Stem Cell Transplant ComplicationsPhase 3NCT06791746

Compound Staphylococcal Lysostaphin Vs. Chlorhexidine Mouthrinse for Oral Mucositis in Patients Undergoing Allo-HSCT

A Phase 3 study testing compound Staphylococcal lysostaphin mouthrinse and chlorhexidine mouthrinse in people with Stem Cell Transplant Complications and Oral Mucositis, run by Zhejiang University at 1 site in China.

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

Who is it for?: Any age
Conditions the study is for: Stem Cell Transplant Complications, Oral Mucositis
What is being tested?: compound Staphylococcal lysostaphin mouthrinse and chlorhexidine mouthrinse
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 388 participants
Where: 1 siteChina
Study dates: 2 Jan 2020to 30 Jun 2022
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients with malignant hematological diseases who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT) from fully matched sibling donors, unrelated donors, or haploidentical related donors.
The conditioning regimen is myeloablative, specifically the BUCY regimen (comprising cytarabine, busulfan, and cyclophosphamide), with methotrexate used for graft-versus-host disease (GVHD) prophylaxis. The dosage of cytarabine is ≥4.0g/m²/day, busulfan is ≥3.2mg/m²/day, and cyclophosphamide is ≥1.8g/m²/day.
There are no restrictions on age or gender.
Patients voluntarily agree to participate in this trial.

Who cannot join

Patients with an expected survival time of less than one month;
Patients who have already developed oral mucositis (OM) prior to conditioning;
Patients undergoing autologous stem cell transplantation;
Patients receiving a non-myeloablative conditioning regimen.

Trial locations and contacts

1 site in 1 country.

China1 site

Bone marrow transplantation center, the First Affiliated Hospital of Medical College, Zhejiang University, Hangzhou, China
Hangzhou, Zhejiang

Other trials in China

About this study

Official title: Compound Staphylococcal Lysostaphin Versus Chlorhexidine Mouthrinse for the Prophylaxis of Oral Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: a Randomized, Controlled, Non-inferiority Clinical Tria

Oral mucositis (OM) is a common complication in patients receiving myeloablative conditioning allogeneic hematopoietic stem cell transplantation (allo-HSCT). Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM, yet its use is hampered by issues like tooth discoloration, unpleasant taste, and pain on ulcerated surfaces, leading to reduced patient compliance. This study aims to demonstrate the non-inferior efficacy of a compound Staphylococcal lysostaphin mouthrinse to that of chlorhexidine mouthrinse in reducing OM occurrence in patients receiving myeloablative conditioning allo-HSCT.

Read the detailed description

This study aims to demonstrate the non-inferior efficacy of a compound Staphylococcal lysostaphin mouthrinse (Xinjingjie Mouthrinse®) to that of chlorhexidine mouthrinse in reducing OM occurrence in patients receiving myeloablative conditioning allo-HSCT. It also seeks to observe patient treatment adherence and pain, so as to provide evidence for the appropriate OM prevention and management measures in clinical practice. This randomized, controlled, non-inferiority clinical trial was conducted at the Bone Marrow Transplant Center, the First Affiliated Hospital of Medical College, Zhejiang University from January 2020 to December 2021.

Conditions: Stem Cell Transplant Complications, Oral Mucositis
Being tested: compound Staphylococcal lysostaphin mouthrinse, chlorhexidine mouthrinse
Medical subject headings: Stomatitis

What participants receive

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

compound Staphylococcal lysostaphin mouthrinseDrug
Lysostaphin is a proteolytic enzyme produced by a specific species of Staphylococcus, uniquely capable of cleaving the cross-linking pentaglycine bridges within the cell walls of Staphylococcus aureus.
chlorhexidine mouthrinseDrug
Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM.

Study groups in NCT06791746
Study group	Role	What they receive
compound Staphylococcal lysostaphin mouthrinse	Experimental	Patients in the compound Staphylococcal lysostaphin mouthrinse group received OM prophylaxis by sequential gargling with 15 ml of sodium bicarbonate mouthrinse and 15 ml of compound Staphylococcal lysostaphin mouthrinse. Receives: Drug: compound Staphylococcal lysostaphin mouthrinse
chlorhexidine mouthrinse	Active comparator	The chlorhexidine mouthrinse group followed the same protocol using 15 ml of sodium bicarbonate mouthrinse and 15 ml of chlorhexidine mouthrinse. Receives: Drug: chlorhexidine mouthrinse

What is being measured

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

cumulative incidence of oral mucositis
Measured: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).

