Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer

NCT ID: NCT03705442

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2020-02-09

Brief 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.

Detailed Description

The investigators plan this research to be prospective, randomized, placebo-controlled and double blinded. It will be held according to Declaration of Helsinki and in harmony with Good Clinical Practice guidelines. All patients would be required to sign informed consent, approved by the Ethics Committee of Clinical Hospital Center (CHC) Rijeka.

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). After 84 days, a regular examination will be undertaken. Total follow-up would be for two full cycles, at least 160 days. (Stool analyses will take place before and after chemotherapy(6-8 weeks after chemotherapy) and eventually three month later) Patients will be followed up in six main control points, t1, t2, t3, t4, t5, t6, which all represent the 1st day of matching 2-week-chemotherapy cycle. Each cycle starts exactly and at least 14 days from the first day of previous chemotherapy cycle. There would be no additional invasive procedures done for this study, regular blood examinations will be expanded with additional parameters. All patients would have the right to withdraw their written consent to participate in the study at any given time and for any reason whatsoever. (fecal analyses only before and 6-8 weeks after the last chemotherapy cycle)

Conditions

Colorectal Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

loperamide ("Seldiar")

Intervention Type: DRUG

All the patients will have access to standard drugs for diarrhoea

Probiotics

Omni-Biotic 10

Group Type: EXPERIMENTAL

Omni-Biotic 10

Intervention Type: DIETARY_SUPPLEMENT

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).

loperamide ("Seldiar")

Intervention Type: DRUG

All the patients will have access to standard drugs for diarrhoea

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

loperamide ("Seldiar")

All the patients will have access to standard drugs for diarrhoea

Intervention Type: DRUG

Other Intervention Names

OmniBiotic 10; Institut Allergosan; loperamide ("Seldiar"), Standard antidiarrhoeal drug

Eligibility Criteria

Inclusion Criteria

• A histologically confirmed diagnosis of colorectal cancer with metastasis;
• Patients older than 18 years of age;
• Patients starting first line of chemotherapy (FOLFIRI protocol);
• Signed patient consent form.

Exclusion Criteria

• Present ileostomy;
• Decompensated patients;
• Terminal stage patients (<6 months life expectancy);
• Patients not mentally able to adhere to the protocol;
• Patients using >3 yoghurts per week or any other probiotics;
• Or any other condition which would not allow safe administration of the drugs.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marin Golčić

OTHER

Sponsor Role: lead

Responsible Party

Marin Golčić

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marin Golcic, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Center Rijeka

Locations

Department of Radiotherapy and Oncology

Rijeka, Primorje-Gorski Kotar County, Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Marin Golcic, MD

Role: CONTACT

marin.golcic@gmail.com

51658391 ext. 385

Facility Contacts

Marin Golcic, MD

Role: primary

marin.golcic@gmail.com

51658391 ext. 385

Other Identifiers

Probat-tmcc-17

Identifier Type: -

Identifier Source: org_study_id