A Phase 2 interventional study of Omni-Biotic 10 and loperamide ("Seldiar") in Colorectal Cancer Metastatic, sponsored by Marin Golčić. Status unknown at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by Marin Golčić · Phase 2, Interventional, and Supportive care
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.
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)
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 76 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Marin Golčić as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo
Drug: loperamide ("Seldiar")
Omni-Biotic 10
Dietary Supplement: Omni-Biotic 10 · Drug: loperamide ("Seldiar")
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
All the patients will have access to standard drugs for diarrhoea
Also known as: loperamide ("Seldiar"), Standard antidiarrhoeal drug
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.
Time frame: 3 months
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
Time frame: 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)
Time frame: 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
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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