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
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