Condition category
Digestive System
Date applied
22/08/2008
Date assigned
31/10/2008
Last edited
31/10/2008
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 Marika Mikelsaar

ORCID ID

Contact details

University of Tartu
Ravila 19
Tartu
50411
Estonia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

142/7

Study information

Scientific title

Rapid induction of passive immunity against weapon of bioterrorism using transformed GRAS (generally regarded as safe) bacteria

Acronym

Biodefence

Study hypothesis

To evaluate the safety of consumption of high doses of lactobacilli on selected health indices and to assess the persistence of consumed lactobacilli strains in gastrointestinal tract.

Ethics approval

Ethics Review Committee (ERC) on Human Research at the University of Tartu gave approval on the 24th October 2005 (ref: 142/7)

Study design

Interventional, single-arm, open trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Condition

Passive immunity against weapon of bioterrorism

Intervention

Fifteen participants (9 women and 6 men) were enrolled in this study. Volunteers received capsules of the freeze-dried putative probiotics (L. gasseri 177, L. acidophilus 821-3, L. gasseri E16B7, L. paracasei 317 and L. fermentum 338-1-1, 10^10 cfu each) orally for 5 days. Blood analyses were taken to exclude the infection and to test putative adverse effect of consumed lactobacilli. The persistence of lactobacilli was detected in faecal samples.

Intervention type

Drug

Phase

Not Specified

Drug names

Lactobacilli

Primary outcome measures

1. No adverse effect after consumption according to clinical, blood and intestinal indices. Timepoints of assessment: at recruitment and end of the study (day 20).
2. The best coloniser from the five tested Lactobacillus strains was detected at the end of the study (day 20)

Secondary outcome measures

Colonisation by L. acidophilus 821-3 confirmed by real time polymerase chain reaction (PCR) in faecal samples at the end of the study (day 20)

Overall trial start date

01/10/2006

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 20 - 70 years
2. Wish to participate in the study
3. Healthy (i.e. no known health problems and no medical conditions that require drug therapy)
4. Informed consent obtained

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. History of any gastrointestinal disease
2. Use of any antimicrobial drug within last month
3. Use of any regular concomitant medication, including medical preparations
4. Pregnancy/breastfeeding
5. Food allergy

Recruitment start date

01/10/2006

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Estonia

Trial participating centre

University of Tartu
Tartu
50411
Estonia

Sponsor information

Organisation

Estonian Science Foundation (Estonia)

Sponsor details

Endla 4
Tallinn
10142
Estonia

Sponsor type

Government

Website

http://www.etf.ee/index.php?setlang=eng

Funders

Funder type

Government

Funder name

Estonian Science Foundation (Estonia)

Alternative name(s)

Estonian Science Foundation, ETF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Estonia

Funder name

EU Commission (Belgium)

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