A Phase 3 interventional study of Probiotic formula and Placebo in Colorectal Cancer, sponsored by Monsea Ltd.. Completed at 6 sites in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-23.
Sponsored by Monsea Ltd. · Phase 3, Interventional, and Treatment
Irinotecan is one of key drug used in the treatment of colorectal cancer. The incidence of irinotecan induced diarrhea varies between 60-90%, with severe diarrhea in 20-40%. The main cause of diarrhea is one of irinotecan metabolites, SN-38 which is in the liver glucuronidated and subsequently expelled into the intestine. Due to the bacterial enzyme beta-D-glucuronidase in intestinal lumen it is deconjugated. This form causes direct damage of intestinal mucosa associated with malabsorption and the development of diarrhea. It is known that probiotic bacteria, reduce activity of intestinal beta-D-glucuronidase and therefore these bacteria could be applied in the prevention of diarrhea in patients treated by this food supplement. Given their low toxicity, good tolerability, probiotics may be an important part of supportive therapy. This is a first study aimed to determine the effectiveness of the probiotics in the prophylaxis of irinotecan induced diarrhea due to reduction intestinal beta-D-glucuronidase activity.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's enrollment of 46 is below the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →This is the only study on the registry with Monsea Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receiving probiotics.
Dietary Supplement: Probiotic formula
Patients receiving placebo
Dietary Supplement: Placebo
Probiotic formula Colon DophilusTM , will be administered at a dose of 3x1 cps per day orally for 12 weeks. In the first cycle the starting dose is 3x1 cps per day. In other cycles the starting dose is 3x1 cps per day, or the dose according to dose adjustments from the previous treatment cycle.
Placebo capsules will be administered at a dose of 3x1 cps per day orally for 12 weeks. In the first cycle the starting dose is 3x1 cps per day. In other cycles the starting dose is 3x1 cps per day, or the dose according to dose adjustments from the previous treatment cycle.
Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy
Time frame: 2 years
Prevention of any grade of diarrhea
Time frame: 2 years
Number of patients with any grade 3 or 4 toxicity or SAE related toxicity.
Number of patients with any grade 3 or 4 toxicity or SAE related toxicity according to NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
Time frame: 2 years
Number of patients with any grade gastrointestinal symptoms
Number of patients with any grade gastrointestinal symptoms (enteritis, colitis, constipation, abdominal distension, bloating, flatulence, gastritis, dyspepsia,nausea, vomiting) according to NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE.
Time frame: 2 years
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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