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Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer

NCT03705442 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-10-15

No results posted yet for this study

Summary

The research will be prospective, randomised, placebo controlled and double-blinded.The research will be carried on with regards to Helsinki Declaration and following the guidelines of Good Clinical Practice.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DIETARY_SUPPLEMENT

Omni-Biotic 10

All patients will have at their disposal current medications for diarrhea based on guidelines, and education regarding side effects and dietary recommendations will be undertaken. One cohort will also ingest a probiotic (OMNi-BiOTiC® 10AAD), while other cohort will take a placebo, same in colour, shape, taste and smell; both medications will be taken 2 per day, every 12 hours, over 84 days (6 chemotherapy cycles every 14 days).

DRUG

loperamide ("Seldiar")

All the patients will have access to standard drugs for diarrhoea

Sponsors & Collaborators

  • Marin Golčić

    lead OTHER

Principal Investigators

  • Marin Golcic, MD · Clinical Hospital Center Rijeka

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2020-02-09
Completion
2020-02-09

Countries

  • Croatia

Study Locations

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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 NCT03705442 on ClinicalTrials.gov