Lactobacillus Acidophilus and Bifidobacterium Animalis Su... | NCT00268164

Studies
Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

NCT00268164

Sponsor

Hvidovre University Hospital

Status

Terminated

Last Update Posted

May 6, 2015Estimated

Enrollment

Phase

Phase 2

Conditions

Ulcerative Colitis

Interventions

lactobacilus acidophilus & bifidobacterium animalis/lactis

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

Sep 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inclusion was difficult and to slow

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Dec 21, 2005

First Submission Date that Met QC Criteria

Dec 21, 2005

First Posted Date

Dec 22, 2005Estimated

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 5, 2015

Last Update Posted Date

May 6, 2015Estimated

Name	Class
Novonesis	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine whether the lactic acid bacteria " Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12)" is effective as maintenance treatment in ulcerative colitis.

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

Name	Type	Description	Arm Group Labels	Other Names
lactobacilus acidophilus & bifidobacterium animalis/lactis	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with relapse at 12 month.

Secondary Outcomes

Measure	Description	Time Frame
Number of days to relapse.
Presence and concentrations of the probiotic bacterial strains in stool.
Safety and tolerance of the probiotic mixture.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year.

Exclusion Criteria:

Pregnancy and lactating
Serious underlying disease other than UC
Former gastrointestinal resections
Medication for UC other than mesalazine
Known allergic reactions towards compounds in the study drug.
Expected lack of compliance due to mental state or language problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Flemming Bendtsen, MD, DMSci	Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Medical Gastroenterology		Hvidovre	Hvidovre	2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21453880	Derived	Wildt S, Nordgaard I, Hansen U, Brockmann E, Rumessen JJ. A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis. J Crohns Colitis. 2011 Apr;5(2):115-21. doi: 10.1016/j.crohns.2010.11.004. Epub 2011 Jan 8.

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