarrhea predominant-IBS (IBS-D) diagnosed according to Rome III criteria and the IBS-QOL questionnaire. Central supply and quality control of donor material will be used to control bias. Primary endpoint is improvement of IBS-SSS (Severity Score System) compared to baseline. Secondary endpoints include changes in IBS-QOL, short term safety and one year follow up to control long term effects, safety and changes in and acceptance of donor microbiome after AMR using16S rDNA sequencing and quantitative diversity analysis.
Detailed Description
This study assesses allogeneic microbiota reconstitution (AMR) as novel treatment to improve symptoms and quality of life of patients with diarrhea-predominant irritable bowel syndrome (IBS-D). The investigators will perform a prospective multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with IBS-D diagnosed according to Rome III criteria and the IBS-QOL questionnaire. The experimental intervention is an infusion of donor feces via gastroscopy. The placebo intervention is an infusion of sterile saline via gastroscopy. Planned number of patients included in the study: 42 patients Planned per-protocol group: 33 patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea-predominant Irritable Bowel Syndrome
Keywords
Allogeneic microbiota reconstitution, diarrhea-predominant irritable bowel syndrome, microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum-AMR
Arm Type
Experimental
Arm Description
Patients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy
Arm Title
Placebo-AMR
Arm Type
Placebo Comparator
Arm Description
Patients receiving Placebo(Saline)-Infusion via gastroscopy
Intervention Type
Procedure
Intervention Name(s)
Allogeneic microbiota reconstitution
Intervention Description
gastroscopic microbiota Infusion (Verum)
Intervention Type
Procedure
Intervention Name(s)
Placebo-Allogeneic microbiota reconstitution
Intervention Description
gastroscopic saline Infusion (placebo)
Primary Outcome Measure Information:
Title
Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline
Time Frame
90 days after intervention
Secondary Outcome Measure Information:
Title
Improvement of IBS-QOL using IBS-QOL-questionnaire compared to baseline
Time Frame
90 days and 1 year after intervention
Title
Changes and acceptance of donor microbiome (16S rDNA-analysis)
Description
16S rDNA-analysis for microbiome biodiversity, correlation to IBS-Symptom Severity Score (IBS-SSS)
Time Frame
90 days after intervention
Title
Number of participants with treatment related adverse events
Time Frame
follow-up 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: written informed consent irritable bowel syndrome of diarrhea-predominant type according to ROME III criteria Symptoms for > 1 year before study inclusion persisting symptoms > 1 year before study inclusion relevant symptoms with reduced Quality of Life (IBS-QOL < 60 Points) no specific findings in gastroscopy and colonoscopy with biopsies in the last 2 years Exclusion Criteria: chronic inflammatory diseases gastrointestinal infectious diseases microscopic colitis celiac disease diarrhea caused by fructose- or lactose intolerance gastrointestinal malignancies or intestinal polyps irritable bowel syndrome of other type than IBS-D bile acid diarrhea constipation symptoms caused by other diseases than IBS-D dementia abdominal surgery in the last months antibiotic therapy in the last 3 months pregnancy linguistic barrier for informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas TW Seufferlein, Prof. Dr.
Organizational Affiliation
University Hospital Ulm
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Wagner, Prof. Dr.
Organizational Affiliation
University Hospital Ulm
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Frieling, Prof. Dr.
Organizational Affiliation
Helios Klinikum Krefeld
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinikum Krefeld
City
Krefeld
Country
Germany
Facility Name
Ulm University Hospital
City
Ulm
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
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Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

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