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Probiotics In Colorectal Cancer Patients

NCT00936572 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2009-07-10

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

Probiotics (La1, BB536)

BIOLOGICAL

probiotics (La1, BB536)

BIOLOGICAL

placebo

Maltodoxtrin

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-06-30
Completion
2007-10-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936572 on ClinicalTrials.gov