Phase 1 clinical trial evaluating whether probiotic supplementation prevents chemotherapy-induced diarrhoea and other intestinal adverse effects in cancer patients.

The safety and tolerability of a multi-species probiotic formulation in chemotherapy-induced intestinal mucositis/diarrhoea/neutropenia: an exploratory end-point pilot study

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000927224

Enrollment

Registered

2018-05-31

Start date

2019-02-28

Completion date

2019-12-31

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to test the safety and tolerability of the MultiBiotic probiotic formulation before starting chemotherapy and until the end of treatment. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer and have not yet commenced chemotherapy. Study details Patients who decide to take part in this trial will be given probiotic (friendly gut bacteria) capsules to be taken daily before and during the duration of the chemotherapy. The probiotic has been developed to support gastrointestinal health. It contains three species of Lactobacilli, three species of Bifidobacterium and one species of Streptococcus bacteria. Participants will be asked about their general wellbeing at the beginning and at the end of the study. They will also be asked to keep a record of intestinal symptoms. A stool and a blood test will be required at beginning and at the end of the study. Chemotherapy is associated with mucositis manifesting as pain, inflammation, diarrhoea, weight loss, and infection. It is hoped that this research will help improve the general wellbeing of patients during chemotherapy.

Interventions

Intervention: MultiBiotic probiotic formulation containing per capsule: Lactobacillus rhamnosus (Med 26) 9 billion CFU Lactobacillus acidophilus (Med 27) 3.75 billion CFU Lactobacillus plantarum (Med 25) 1.575 billion CFU Bifidobacterium animalis spp. lactis (Med 13) 3 billion CFU Bifidobacterium breve (Med 12) 1.75 billion CFU Bifidobacterium bifidum (Med 11) 500 million CFU Streptococcus thermophilus (Med 51) 1.5 billion CFU Total 21.075 Billion CFU* / 1 capsule Dosage: 2 capsules twice dail

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Adult patient diagnosed with cancer and who are chemotherapy naïve or about to commence a new chemotherapy regimen due to disease progression Life expectancy more than 12 months Absence of any psychological, familial, sociological or geographical conditions, which could potentially hamper compliance with the study protocol and follow-up schedule; Willingness to comply with the study. Signed and written informed consent

Exclusion criteria

Active infection treated by antibiotic therapy Ileostomy Hypersensitivity to study drug Any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years. Serious concomitant systemic disorders or diseases incompatible with the study Patient has a history of primary psychological disorder Illicit drug use

Outcome results