Clinical trial · Interventional
Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer
Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer: a Randomised-controlled Feasibility Study
NCT03785938CI-TRIAL-00036260MaCROSunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Probiotic | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Probiotic
- description
- 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
- interventionNames
- Dietary Supplement: Probiotic
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Other: Placebo
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHassan 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