Efficacy of probiotics and selective decontamination of the digestive tract in reducing bacterial translocation in patients with pylorus preserving pancreaticoduodenectomy
| ISRCTN | ISRCTN71637623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71637623 |
| Secondary identifying numbers | NTR280 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 28/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Dr M A Boermeester
Scientific
Scientific
Academic Medical Centre
Departement of Surgery
G4-109.2
P.O. Box 226600
Amsterdam
1100 DD
Netherlands
| m.a.boermeester@amc.uva.nl |
Study information
| Study design | Multicentre randomised single-blind active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SDD-PRO-Whipple Study |
| Study objectives | Peri-operative administration of probiotics or selective decontamination of the digestive tract (SDD) has an effect on small bowel bacterial overgrowth and bacterial translocation to lymph nodes in patients undergoing pylorus preserving pancreaticoduodenectomy (PPPD) by protecting or enhancing bowel (mucosa) permeability. |
| Ethics approval(s) | Received from the local ethics committee |
| Health condition(s) or problem(s) studied | Bacterial translocation in pancreaticoduodenectomy |
| Intervention | After informed consent, patients will be randomly assigned to three groups: Group A (n = 10): probiotics Group B (n = 10): selective decontamination of the digestive tract (SDD) Group C (n = 10): standard treatment All patients will receive standardised anaesthesia and post-operative analgesia. The effect of pre-operative prophylaxis regimes can be assessed by bacterial counts in a small jejunal biopsy and an adjacent lymph nodes. Also the effect of the prophylactic regimes on gut permeability, cytokine production and faecal flora will be assessed. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Intestinal permeability and bacterial translocation following major pancreaticobiliary surgery. |
| Secondary outcome measures | 1. Effect of probiotics compared to control treatment on intestinal permeability after major pancreaticobiliary surgery 2. Effect of probiotics compared to control treatment on bacterial translocation to bowel wall and mesenteric lymph nodes 3. Comparison of probiotics to SDD on parameters of intestinal permeability and bacterial translocation 4. Determination of intestinal bacterial overgrowth after probiotics or SDD peri-operative treatment versus control treatment 5. Determination of systemic and local inflammatory response due to bacterial translocation after probiotics or SDD |
| Overall study start date | 01/04/2005 |
| Completion date | 01/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Aged greater than 18 years, either sex 2. Patients planned for pylorus preserving pancreaticoduodenectomy for suspected malignant or premalignant disease 3. Informed consent |
| Key exclusion criteria | 1. Antibiotics within a week prior to surgery (peri-operative antibiotics are allowed) 2. Use of other probiotic products 4 weeks before or during the study 3. Non-resectable cancer of the pancreas |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Winclove BioIndustries BV (Netherlands)
Industry
Industry
Papaverweg 36-B
P.O. Box 37239
Amsterdam
1030 AE
Netherlands
| Website | http://www.winclove.nl/ |
|---|---|
"ROR" |
https://ror.org/02c0pn910 |
Funders
Funder type
Not defined
Not provided at time of registration
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 |
