Testing safety and efficacy of a live bacterial therapy for the treatment of Helicobacter pylori infectio

Phase 1

Completed

• Conditions: Helicobacter pylori infection; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000923965
• Lead Sponsor: Servatus Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Study Completion: 2023-11-28
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified