ANZCTR: ACTRN12618000927224
Date Started: 2017-12-07
Progress - FIH Safety & Efficacy - Recruiting


Study Site:

Northern Cancer Institute, 38 Pacific Hwy, St Leonards NSW 2065


Multibiotic™ is a multi-species probiotic formulation consisting of lactobacilli and bifidobacteria predominately, that has been laboratory and clinically evaluated to improve the stability of the intestinal microbial cohort, especially during and after the administration of pharmaceutical medicines such as antibiotics, proton pump inhibitors, analgesic medications and other.


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

Chemotherapy and radiotherapy are associated with widespread mucositis manifesting as pain, inflammation, dysphagia, diarrhoea, weight loss, rectal bleeding and infection. 

Mucositis is a major dose-limiting side effect of chemotherapy and limits nutritional intake and oral function, resulting in weight loss and malnutrition. Chemotherapy is also detrimental to the friendly bacteria of the gastrointestinal tract causing localized infection and blood infection and almost always leads to immune suppression (neutropenia).

The prevention of cancer therapy-induced mucositis through probiotics has been investigated in randomised clinical trials with some promising results including a significantly decreased incidence of diarrhoea and infectious complications. 

A recent systemic review and meta-analysis of probiotics for prevention of chemoradiotherapy-induced diarrhoea in people with abdominal and pelvic cancers found that probiotics were generally beneficial in treatment-induced diarrhoea.

HREC Date:





The Effect Of Microbiota-Based Interventions And Metformin In Metabolic And Inflammatory Biomarkers In Adults With Type 2 Diabetes Mellitus (T2DM).

4th International Conference on the Science of Nutrition in Medicine and Healthcare. 2014 May 3-5, 2014. Gold Coast, Australia

Date:          2014-05-03

Authors:   Palacios T, Coulson S, Butt H, Vitetta L

Probiotics modify tight-junction proteins in an animal model of nonalcoholic fatty liver disease

Therapeutic Advances in Gastroenterology 2016;9(4):463-472.

Date:          2016-05-01

Authors:   Briskey D, Heritage M, Jaskowoski LA, Peake J, Gobe G, Subramaniam N, Crawford D, Campbell C, Vitetta L

Invitation to speak at Opening Ceremony and Keynote Forum session: The Microbiome - A Universe of Therapeutic Potential.

BIT’s 14th Annual Congress of IDDST June 16-18, 2016. South Korea

Date:          2016-06-16

Authors:   Hall S

Metabolic Disorders: Instruction by the Gut Microbiome

General Practitioner Conference and Exhibition [Sydney] 2016

Date:          2016-01-01

Authors:   Coulson S, Vitetta L

Cancer Treatments, the Intestinal Microbiome and Probiotics.

IPA World Congress Asia Probiota. Singapore. 11-13 October 2017

Date:          2017-10-11

Authors:   Vitetta L

The intestinal microbiome, chemotherapy and adjuvant treatments with probiotics.

Asia-Pacific Journal of Clinical Oncology [Clinical Oncological Society of Australia] November 13-15; 2017, Sydney, Australia.

Date:          2017-11-13

Authors:   Vitetta L, Clarke S, Thomsen M

Intestinal Microbiome and Cancer Treatments/ Gut health Panel.

NIIM Integrative Medicine: The art & science, 4th Annual Symposium 2017 Richmond, Melbourne

Date:          2017-11-24

Authors:   Vitetta L

Adjunctive Treatments for the Prevention of Chemotherapy- and Radiotherapy-Induced Mucositis

Integrative Cancer Therapies. 2018 Dec; 17(4): 1027–1047.

Date:          2018-12-01

Authors:   Thomsen M , Vitetta L

The role of adjuvant probiotics to attenuate intestinal inflammatory responses due to cancer treatments

Beneficial Microbes. 2018 Dec 7;9(6):899-916. doi: 10.3920/BM2017.0172

Date:          2018-12-01

Authors:   Thomsen M, Clarke S, Vitetta L

Interaction of gut microbiota with dysregulation of bile acids in the pathogenesis of nonalcoholic fatty liver disease and potential therapeutic implications of probiotics

J Cell Biochem. 2019 Mar;120(3):2713-2720. doi: 10.1002/jcb.27635. Epub 2018 Nov 15.PMID: 30443932

Date:          2019-03-01

Authors:   Chen J, Thomsen M, Vitetta L


Northern Cancer Institute

Northern Cancer Institute

The Northern Cancer Institute is a group of cancer treatment units where holistic care is given in an environment that is designed to be as pleasant and as comfortable as possible.

Their philosophy of the NCI is to administer chemotherapy with minimal disruption to a normal routine.

For more information visit