Selection of lactobacilli in biodefence

ISRCTN	ISRCTN30946841
DOI	https://doi.org/10.1186/ISRCTN30946841
Secondary identifying numbers	142/7

Submission date: 22/08/2008
Registration date: 31/10/2008
Last edited: 31/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marika Mikelsaar
Scientific

University of Tartu
Ravila 19
Tartu
50411
Estonia

Study information

Study design	Interventional, single-arm, open trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Other
Study type	Diagnostic
Scientific title	Rapid induction of passive immunity against weapon of bioterrorism using transformed GRAS (generally regarded as safe) bacteria
Study acronym	Biodefence
Study objectives	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(s)	Ethics Review Committee (ERC) on Human Research at the University of Tartu gave approval on the 24th October 2005 (ref: 142/7)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lactobacilli
Primary outcome measure	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 study start date	01/10/2006
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	15
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	01/09/2007

Locations

Countries of recruitment

Estonia

Study participating centre

University of Tartu

Tartu
50411
Estonia

Sponsor information

Estonian Science Foundation (Estonia)
Government

Endla 4
Tallinn
10142
Estonia

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

Funders

Funder type

Government

Estonian Science Foundation (Estonia)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Estonian Science Foundation, ETF
Location: Estonia

EU Commission (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan