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The Effects of Probiotics on Intestinal Permeability in Gastrointestinal Cancer Patients in Chemotherapy

NCT03704727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-04-18

No results posted yet for this study

Summary

The aim of this study is to test the hypothesis that adjuvant administration of probiotics in cancer patients undergoing chemotherapy can reduce a chemo-induced increased intestinal permeability. Furthermore, we hypothesize that the use of probiotics may reduce the occurrence of gastrointestinal side effects such as diarrhea, abdominal pains, bacterial translocation and infections following chemotherapy.

Conditions

  • Intestinal Permeability
  • Gastrointestinal Irritation
  • Mucositis

Interventions

DIETARY_SUPPLEMENT

Probiotic

Probiotics (beneficial microorganisms) VSL#3 is a probiotic formula containing a mixture of 9x10\^10 CFU/g Lactobacilli strains (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus bulgaricus), 8x10\^10 CFU/g Bifidum strains (Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis) and 20x10\^10 CFU/g Streptococcus thermophilus

Sponsors & Collaborators

  • Actial Farmaceutica S.r.l.

    collaborator INDUSTRY

  • Nutricia, Inc.

    collaborator INDUSTRY

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Jens R Andersen, MD,MPA · University of Copenhagen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-02-01
Completion
2019-02-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

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 NCT03704727 on ClinicalTrials.gov