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 个研究点目标入组 28 人开始时间: 2020年9月17日最近更新: 2024年3月4日

适应症

试验速览

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•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.

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