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
Protocol serial number	NTR280
Sponsor	Winclove BioIndustries BV (Netherlands)
Funder	Not provided at time of registration

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

Academic Medical Centre
Departement of Surgery
G4-109.2
P.O. Box 226600
Amsterdam
1100 DD
Netherlands

Email	m.a.boermeester@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised single-blind active controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	Intestinal permeability and bacterial translocation following major pancreaticobiliary surgery.
Key secondary outcome measure(s)	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
Completion date	01/02/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan