Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer

NCT03785938 | Unknown

• 1 other identifier: IRAS PROJECT ID: 246313
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric Cancer

Keywords

pediatric; cancer; malignant haematology; transplant; probiotics; mucositis; infection; supportive care

Outcome Measures

Primary Outcomes (5)

• Recruitment

  Proportion of eligible participants successfully recruited to the MaCROS study

  6 months

• Recruitment

  Proportion and number of eligible participants successfully recruited to the MaCROS study

  6 months

• Compliance of taking the probiotic/placebo

  Proportion of participants who are able to complete the 14 day course

  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

  6 months

• Cost-benefit evaluation of the study

  Cost-benefit analysis of undertaking the study

  6 months

Secondary Outcomes (4)

• Incidence of mucositis in both groups

  6 months

• Comparison of mucositis in both groups

  6 months

• Proportion of participants who develop fever

  6

• Evaluate responsible guardian/participants experience of the MaCROS study

  6 months

Study Arms (2)

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

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.

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Liquid probiotic supplied by the company Symprove

Also known as: Symprove liquid probiotic

Probiotic

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead

Related Publications (1)

• 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.

  PMID: 34193407 DERIVED

MeSH Terms

Conditions

Neoplasms; Mucositis; Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hadeel Hassan, MBCHB MSc

  University of Leeds

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadeel Hassan, MBChB MSc

CONTACT

01133432596; umhh@leeds.ac.uk

Bob Phillips, MBChB PhD

CONTACT

01904321099; bob.phillips@york.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The liquid probiotic/placebo will be blinded by the pharmacy team and LTHT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Model Details: Double blinded randomised-controlled feasibility study

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 24, 2018
• Study Start: January 20, 2019
• Primary Completion: July 20, 2019
• Study Completion: August 20, 2019
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share