Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer (Probat-tmcc-17)

Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer: Randomized Double-blind Placebo-controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Drug: loperamide ("Seldiar"); Dietary supplement: Omni-Biotic 10

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)

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• Croatia
  • Primorsko-goranska
    • Rijeka, Primorsko-goranska, Croatia, 51000
      • Recruiting
      • Department of Radiotherapy and Oncology
      • Contact: Marin Golcic, MD; Phone Number: 385 51658391; Email: marin.golcic@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: loperamide ("Seldiar"); All the patients will have access to standard drugs for diarrhoea; Other Names: loperamide ("Seldiar"), Standard antidiarrhoeal drug
Experimental: Probiotics; Omni-Biotic 10	Drug: loperamide ("Seldiar"); All the patients will have access to standard drugs for diarrhoea; Other Names: loperamide ("Seldiar"), Standard antidiarrhoeal drug; 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).; Other Names: OmniBiotic 10; Institut Allergosan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of zonulin concentration between the two groups of patients	To see whether the group on probiotics will have lower values of calprotectin and zonulin14	3 months
Difference of vitamin D concentration between the two groups of patients	To see whether the group on probiotics will have higher values of vitamin D (blood)	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	To see whether the group on probiotics will have higher scores in EORCT QLQ-C30	3 months

Collaborators and Investigators

• Sponsor: Marin Golčić
• Investigators: Principal Investigator: Marin Golcic, MD, Clinical Hospital Center Rijeka

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Anticipated): February 9, 2020
• Study Completion (Anticipated): February 9, 2020

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Gastrointestinal Agents; Loperamide; Antidiarrheals
• Other Study ID Numbers: Probat-tmcc-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No