Condition category
Digestive System
Date applied
28/06/2005
Date assigned
12/09/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Louis MA Akkermans

ORCID ID

Contact details

Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 30 2508074
l.m.a.akkermans@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04-088

Study information

Scientific title

Acronym

Study hypothesis

Ecologic 641 (a multispecies probiotic) is well tolerated and is capable of modifying gut flora.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Healthy volunteers and ileostomy patients after ulcerative colitis

Intervention

Administration of probiotics or placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Ecologic 641 (a multispecies probiotic)

Primary outcome measures

Tolerance of study product and gut flora modification

Secondary outcome measures

Side effects, discomfort scores (visual analogue scale [VAS] scale)

Overall trial start date

01/08/2004

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

10 healthy volunteers and 10 ileostomy patients after ulcerative colitis

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Use of antibiotics and/or probiotics within 2 weeks prior to randomisation

Recruitment start date

01/08/2004

Recruitment end date

01/07/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

Individual Sponsor (Netherlands)

Sponsor details

Prof Louis MA Akkermans
Heidelberglaan 100
Utrecht
3584CX
Netherlands
+31 30 2508074
l.m.a.akkermans@umcutrecht.nl

Sponsor type

Not defined

Website

http://www.prosearch.nl

Funders

Funder type

Government

Funder name

Senter, an agency of the Dutch Ministry of Economic Affairs, funded this study (grant number: TSGE3109) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes