Colonisation of Probiotic in Neoplasia.

Conditions

None listed

Brief summary

The purpose of this study is to examine the colonisation potential of an existing probiotic in normal human tissue and cancerous tissue. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are undergoing endoscopy for pre-cancer or cancerous bowel tissue or surgical resection at the Royal Adelaide Hospital or St Andrew's Hospital. Study details Participants will be randomly sorted into two groups according to chance. Each group will take two tablets per day for 14 to 28 days prior to surgery. In one group, the tablets will be probiotic bacteria, and in the other group the tablets will be sugar tablets – however participants will not know which tablets they are taking. The length of time from enrolment in the study until surgery will determine whether participants take tablets for 14 or 28 days. Participants will consent to their surgical samples being tested and a small blood sample sample (9 ml, equivalent to 2 teaspoons) being taken. It is hoped this research will provide information about where probiotics colonise the patient, so novel probiotic-based therapies can be developed.

Gurbatri CR, Radford GA, Vrbanac L, Im J, Thomas EM, Coker C, Taylor SR, Jang Y, Sivan A, Rhee K, Saleh AA, Chien T, Zandkarimi F, Lia I, Lannagan TRM, Wang T, Wright JA, Kobayashi H, Ng JQ, Lawrence M, Sammour T, Thomas M, Lewis M, Papanicolas L, Perry J, Fitzsimmons T, Kaazan P, Lim A, Stavropoulos AM, Gouskos DA, Marker J, Ostroff C, Rogers G, Arpaia N, Worthley DL, Woods SL, Danino T.

2024-01-2083 citations

10.1038/s41467-024-44776-4

Interventions

The probiotic is Escherichia coli Nissle 1917 (EcN), supplied as Mutaflor, Ardeypharm. Each tablet contains at least 5x108 colony forming units (CFU) EcN. Participants will take either 2 tablets of probiotic or placebo (sugar pill) per day for 14 to 28 days, prior to surgery or colonoscopy. Previous studies have administered probiotic for 28 days. This has been shown to be a safe human dose in earlier phase I trials that unfortunately did not measure colonisation as an end-point. The duration o

The probiotic is Escherichia coli Nissle 1917 (EcN), supplied as Mutaflor, Ardeypharm. Each tablet contains at least 5x108 colony forming units (CFU) EcN. Participants will take either 2 tablets of probiotic or placebo (sugar pill) per day for 14 to 28 days, prior to surgery or colonoscopy. Previous studies have administered probiotic for 28 days. This has been shown to be a safe human dose in earlier phase I trials that unfortunately did not measure colonisation as an end-point. The duration of intervention will depend upon the time participants are consented before their procedure (at least 14 days). Adherence of the intervention will be monitored by probiotic tablet return. Mutaflor and placebo tablets are provided for free from Ardeypharm.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Participants must be 18 years or older and undergoing endoscopic polyp removal or surgical resection by the CRC team at the Royal Adelaide Hospital or St Andrew's Hospital in >2 weeks. Participants will most likely have confirmed cancer by pathology but can also be included if pathology is inconclusive but mass is being resected. Previous treatment or radiation to the tumour site is permissible for this study.

Exclusion criteria

Participants must not be currently taking probiotics or antibiotics.

Outcome results