Colorectal Cancer MetastaticPhase 2Probat-tmcc-17NCT03705442
Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing Omni-Biotic 10 and loperamide ("Seldiar") in people with Colorectal Cancer Metastatic, run by Marin Golčić at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Omni-Biotic 10 and loperamide ("Seldiar")
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteCroatia
- Study dates
- 9 Feb 2018to 9 Feb 2020
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Department of Radiotherapy and Oncology
Rijeka, Primorje-Gorski Kotar County, 51000
Marin Golcic, MD, 51658391 ext. 385, marin.golcic@gmail.com
About this study
Official title: 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.
Read the 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)
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Omni-Biotic 10, loperamide ("Seldiar")
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omni-Biotic 10Dietary supplement
Also called OmniBiotic 10, Institut Allergosan
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).
loperamide ("Seldiar")Drug
Also called loperamide ("Seldiar"), Standard antidiarrhoeal drug
All the patients will have access to standard drugs for diarrhoea
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: loperamide ("Seldiar") |
| Probiotics | Experimental | Omni-Biotic 10 Receives: Dietary Supplement: Omni-Biotic 10; Drug: loperamide ("Seldiar") |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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
Measured: 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)
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start9 Feb 2018
- Primary completion9 Feb 2020 (estimated)
- Study completion9 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marin Golčić
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marin Golčić, University Hospital Rijeka
- Investigators
- Marin Golcic, MD, Principal investigator, Clinical Hospital Center Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705442
- Sponsor's protocol ID
- Probat-tmcc-17
- Acronym
- Probat-tmcc-17
- Status last verified
- Oct 2018
- First submitted
- 10 Feb 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer: Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03705442
- Acronym / sponsor ID
- Probat-tmcc-17 / Probat-tmcc-17
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Marin GolčićUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 9 Feb 2020 (estimated)
- Study completion
- 9 Feb 2020 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: loperamide ("Seldiar")Placebo |
| Probiotics | Experimental | Dietary Supplement: Omni-Biotic 10, Drug: loperamide ("Seldiar")Omni-Biotic 10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omni-Biotic 10Also: OmniBiotic 10, Institut AllergosanAll 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). | Dietary supplement | Probiotics |
| loperamide ("Seldiar")Also: loperamide ("Seldiar"), Standard antidiarrhoeal drugAll the patients will have access to standard drugs for diarrhoea | Drug | Placebo, Probiotics |
Primary outcome
Incidence of grade III/IV diarrhoea between the two groups of patients
Time frame: 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.
3 secondary outcomes
Difference of zonulin concentration between the two groups of patients
Time frame: 3 months
Difference of vitamin D concentration between the two groups of patients
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
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marin Golcic, MD principal investigator
Clinical Hospital Center Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omni-Biotic 10 and loperamide ("Seldiar") in people with Colorectal Cancer Metastatic, run by Marin Golčić at 1 site in Croatia.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marin Golcic, MD (51658391 ext. 385, marin.golcic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade III/IV diarrhoea between the two groups of patients (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2018.