NCT00936572

Brief Summary

Design: double blind controlled randomized trial with a parallel design and 3 treatment groups Description of subjects: Patients admitted in study centers for colorectal surgery under laporoscopy and/or laparotomy. Product: Product 1: BB536 and LA1 (10E9) Product 2: BB536 and LA1 (10E7) Placebo: Maltodextrin Number of patients: enrolled subjects: n=33, ITT data set: n=31, PP data set: n=30 Primary objective: Colonization (biopsy+stools) of each bacteria for one of the dose at D0 (surgical procedure) Secondary objectives:

  • Influence of the probiotic bacteria on the gut microflora
  • Modulation of the immune and inflammatory response Additional objectives:
  • Investigate dose effect on La1 colonization
  • Investigate the effect of La1 colonization, treatment without La1 colonization, and absence of treatment and La1 colonization on other bacteria and on immunological parameters

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

8 months

First QC Date

July 7, 2009

Last Update Submit

July 9, 2009

Conditions

Colorectal Cancer

Keywords

ProbioticsLa1BB536Colorectal surgeryIntestinal immunityDendritic cellsLymphocyteMicrobiota

Outcome Measures

Primary Outcomes (1)

  • Primary Efficacy Parameters: morphological and microbiological evaluation of the colonic microflora, gastrointestinal function

Secondary Outcomes (1)

  • Secondary Efficacy Parameters: immune and inflammatory response, bacterial translocation

Study Arms (3)

high dose

EXPERIMENTAL

high dose of probiotics (109 cfu)

Procedure: Probiotics (La1, BB536)

low dose

EXPERIMENTAL

low dose of probiotics (107 cfu)

Biological: probiotics (La1, BB536)

probiotics

PLACEBO COMPARATOR

Maltodoxtrin

Biological: placebo

Interventions

probiotics (La1, BB536)PROCEDURE
high dose
placeboBIOLOGICAL

Maltodoxtrin

probiotics

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between 18 and 80 years of age
  • Documented cancer disease of the colorectum as diagnos pre-operatively by positive histology.
  • Documented bowel disease (IBD, diverticular disease etc) as diagnosed by barium X-Ray or endoscopy.
  • Elective colorectal surgery
  • Surgical hospital length of stay anticipated to be at least 8 days
  • Stool sample available at Day-3 pre-operatively
  • Receiving full enteral / oral nutrition
  • Written informed consent (by subject or legal guardian)

You may not qualify if:

  • Perioperative unresectable tumours
  • Perioperative neoplastic ascitis
  • Emergency colorectal surgery
  • Clinically relevant pulmonary or cardiovascular failure
  • Liver failure (known cirrhosis or total bilirubin \>3 mg/dl)
  • Kidney failure (receiving renal dialysis or serum creatinine \>2 mg/dl)
  • Patients receiving total parenteral nutrition (TPN)
  • Immunological disorders
  • Ongoing or recent infections (within last 10 days)
  • Pregnant (patient's declaration)
  • Participation in another clinical trial
  • SUBJECT SELECTION CRITERIA
  • Population Base: Patients with diagnosis of disease of the colorectum, elective for colorectal surgery
  • Both sexes with age greater than 18 years.
  • Documented disease of the colorectum, candidate to major elective surgery.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gianotti Luca Vittorio

Monza, 20052, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 10, 2009

Study Start

October 1, 2006

Primary Completion

June 1, 2007

Study Completion

October 1, 2007

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

IT(1)