Pediatric CancerMaCROSNCT03785938
Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer
A study testing Probiotic in people with Pediatric Cancer, run by University of Leeds.
Trial summary
The aim of this study is to evaluate the feasibility of an randomised-controlled trial to investigate the efficacy of liquid probiotics to prevent or reduce mucositis and infection in children diagnosed with cancer who are undergoing treatment with regimes likely to cause mucositis. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2019to 20 Aug 2019
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the ages of 1 and 18 treated on paediatric cancer protocols receiving chemotherapy on regimens likely to cause mucositis.
Who cannot join
- Patients who have already started the course of chemotherapy. Patients receiving radiotherapy or surgery alone. Patients diagnosed with an immunodeficiency (excluding IgA). Patients who have previously taken probiotics within the month prior to commencing the course of chemotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer: a Randomised-controlled Feasibility Study
The aim of this study is to evaluate the feasibility of an randomised-controlled trial to investigate the efficacy of liquid probiotics to prevent or reduce mucositis and infection in children diagnosed with cancer who are undergoing treatment with regimes likely to cause mucositis.
Read the detailed description
TRIAL DESIGN
This will be a single-centre double-blind randomised-controlled feasibility study.
TRIAL SETTING
This study will take place at Leeds Teaching Hospital Trust (LTHT), Leeds UK. Participants will be approached whilst admitted as inpatients (typically the paediatric haematology oncology wards) and during outpatient clinics.
METHOD
Allocation sequence from a randomisation schedule will be generated A screening or trial ID number will be assigned to each participant.
The allocation sequence will be concealed from health care professionals, participants and families. Only the pharmacy team involved in randomisation, allocation will not be blinded to allocation sequence and generation.
Following identification, confirmation of eligibility, consent and allocation of trial ID of the participant, a prescription will be produced and the probiotic or placebo will be allocated accordingly.
Appearance of the intervention and placebo will be similar in appearance, smell and taste. The placebo will include maltdextrin (a polysaccharide). Both the probiotic and placebo will be produced by the company Symprove.
Participants will start the course of probiotic or placebo on the first day of their course of chemotherapy orally, or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows:
1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day Placebo will be delivered in similar, packaging, appearance and taste.
Participants or their parents will be asked to fill in a diary (paper or electronic using a web-app) daily for 21 days in total. The diary will include questions to assess nausea, vomiting, diarrhoea, pain and oral mucositis. An example of the patient diaries offered is supplied. Either the participant or parent will fill in the diary on a daily basis for a minimum of 21 days.
The web-app is an electronic version of the paper diary. Participants will to chose their preferred method. Participants will be given the URL which they can download onto their phone as a web-app. Data provided by participants in the web-app will only be identified by their unique identification number and information will be transferred to an excel spread sheet.
Clinical records including electronic and written records will be reviewed to investigate any febrile episodes and infections for incidence and duration of fever/infection and duration of hospital stay until afebrile for 48 hrs. Any data collected from clinical records will be stored on an excel web sheet which will be kept on an NHS computer. Data on the excel spreadsheet will be identified using their unique identification number. Data will be collected and analysed on an NHS computer. The person collecting the data (the principal investigator) is also a member of the health care team and has access to clinical records as part of routine care.
Participants will be invited to participate in an optional interview exploring their experiences in taking part in the study. This will take up to 45 minutes and can be done over the phone or in person whilst in the hospital. The interviews will be recorded using an encrypted digital audio recorder.
Participants who chose to decline will also be invited to a short optional interview exploring why they chose to decline. This will approximately be a 10 minute discussion which will take place when the participant/their parent disclose they have decided to decline and will only take place if both the participant/parent and interviewer (the chief investigator) is present in the hospital.
