The effect of oral administration of a multispecies probiotic product in healthy volunteers and ileostomy patients; double-blind, placebo-controlled, cross-over trial
| ISRCTN | ISRCTN45167712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45167712 |
| Secondary identifying numbers | 04-088 |
- Submission date
- 28/06/2005
- Registration date
- 12/09/2005
- Last edited
- 14/09/2009
- 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 Louis MA Akkermans
Scientific
Scientific
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Phone | +31 30 2508074 |
|---|---|
| l.m.a.akkermans@umcutrecht.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Ecologic 641 (a multispecies probiotic) is well tolerated and is capable of modifying gut flora. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Healthy volunteers and ileostomy patients after ulcerative colitis |
| Intervention | Administration of probiotics or placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ecologic 641 (a multispecies probiotic) |
| Primary outcome measure | Tolerance of study product and gut flora modification |
| Secondary outcome measures | Side effects, discomfort scores (visual analogue scale [VAS] scale) |
| Overall study start date | 01/08/2004 |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 10 healthy volunteers and 10 ileostomy patients after ulcerative colitis |
| Key exclusion criteria | Use of antibiotics and/or probiotics within 2 weeks prior to randomisation |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 01/07/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
Individual Sponsor (Netherlands)
Not defined
Not defined
Prof Louis MA Akkermans
Heidelberglaan 100
Utrecht
3584CX
Netherlands
| Phone | +31 30 2508074 |
|---|---|
| l.m.a.akkermans@umcutrecht.nl | |
| Website | http://www.prosearch.nl |
Funders
Funder type
Government
Senter, an agency of the Dutch Ministry of Economic Affairs, funded this study (grant number: TSGE3109) (Netherlands)
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 |
