Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer

Phase 2

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: loperamide ("Seldiar"); Dietary Supplement: Omni-Biotic 10

• Registration Number: NCT03705442
• Lead Sponsor: Marin Golčić

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)

Study Timeline

• Study Start: 2018-02-09
• Study First Submitted: 2018-02-10
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Study First Posted: 2018-10-15
• Last Update Posted: 2018-10-15
• Primary Completion: 2020-02-09
• Study Completion: 2020-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	loperamide ("Seldiar")	Placebo
Probiotics	Omni-Biotic 10	Omni-Biotic 10
Probiotics	loperamide ("Seldiar")	Omni-Biotic 10

Primary Outcome Measures

Name	Time	Method
Incidence of grade III/IV diarrhoea between the two groups of patients	3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Radiotherapy and Oncology; 🇭🇷 Rijeka, Primorsko-goranska, Croatia