None listed
Conditions
Brief summary
This study is aiming to explore the effect of a synbiotic formulation (combination of prebiotic and probiotic) on gastrointestinal chemotherapy symptoms in patients with solid tumours. Who is it for? You may be eligible for this study if you are aged 50 to 75 years old, have a solid tumour cancer, and are starting chemotherapy treatment. Study details Study participants will be randomly allocated (by chance) to one of two arms. One group will receive a synbiotic formulation taken twice daily for two weeks at the start of the first chemotherapy cycle, while the other group receives a placebo formulation taken twice daily for two weeks at the start of the first chemotherapy cycle. After a two week break from treatment, a second chemotherapy round will take place, with group one given a placebo formulation and group two given a synbiotic formulation. This sequence will repeat in the third and fourth chemotherapy cycles. Incidence and severity of gastrointestinal symptoms will be monitored using FACT-C questionnaire , Bristol stool score and LPS assay. We hope that this research will improve health outcomes such as gastrointestinal symptoms alleviation from chemotherapy and better tolerability of chemotherapy leading to improved quality of life.
Interventions
Synbiotic formulation (combination of prebiotic and probiotic) will be used in this pilot study. The study synbiotic formulation consists of prebiotic sugarcane flour and Bacillus Coagulans (probiotic). One dose of formulation contains Bacillus coagulans spores 2 Billion CFU and 1.5g prebiotic sugar cane flour.
This study will recruit 40 participants and will be randomly allocated into two groups receiving synbiotic treatment or placebo in different order during their chemotherapy treatment. Pat
Synbiotic formulation (combination of prebiotic and probiotic) will be used in this pilot study. The study synbiotic formulation consists of prebiotic sugarcane flour and Bacillus Coagulans (probiotic). One dose of formulation contains Bacillus coagulans spores 2 Billion CFU and 1.5g prebiotic sugar cane flour. This study will recruit 40 participants and will be randomly allocated into two groups receiving synbiotic treatment or placebo in different order during their chemotherapy treatment. Patients receiving chemotherapy typically undergo several 4-week cycles of treatment. Therefore, group 1 will receive the synbiotic preparation for the first two weeks of their first chemotherapy cycle, followed by a washout period in the third and fourth week of the cycle. During the first two weeks of the second chemotherapy cycle group 1 will receive the placebo followed again, by two weeks of washout. This sequence will be repeated for the third and fourth chemotherapy cycles. Group 2 will receive the placebo in the first chemotherapy cycle followed by wash out and the synbiotic preparation in second chemotherapy cycle, this sequence will repeat in the third and fourth cycles. The synbiotic formulation will be taken by mouth twice daily for two weeks from commencement of chemotherapy cycle. Participants will be instructed by a research Nurse on how to consume the synbiotic formulation/placebo. Participants need to stir one sachet of synbiotics formulation or placebo into a glass of water and consume 30 minutes before food each morning and night, ensuring it is consumed immediately in suspended form. The study participants will be asked to return the empty sachets along with the questionnaires in order to monitor the adherence of the intervention.
Sponsors
KFSU Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• Adult patients with solid tumour cancers starting chemotherapy treatment. • Age range: 50-75 years, with a life expectancy of more than 12 months. • Able to take food and fluid orally. • Able to comply with all study requirements.
Exclusion criteria
• Active infection treated by antibiotic therapy. • Ileostomy. • Hypersensitivity to study synbiotics. • History of major psychiatric illness • Any significant psychological, familial, sociological or geographical conditions, which could potentially hamper compliance with study protocol and follow-up schedule. • Participants with low English proficiency.
Outcome results
None listed