Probiotic capsule trial
| ISRCTN | ISRCTN53164826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53164826 |
| Protocol serial number | 121/6 |
| Sponsor | Estonian Science Foundation (Estonia) |
| Funder | Estonian Science Foundation ( base funding ref 0418 and 5327) |
- Submission date
- 18/04/2005
- Registration date
- 24/05/2005
- Last edited
- 23/05/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Marika Mikelsaar
Scientific
Scientific
Ravila 19
Tartu
50411
Estonia
| Phone | +372 7 374170 |
|---|---|
| marika.mikelsaar@ut.ee |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | In non-diseased host the probiotic health claims could be assessed by improvement of some measurable laboratory indices of well-established physiological functions of host, e.g. markers of antioxidative defense system. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Healthy subjects |
| Intervention | Probiotic capsule versus placebo capsule. 1. The study group members (8 males and 4 females) took three probiotic containing capsules (8.4 log colony forming unit [CFU] per capsule) two times daily (daily dose 9.2 log CFU) for three weeks. 2. The placebo group (7 males and 5 females) received identical capsules without the probiotic strain. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Probiotic |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | Inclusion criteria included the wish to participate, no known health problems, no medical conditions requiring drug therapy, no other yoghurts or no special diets. |
| Key exclusion criteria | Subjects with a history of gastrointestinal tract (GIT) disease, food allergy and acute infection, use of any antimicrobial agent within the last month or use of any regular concomitant medication were excluded. |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- Estonia
Study participating centre
Ravila 19
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/08/2005 | Yes | No |
