MucositisPhase 2/3NCT02085694
Lactobacillus Brevis CD2 Preventing Oral Mucositis
A Phase 2/3 study testing Lactobacillus brevis CD2 in people with Mucositis, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mucositis
- What is being tested?
- Lactobacillus brevis CD2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Karnofsky Performance Score ≥ 70%.
- Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy
- Patients eligible to receive high-dose chemotherapy as part of conditioning regimen
- Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)
- Serum creatinine < 1.8mg/dl
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- Total bilirubin < 2mg/dl
- Liver enzymes within three times of normal limit
- Expected survival > 6 months.
Who cannot join
- Pregnant women and lactating mothers
- Patients with history of HIV infection
- Patients who have taken any other investigational product in last 4 weeks
- Patients having untreated symptomatic dental infection
- Patients with WHO Grade 3 or 4 oral Mucositis
- Other serious concurrent illness
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- Inconclusive hematological diagnosis
- Patients with signs and symptoms of systemic infections
- Patient's/guardian's refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Universitario "A. GEMELLI"
Rome, Rome, 00168
Patrizia Chiusolo, MD, 0039-0630155300, p.chiusolo@rm.unicatt.it
Sabrina Giammarco, MD, 0039-0630155300, sabrina_giammarco@libero.it
About this study
Official title: A Pilot Study on the Efficacy of Lactobacillus Brevis CD2 Lozenges in Preventing Oral Mucositis by High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation
A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT.
Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.
- Conditions
- Mucositis
- Being tested
- Lactobacillus brevis CD2
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus brevis CD2Drug
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus brevis CD2 lozenges | Experimental | Not described Receives: Drug: Lactobacillus brevis CD2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
Measured: days -14;-7; 0;+7;+14;+21
Secondary outcomes (1)
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM
Measured: days -14;-7; 0; +7;+14; +21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sabrina giammarco, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085694
- Sponsor's protocol ID
- 001/14
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2014
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Efficacy of Lactobacillus Brevis CD2 Lozenges in Preventing Oral Mucositis by High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02085694
- Acronym / sponsor ID
- 001/14
- Conditions
- Mucositis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- 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.
A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT.
Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus brevis CD2 lozenges | Experimental | Drug: Lactobacillus brevis CD2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 65 years
- Karnofsky Performance Score ≥ 70%.
- Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy
- Patients eligible to receive high-dose chemotherapy as part of conditioning regimen
- Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)
Key exclusion criteria (9 listed)
- Pregnant women and lactating mothers
- Patients with history of HIV infection
- Patients who have taken any other investigational product in last 4 weeks
- Patients having untreated symptomatic dental infection
- Patients with WHO Grade 3 or 4 oral Mucositis
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 |
|---|---|---|
| Lactobacillus brevis CD2 | Drug | Lactobacillus brevis CD2 lozenges |
Primary outcome
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
Time frame: days -14;-7; 0;+7;+14;+21
1 secondary outcome
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM
Time frame: days -14;-7; 0; +7;+14; +21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lactobacillus brevis CD2 in people with Mucositis, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 9 inclusion and 9 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 13 Mar 2014. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis (time frame: days -14;-7; 0;+7;+14;+21). 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 13 Mar 2014.