Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer

NCT03705442 | Unknown Phase 2

• 1 other identifier: Probat-tmcc-17
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Incidence of grade III/IV diarrhoea between the two groups of patients

  To see whether application of OMNi-BiOTiC® 10 AAD probiotic will reduce grade III/IV diarrhea during the chemotherapy based on FOLFIRI protocol which would be followed by Bowel Movement Diary and Bristol Scale Stool Chart.

  3 months

Secondary Outcomes (3)

• Difference of zonulin concentration between the two groups of patients

  3 months

• Difference of vitamin D concentration between the two groups of patients

  3 months

• Difference in quality of life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) between the two groups of patients

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: loperamide ("Seldiar")

Probiotics

EXPERIMENTAL

Omni-Biotic 10

Dietary Supplement: Omni-Biotic 10; Drug: loperamide ("Seldiar")

Interventions

Omni-Biotic 10 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).

Also known as: OmniBiotic 10, Institut Allergosan

Probiotics

loperamide ("Seldiar") DRUG

All the patients will have access to standard drugs for diarrhoea

Also known as: loperamide ("Seldiar"), Standard antidiarrhoeal drug

Placebo; Probiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marin Golčić: lead

Study Sites (1)

Department of Radiotherapy and Oncology

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

RECRUITING

MeSH Terms

Interventions

Loperamide

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marin Golcic, MD

  Clinical Hospital Center Rijeka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marin Golcic, MD

CONTACT

51658391; marin.golcic@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: October 15, 2018
• Study Start: February 9, 2018
• Primary Completion: February 9, 2020
• Study Completion: February 9, 2020
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

CR (1)