Selection of lactobacilli in biodefence
| ISRCTN | ISRCTN30946841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30946841 |
| Protocol serial number | 142/7 |
| Sponsor | Estonian Science Foundation (Estonia) |
| Funders | Estonian Science Foundation (Estonia), EU Commission (Belgium) |
- 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
Scientific
University of Tartu
Ravila 19
Tartu
50411
Estonia
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, single-arm, open trial |
| Secondary study design | Non randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lactobacilli |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
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) |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
50411
Estonia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
