Faecal Bacteriotherapy for Ulcerative Colitis | NCT03104036

Studies
Faecal Bacteriotherapy for Ulcerative Colitis

NCT03104036

Sponsor

Institute for Clinical and Experimental Medicine

Status

Completed

Last Update Posted

Oct 1, 2021Actual

Enrollment

61Actual

Phase

Phase 2

Conditions

Ulcerative Colitis

Interventions

Faecal bacterial transplantation
Mesalazine 4G Enema

Countries

Czechia

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

Sep 2021

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

Jun 19, 2017Actual

Primary Completion Date

Jan 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Mar 27, 2017

First Submission Date that Met QC Criteria

Mar 31, 2017

First Posted Date

Apr 7, 2017Actual

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

Sep 29, 2021

Last Update Posted Date

Oct 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jan Březina, MUDr. (principal investigator), Institute for Clinical and Experimental MedicinePrincipal Investigator

Lead Sponsor

Institute for Clinical and Experimental MedicineOTHER_GOV

Collaborators

Name	Class
Institute of Animal Physiology and Genetics Academy of Science Czech Republic	UNKNOWN

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

The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Review of the literature on FMT suggests great potential as the treatment for UC, but two prospective controlled study that has been published yet are inconsistent.

The first objective of the project is to compare the administration of FMT enema with mesalazine enema for inducing remission in patients with active left-sided UC in the form of a prospective, randomized, controlled study. The second objective is to observe changes in the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to identify the bacterial species which are responsible for the effect of the FMT.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesalazine enema	Active Comparator	Will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week.	Drug: Mesalazine 4G Enema
Faecal bacterial transplantation enema	Experimental	Will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week.	Other: Faecal bacterial transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Faecal bacterial transplantation	Other	Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline	Faecal bacterial transplantation enema

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical remission	Mayo score ≤ 2 with no subscore > 1	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Endoscopic remission	Mayo endoscopic score = 0	Week 6 and 12
Clinical response	Decrease of Mayo score ≥ 2	Week 6 and 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Left-sided ulcerative colitis > 15cm ongoing more than 3 month
Mayo score < 10
Endoscopic Mayo score ≥ 2

Exclusion Criteria:

Anti-TNF medication in the previous 6 months
Cyclosporine in the previous 4 weeks
Methotrexate in the previous 2 months
Prednisone > 10mg
The real risk of colectomy in the near future
Positive stool culture (Salmonella, Shigella, Yersinia, Campylobacter, pathogenic E. coli)
CMV infection
Pregnancy, breastfeeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centrum péče o zažívací trakt Vítkovická nemocnice		Ostrava - Vitkovice	Moravian-Silesian Region	703 84	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019804	Mesalamine
D004733	Enema

Ancestor Terms

ID	Term
D062368	meta-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Patients will be split into two branches of the study by randomization criteria (gender, imunosupresive therapy). Each branch of the study will have 25-30 patients. The first group will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. A second group of patients will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week.