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Colorectal CancerPhase 3NCT01410955

Prevention of Irinotecan Induced Diarrhea by Probiotics

A Phase 3 study testing Probiotic formula in people with Colorectal Cancer, run by Monsea Ltd. at 6 sites in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Probiotic formula
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
6 sitesSlovakia
Study dates
Dec 2011to Jan 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • signed written informed consent
  • histologically proven colorectal cancer patients started new line of chemotherapy based on irinotecan
  • ECOG PS 0 - 1 at study entry
  • life expectancy more than 3 months
  • absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;

Who cannot join

  • impossibility to take oral medication
  • active infection treated by antibiotic therapy
  • ileostomy
  • hypersensitivity to study drug
  • any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years.
  • serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator )

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Slovakia6 sites

  • St.James Hospital and Clinic

    Bardejov, 085 01

  • Oncologic Institute of St.Elisabeth OUSA

    Bratislava, 81250

  • National Cancer Institute, Slovakia

    Bratislava, 833 10

  • Zdravspol s r.o. - oncologic ambulance

    Komárno, 94501

  • POKO Poprad Ltd.

    Poprad, 058 01

  • Faculty Hospital Trencin

    Trenčín, 91101

Other trials in Slovakia

About this study

Official title: Prevention of Irinotecan Induced Diarrhea by Probiotics. A Phase III Study

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.

Being tested
Probiotic formula, Placebo
Keywords
probiotics, diarrhoea, prevention, colon cancer, irinotecan
Medical subject headings
Colorectal Neoplasms, Diarrhea, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic formulaDietary supplement

    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.

  • PlaceboDietary supplement

    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.

Study groups in NCT01410955
Study groupRoleWhat they receive
ProbioticsExperimentalPatients receiving probiotics.
Receives: Dietary Supplement: Probiotic formula
PlaceboPlacebo comparatorPatients receiving placebo
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy

    Measured: 2 years

Secondary outcomes (3)

  1. Prevention of any grade of diarrhea

    Measured: 2 years

  2. 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).

    Measured: 2 years

  3. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01410955
Sponsor's protocol ID
900450001
Status last verified
Jan 2014
First submitted
26 Apr 2011
Last updated
23 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Probiotic formula in people with Colorectal Cancer, run by Monsea Ltd. at 6 sites in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01410955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014; AzTrials last refreshed its copy on 7 Nov 2026.

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