- Conditions
- Pediatric Cancer
- Being tested
- Probiotic, Placebo
- Keywords
- pediatric, cancer, malignant haematology, transplant, probiotics, mucositis, infection, supportive care
- Medical subject headings
- Neoplasms, Mucositis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Symprove liquid probiotic
Liquid probiotic supplied by the company Symprove
PlaceboOther
Placebo made of maltdextrin. Will be similar in taste and consistency
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants will start the course of liquid probiotic on the first day of their course of chemotherapy. This can be taken orally, or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows:
1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Participants will start the course placebo on the first day of their course of chemotherapy. This can be taken orally or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows:
1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day
Placebo will be delivered in similar, packaging, appearance and taste. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Proportion of eligible participants successfully recruited to the MaCROS study
Measured: 6 months
Recruitment
Proportion and number of eligible participants successfully recruited to the MaCROS study
Measured: 6 months
Compliance of taking the probiotic/placebo
Proportion of participants who are able to complete the 14 day course
Measured: 6 months
Compliance of filling in the paper/web-app diary
Proportion of participants who are able to fill in and return the diary for 21 days
Measured: 6 months
Cost-benefit evaluation of the study
Cost-benefit analysis of undertaking the study
Measured: 6 months
Secondary outcomes (4)
Incidence of mucositis in both groups
Proportion of participants who develop mucositis in both groups.
Measured: 6 months
Comparison of mucositis in both groups
Mean difference of mucositis (if possible) between both groups
Measured: 6 months
Proportion of participants who develop fever
Proportion of participants who develop fever Mean difference of fever (if possible) between both groups
Measured: 6
Evaluate responsible guardian/participants experience of the MaCROS study
This optional part of the study will be done by undertaking recorded telephone or face to face interview
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start20 Jan 2019 (estimated)
- Primary completion20 Jul 2019 (estimated)
- Study completion20 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomised-controlled feasibility study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Hassan, University of Leeds
- Investigators
- Hadeel Hassan, MBCHB MSc, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785938
- Sponsor's protocol ID
- IRAS PROJECT ID: 246313
- Acronym
- MaCROS
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hassan H, Kinsey S, Phillips B. Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study. Arch Dis Child. 2022 Mar;107(3):259-264. doi: 10.1136/archdischild-2020-319968. Epub 2021 Jun 30.
PubMed 34193407
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer: a Randomised-controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT03785938
- Acronym / sponsor ID
- MaCROS / IRAS PROJECT ID: 246313
- Conditions
- Pediatric Cancer
- Keywords
- pediatric, cancer, malignant haematology, transplant, probiotics, mucositis, infection, supportive care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 20 Jan 2019 (estimated)
- Primary completion
- 20 Jul 2019 (estimated)
- Study completion
- 20 Aug 2019 (estimated)
- First posted
- 24 Dec 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 aim of this study is to evaluate the feasibility of an randomised-controlled trial to investigate the efficacy of liquid probiotics to prevent or reduce mucositis and infection in children diagnosed with cancer who are undergoing treatment with regimes likely to cause mucositis.
Detailed description
TRIAL DESIGN
This will be a single-centre double-blind randomised-controlled feasibility study.
TRIAL SETTING
This study will take place at Leeds Teaching Hospital Trust (LTHT), Leeds UK. Participants will be approached whilst admitted as inpatients (typically the paediatric haematology oncology wards) and during outpatient clinics.
METHOD
Allocation sequence from a randomisation schedule will be generated A screening or trial ID number will be assigned to each participant.
The allocation sequence will be concealed from health care professionals, participants and families. Only the pharmacy team involved in randomisation, allocation will not be blinded to allocation sequence and generation.
Following identification, confirmation of eligibility, consent and allocation of trial ID of the participant, a prescription will be produced and the probiotic or placebo will be allocated accordingly.
Appearance of the intervention and placebo will be similar in appearance, smell and taste. The placebo will include maltdextrin (a polysaccharide). Both the probiotic and placebo will be produced by the company Symprove.
Participants will start the course of probiotic or placebo on the first day of their course of chemotherapy orally, or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows:
1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day Placebo will be delivered in similar, packaging, appearance and taste.
