A two-stage phase I study to assess safety and efficacy of a live microbial biotherapeutic (SVT-1C4610) as monotherapy for the treatment of Helicobacter pylori infection in otherwise healthy adults.

Servatus Ltd0 sites28 target enrollmentSeptember 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

September 17, 2020

End Date

November 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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).

•\-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.