Effect of Fecal Microbiota Transplantation in Irritable B... | NCT02788071

Studies
Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

NCT02788071

Sponsor

Aleris-Hamlet Hospitaler København

Status

Completed

Last Update Posted

Aug 2, 2017Actual

Enrollment

52Actual

Phase

Phase 2Phase 3

Conditions

Irritable Bowel Syndrome

Interventions

FMT capsules
FMT placebo

Countries

Denmark

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

May 30, 2016

First Submission Date that Met QC Criteria

May 30, 2016

First Posted Date

Jun 2, 2016Estimated

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

Aug 1, 2017

Last Update Posted Date

Aug 2, 2017Actual

Name	Class
Hvidovre University Hospital	OTHER
University of Aarhus	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).

Detailed Description

Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity.

Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.

Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMT capsules	Experimental	FMT capsules	Dietary Supplement: FMT capsules
FMT placebo	Placebo Comparator	Placebo capsules	Dietary Supplement: FMT placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FMT capsules	Dietary Supplement	25 capsules per day for 12 days	FMT capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
symptoms score	Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in microbiota diversity	Measured by DNA sequencing	Day 4, 4 weeks, 12 weeks and 24 weeks
Microbiota diversity IBS patients	Measured by DNA sequencing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fulfilled Rome III diagnostic criteria for IBS
Moderate-severe disease activity (IBS-Symptom Severity Score ≥175)
Able to read and speak Danish
Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool

Exclusion Criteria:

Other chronic gastrointestinal disease
Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile
Positive screening for HIV, Hepatitis B or HCV antibody
Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures)
Psychiatric disorder
Fecal calprotectin ≥ 50 mg/kg
Abuse of alcohol or drugs
Medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines
Abnormal screening biochemistry
Abnormal colonoscopy findings
Pregnant, planned pregnancy or breastfeeding females
Ingestion of probiotics or antibiotics < 8 weeks before the inclusion

Inclusion criteria for donors

Age between 18-45 years
Past and current healthy
Normal weight (BMI between 18,5-24,9 kg/m2)
Normal bowel movements (defined as 1-2 per day and type 3-4 at Bristol Stool Form Scale)
No medication consumption

Exclusion criteria for donors

Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
Positive stool sample for C. difficile toxin, parasites or other pathogens
Antibiotic treatment in the past 6 months
Abuse of alcohol or drugs
Smoking
Tattoo or body piercing within the last 6 months
Allergy, asthma or eczema
Family history of gastrointestinal diseases
Participation in high-risk sexual behaviors
Born by Caesarean section

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alice Højer Christensen, MD, PhD	Aleris-Hamlet Hospitaler København	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Aleris Hamlet Hospitaler, København		Copenhagen	Søborg	2760	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29980607	Derived	Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.

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

ID	Term
D001691	Biological Therapy
D013812	Therapeutics