Participants or their parents will be asked to fill in a diary (paper or electronic using a web-app) daily for 21 days in total. The diary will include questions to assess nausea, vomiting, diarrhoea, pain and oral mucositis. An example of the patient diaries offered is supplied. Either the participant or parent will fill in the diary on a daily basis for a minimum of 21 days.
The web-app is an electronic version of the paper diary. Participants will to chose their preferred method. Participants will be given the URL which they can download onto their phone as a web-app. Data provided by participants in the web-app will only be identified by their unique identification number and information will be transferred to an excel spread sheet.
Clinical records including electronic and written records will be reviewed to investigate any febrile episodes and infections for incidence and duration of fever/infection and duration of hospital stay until afebrile for 48 hrs. Any data collected from clinical records will be stored on an excel web sheet which will be kept on an NHS computer. Data on the excel spreadsheet will be identified using their unique identification number. Data will be collected and analysed on an NHS computer. The person collecting the data (the principal investigator) is also a member of the health care team and has access to clinical records as part of routine care.
Participants will be invited to participate in an optional interview exploring their experiences in taking part in the study. This will take up to 45 minutes and can be done over the phone or in person whilst in the hospital. The interviews will be recorded using an encrypted digital audio recorder.
Participants who chose to decline will also be invited to a short optional interview exploring why they chose to decline. This will approximately be a 10 minute discussion which will take place when the participant/their parent disclose they have decided to decline and will only take place if both the participant/parent and interviewer (the chief investigator) is present in the hospital.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomised-controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticParticipants will start the course of liquid probiotic on the first day of their course of chemotherapy. This can be taken orally, or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows: 1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day |
| Placebo | Placebo comparator | Other: PlaceboParticipants will start the course placebo on the first day of their course of chemotherapy. This can be taken orally or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows: 1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day Placebo will be delivered in similar, packaging, appearance and taste. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients between the ages of 1 and 18 treated on paediatric cancer protocols receiving chemotherapy on regimens likely to cause mucositis.
Key exclusion criteria (1 listed)
- Patients who have already started the course of chemotherapy. Patients receiving radiotherapy or surgery alone. Patients diagnosed with an immunodeficiency (excluding IgA). Patients who have previously taken probiotics within the month prior to commencing the course of chemotherapy.
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 |
|---|---|---|
| ProbioticAlso: Symprove liquid probioticLiquid probiotic supplied by the company Symprove | Dietary supplement | Probiotic |
| PlaceboPlacebo made of maltdextrin. Will be similar in taste and consistency | Other | Placebo |
Primary outcome
Recruitment
Time frame: 6 months
Proportion of eligible participants successfully recruited to the MaCROS study
Recruitment
Time frame: 6 months
Proportion and number of eligible participants successfully recruited to the MaCROS study
Compliance of taking the probiotic/placebo
Time frame: 6 months
Proportion of participants who are able to complete the 14 day course
Compliance of filling in the paper/web-app diary
Time frame: 6 months
Proportion of participants who are able to fill in and return the diary for 21 days
Cost-benefit evaluation of the study
Time frame: 6 months
Cost-benefit analysis of undertaking the study
4 secondary outcomes
Incidence of mucositis in both groups
Time frame: 6 months
Comparison of mucositis in both groups
Time frame: 6 months
Proportion of participants who develop fever
Time frame: 6
Evaluate responsible guardian/participants experience of the MaCROS study
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Derived from this study: PubMed 34193407Hassan H, Kinsey S, Phillips B. Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study. Arch Dis Child. 2022 Mar;107(3):259-264. doi: 10.1136/archdischild-2020-319968. Epub 2021 Jun 30.
- Individual participant dataSharing planned: No
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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.
Hadeel Hassan, MBCHB MSc principal investigator
University of Leeds
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Pediatric Cancer, run by University of Leeds.
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 1 inclusion and 1 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 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Hadeel Hassan, MBChB MSc (01133432596 ext. 01133432596, umhh@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 6 months). The study lists 5 primary outcomes in all. 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 NCT03785938, which also lists 1 linked publication.
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 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.