Secondary outcomes (6)

severity of oral mucositis
The severity of OM was assessed according to the WHO grading criteria.
Measured: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
the onset time of oral mucositis
Measured: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
oral pain
Oral pain was evaluated using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher numbers indicating greater pain intensity.
Measured: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
compliance with mouth rinsing
Compliance was measured by the average daily frequency of mouthrinse use.
Measured: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
the number of days new analgesics are used due to OM
Measured: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
time to neutrophil engraftment
Neutrophil engraftment was defined as three consecutive days with a neutrophil count >0.5×10e9/L.
Measured: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).

Timeline

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

2 Jan 202030 Jun 2022

First posted24 Jan 2025
Study start2 Jan 2020
Primary completion31 Dec 2021
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
More trials run by Zhejiang UniversityThe sponsor's other registered studies.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 388 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06791746
Sponsor's protocol ID: 2019.1114
Status last verified: Jan 2025
First submitted: 13 Jan 2025
Last updated: 24 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stem Cell Transplant Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Compound Staphylococcal Lysostaphin Versus Chlorhexidine Mouthrinse for the Prophylaxis of Oral Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: a Randomized, Controlled, Non-inferiority Clinical Tria
ClinicalTrials.gov ID: NCT06791746
Acronym / sponsor ID: 2019.1114
Conditions: Stem Cell Transplant Complications, Oral Mucositis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 388 participants (actual)
Lead sponsor: Zhejiang UniversityUniversity, hospital or other
Study start: 2 Jan 2020 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 24 Jan 2025 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
compound Staphylococcal lysostaphin mouthrinse	Experimental	Drug: compound Staphylococcal lysostaphin mouthrinsePatients in the compound Staphylococcal lysostaphin mouthrinse group received OM prophylaxis by sequential gargling with 15 ml of sodium bicarbonate mouthrinse and 15 ml of compound Staphylococcal lysostaphin mouthrinse.
chlorhexidine mouthrinse	Active comparator	Drug: chlorhexidine mouthrinseThe chlorhexidine mouthrinse group followed the same protocol using 15 ml of sodium bicarbonate mouthrinse and 15 ml of chlorhexidine mouthrinse.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Patients with malignant hematological diseases who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT) from fully matched sibling donors, unrelated donors, or haploidentical related donors.
The conditioning regimen is myeloablative, specifically the BUCY regimen (comprising cytarabine, busulfan, and cyclophosphamide), with methotrexate used for graft-versus-host disease (GVHD) prophylaxis. The dosage of cytarabine is ≥4.0g/m²/day, busulfan is ≥3.2mg/m²/day, and cyclophosphamide is ≥1.8g/m²/day.
There are no restrictions on age or gender.
Patients voluntarily agree to participate in this trial.

Key exclusion criteria (4 listed)

Patients with an expected survival time of less than one month;
Patients who have already developed oral mucositis (OM) prior to conditioning;
Patients undergoing autologous stem cell transplantation;
Patients receiving a non-myeloablative conditioning regimen.

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
compound Staphylococcal lysostaphin mouthrinseLysostaphin is a proteolytic enzyme produced by a specific species of Staphylococcus, uniquely capable of cleaving the cross-linking pentaglycine bridges within the cell walls of Staphylococcus aureus.	Drug	compound Staphylococcal lysostaphin mouthrinse
chlorhexidine mouthrinseChlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM.	Drug	chlorhexidine mouthrinse

Primary outcome

cumulative incidence of oral mucositis
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).

6 secondary outcomes

severity of oral mucositis
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
the onset time of oral mucositis
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
oral pain
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
compliance with mouth rinsing
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
the number of days new analgesics are used due to OM
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
time to neutrophil engraftment
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Stem Cell Transplant Complications

Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Active, not recruitingObservational study
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Bone Marrow Transplant Complications
Not yet recruitingPhase 1
Expanded Donor Stem Cells for Poor Graft Function After Stem Cell Transplantation in Children
Poor Graft Function, Hematopoietic Stem Cell Transplantation Complications
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 24 Jan 2025. 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 China. 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 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?

cumulative incidence of oral mucositis (time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).). 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 NCT06791746.

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 24 Jan 2025.