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Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer (MaCROS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03785938
Recruitment Status : Unknown
Verified December 2018 by Hadeel Hassan, University of Leeds.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hadeel Hassan, University of Leeds

Brief 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.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Dietary Supplement: Probiotic Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded randomised-controlled feasibility study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The liquid probiotic/placebo will be blinded by the pharmacy team and LTHT
Primary Purpose: Other
Official Title: Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer: a Randomised-controlled Feasibility Study
Estimated Study Start Date : January 20, 2019
Estimated Primary Completion Date : July 20, 2019
Estimated Study Completion Date : August 20, 2019

Arm Intervention/treatment
Experimental: Probiotic

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

Dietary Supplement: Probiotic
Liquid probiotic supplied by the company Symprove
Other Name: Symprove liquid probiotic

Placebo Comparator: Placebo

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.

Other: Placebo
Placebo made of maltdextrin. Will be similar in taste and consistency




Primary Outcome Measures :
  1. Recruitment [ Time Frame: 6 months ]
    Proportion of eligible participants successfully recruited to the MaCROS study

  2. Recruitment [ Time Frame: 6 months ]
    Proportion and number of eligible participants successfully recruited to the MaCROS study

  3. Compliance of taking the probiotic/placebo [ Time Frame: 6 months ]
    Proportion of participants who are able to complete the 14 day course

  4. 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

  5. Cost-benefit evaluation of the study [ Time Frame: 6 months ]
    Cost-benefit analysis of undertaking the study


Secondary Outcome Measures :
  1. Incidence of mucositis in both groups [ Time Frame: 6 months ]
    Proportion of participants who develop mucositis in both groups.

  2. Comparison of mucositis in both groups [ Time Frame: 6 months ]
    Mean difference of mucositis (if possible) between both groups

  3. Proportion of participants who develop fever [ Time Frame: 6 ]
    Proportion of participants who develop fever Mean difference of fever (if possible) between both groups

  4. Evaluate responsible guardian/participants experience of the MaCROS study [ Time Frame: 6 months ]
    This optional part of the study will be done by undertaking recorded telephone or face to face interview



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients between the ages of 1 and 18 treated on paediatric cancer protocols receiving chemotherapy on regimens likely to cause mucositis.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785938


Contacts
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Contact: Hadeel Hassan, MBChB MSc 01133432596 ext 01133432596 umhh@leeds.ac.uk
Contact: Bob Phillips, MBChB PhD 01904321099 ext 01133432596 bob.phillips@york.ac.uk

Sponsors and Collaborators
University of Leeds
Investigators
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Principal Investigator: Hadeel Hassan, MBCHB MSc University of Leeds
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hadeel Hassan, Clinical Research Fellow, University of Leeds
ClinicalTrials.gov Identifier: NCT03785938    
Other Study ID Numbers: IRAS PROJECT ID: 246313
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hadeel Hassan, University of Leeds:
pediatric
cancer
malignant haematology
transplant
probiotics
mucositis
infection
supportive care
Additional relevant MeSH terms:
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Infections
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases