None listed
Conditions
Brief summary
The aim of this study is to evaluate safety and efficacy of SVT-1C4610 as a monotherapy treatment for eradicating H. pylori infection. The treatment consists of carefully selected bacterial species that have demonstrated bactericidal activity against H. pylori in vitro. Bacteria are part of a healthy gut microbiome, including the stomach. An altered balance of bacteria in the gut is observed in people with H. pylori infection. When H. pylori is eradicate from the stomach, the gastric microbiota is observed to rebalance to a more healthy state. Proposed mechanisms for the bacterial species in eradicating H. pylori infection include competition for adhesion sites on the gastric epithelium, improved gastric mucosal barrier function, production of antimicrobial peptides against H. pylori, down regulation of inflammatory cytokines that are induced by H. pylori and by binding to H. pylori forming complexes that can be removed from the stomach via the gastrointestinal tract. There is evidence that monotherapy with high doses of beneficial bacteria is successful in eradicating H. pylori in a certain number of cases and several studies have found a greater response to eradicating H. pylori when standard treatment is given together with beneficial bacteria. This study will help determine how effective a high dose of SVT-1C4610 is as a stand-alone therapy in eradicating H. pylori and reducing symptoms.
Interventions
This is a two stage - phase 1 study. Stage 2 (30 participants) will only proceed if stage 1 (13 participants) is deemed successful.
Participants will be provided with 14 x 250ml bottles of the investigational medication. Participants will be clearly instructed to measure 60 mL of SVT-1C4610 into the measuring cup provided and consume immediately each morning and evening on an empty stomach and advised not to consume any food or drink for 30 minutes post dose. Each 60 mL dose of SVT-1C469 contai
This is a two stage - phase 1 study. Stage 2 (30 participants) will only proceed if stage 1 (13 participants) is deemed successful. Participants will be provided with 14 x 250ml bottles of the investigational medication. Participants will be clearly instructed to measure 60 mL of SVT-1C4610 into the measuring cup provided and consume immediately each morning and evening on an empty stomach and advised not to consume any food or drink for 30 minutes post dose. Each 60 mL dose of SVT-1C469 contains 1.9 x 10^12 (1.9 trillion) colony forming units (CFU) of bacterial species. They will be instructed to start consuming the SVT-1C469 at the clinic during Visit 1 and again that evening. The Participants are required to record their adherence to the intervention in a participant diary, along with any adverse events and any concomitant medications taken during the study period. At the end of the 28 days participants will return to the clinic with their participant diary. The participants will be provided a second diary for the following 28 days and they will continue to record any adverse events in the diary until their next visit. Stage 2 will only proceed if there are no serious adverse events reported and the principal investigator deems it safe to do so, and at least 3 of the 13 participants are responders. A responder is defined as a participant that has a reduction in their urea breath test of greater than or equal to 38% on day 60 compared to baseline.
Sponsors
Servatus Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Male and female participants aged 18 years or older, capable of providing own informed consent and able to attend the Princess Alexandra Hospital as required for study visits; - Determined by medical history and clinical judgement of the investigator to be medically healthy; - Females of childbearing potential (FOCBP) must have a negative pregnancy test at baseline; - Females (FOCBP) and males must use contraception while on the study; -Positive for H. pylori infection at screening confirmed by a positive urea breath test; Able to adhere to the medication guidelines prior to undertaking the urea breath test (if applicable) that includes: -No antibiotics or bismuth containing medication (Nexium, Klacid, Pepto-Bismol) use 4 weeks prior to the test; -No acid suppressant medications (Losec, Somac, Nexium, Pariet) use 7 days prior to the test (can be resumed after testing if required); -No short-term acid suppressant medications (Zantac, Nizatidine, Mylanta, Rennies) within 48 hours prior to the test (can be resumed after testing if required).
Exclusion criteria
-Immunocompromised Participants, or those with known or suspected history of immunodeficiency, as determined by medical history review, physical examination and/or laboratory findings; -History of severe adverse reaction including but not limited to anaphylaxis (or a suspicion of this by the Investigator) to any products containing bacterial species, any component of SVT-1C4610 or any antibiotic commonly used to treat bacterial infections; -Any history of anti–tumour necrosis factor (TNF) treatment or other Immunosuppressant medications; -Current use of corticosteroids: equal to or greater than 15mg/daily of oral prednisolone daily (or equivalent) and/or history of intermittent corticosteroids usage equal to or greater 40mg/daily of oral prednisolone (or equivalent) of >3 days in the last 3 months; -Use of antibiotics within 4 weeks of the Baseline Visit (Day 0) and for the study duration; -Females who are pregnant or breastfeeding or planning on becoming pregnant for the study period (treatment and follow-up periods); -Any condition that, in the opinion of the Investigator, contraindicates participation in this study or poses an additional risk to the Participant including any known and/or suspected medical or psychiatric conditions, history of active peptic ulcer disease and/or gastroesophageal disease, severe gastritis or presence of alarm symptoms.
Outcome results
None listed