Bacterial Infections Clinical Trial
Official title:
Phase 1 Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability and Acceptability of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Female Volunteers
This is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose escalation, clinical trial enrolling 24 healthy participants. The main subject is to investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the acceptability of the capsule.
Bacterial vaginosis (BV) is the most common vaginal syndrome frequently found in women. BV is currently mainly treated with antibiotics. However, antibiotic administration can cause various side effects. And one of them is destroying the normal bacteria in the vagina, affecting the balance of the vaginal flora, increasing the likelihood of bacterial vaginosis recurrence, and causing drug resistance of bacteria. Therefore, the importance of fundamental treatment with the recovery of balance in normal vaginal flora is being recognized increasingly. The study drug for this trial, LABTHERA-001, has been derived from the bacteria Lactobacillus plantarum ATG-K2. Administration of the ATG-K2 strain will temporarily colonize the vagina to encourage a more normal microbiome. The main goals of this study are 1. to determine whether LABTHERA-001 is safe and well tolerated in healthy adult women. And 2. to investigate the acceptability of the LABTHERA-001 capsule or matching placebo by completing a satisfaction evaluation questionnaire. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03726216 -
Xydalba Utilization Registry in France
|
||
Completed |
NCT03605498 -
OR PathTrac (Tracking Intra-operative Bacterial Transmission)
|
||
Withdrawn |
NCT05269121 -
Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
|
Phase 1/Phase 2 | |
Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
Recruiting |
NCT02074865 -
Children's Antibiotic Resistant Infections in Low Income Countries
|
N/A | |
Completed |
NCT01689207 -
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
|
Phase 1 | |
Completed |
NCT01932034 -
Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software
|
N/A | |
Completed |
NCT01412801 -
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
|
Phase 2 | |
Not yet recruiting |
NCT01159470 -
The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children
|
N/A | |
Completed |
NCT00983255 -
Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)
|
Phase 1 | |
Completed |
NCT00678106 -
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
|
Phase 1 | |
Completed |
NCT00799591 -
French Study In ICU Patients Treated With Tigecycline
|
N/A | |
Completed |
NCT00478855 -
Tazocin Intervention Study
|
Phase 4 | |
Completed |
NCT01074775 -
Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection
|
N/A | |
Terminated |
NCT00431028 -
Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03634904 -
Serum Ceftazidime Concentrations in Hemodialysis Patients
|
N/A | |
Recruiting |
NCT05684705 -
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
|
Phase 1 | |
Recruiting |
NCT03858387 -
PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
|
||
Enrolling by invitation |
NCT04764058 -
Efficacy and Safety of Colistin Based Antibiotic Therapy
|
Phase 1/Phase 2 | |
Recruiting |
NCT06319235 -
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
|
Phase 1/Phase 2 |