Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.
Condition: Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Intervention: LRG-002; Placebo
Intervention description: Capsules containing live lyophilized probiotic bacteria of Lactobacillus genus; Capsules containing placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 520.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: diarrhea

Summary:

      The goal of this study was to investigate the efficacy and safety of LRG-002 investigational
      medicinal product, capsules (Lek d.d., Slovenia) in comparison with placebo, as an adjunct
      treatment for prophylaxis of antibiotic-associated diarrhea (AAD) in patients with acute
      respiratory diseases (ARDs) receiving a standard antimicrobial therapy.
    

Eligibility criteria:

        Patients will be considered eligible for study participation if they meet the following
        inclusion criteria:

          1. An Informed Consent Form for study participation voluntarily signed by a patient;

          2. Male and female subjects, 18 to 65 years of age inclusive;

          3. Antibacterial treatment for active ARDs started/to be started on the first day of the
             study (7-day course of oral beta-lactam antibiotic). Only one AB should be used per
             subject, in an outpatient setting. Diagnostic procedures of ARD and the prescription
             of antibiotic therapy should be completed before signing of the Informed Consent Form.

          4. Female patients will be considered as eligible for study participation if they are:
             Unable to become pregnant or Capable of childbirth, but with negative pregnancy test
             at the screening visit, and the patient agrees to continuously and properly use one a
             following suitable methods of contraception Male participants,. together with their
             partner, are to use appropriate contraception during the entire study period starting
             from signing of the Informed Consent Form and until the study end, and for 30 days
             after study completion;

        6. The ability to understand the information about the clinical study, readiness to comply
        with the study protocol requirements, ability to take the investigational products and
        evaluate symptoms on his (or her) own using diary/questionnaires as per protocol; 7.
        Ability to maintain the habitual lifestyle throughout the study, including diet. 8. Willing
        not to consume any products containing probiotics during participation in the clinical
        trial. 9. Willing not to take part in any other study during the present trial.

        Patients will not be eligible for study enrollment if they have one or more of the
        following criteria:

          1. Any therapy (including medications, medical devices and dietary supplements) that can
             influence the stool consistency, according to the Investigator's opinion, should not
             be used within 14 days prior to Visit 1;

          2. Use of immunosuppressive, immunostimulating and immunomodulating agents including
             drugs of herbal origin and dietary supplements within 30 days prior to the study
             start;

          3. Use of anti-rejection medication after stem cell or solid organ transplant;

          4. Use of systemic glucocorticosteroids within 8 weeks prior to the study start;

          5. Use of proton pump inhibitors within 3 months prior to Visit 1;

          6. Chemotherapy or radiation;

          7. History of recurrent diarrhea;

          8. Patient has diarrhea or loose stool within 2 days prior to the study start;

          9. Patient has severe ARD expected to require an administration of antibiotics therapy
             for more than 7 days or prescription of additional antibiotics;

         10. Use of antimicrobials within 3 months prior to the study start;

         11. Use of yeast/probiotic/fermented products within 2 weeks prior to the first visit;

         12. Known allergy/hypersensitivity to the investigational medicinal product in the medical
             history;

         13. Immunocompromised patients;

         14. Known digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory
             bowel disease, celiacia, pancreatitis, motility disorders etc.) and/or
             gastrointestinal surgery;

         15. Known irritable bowel syndrome;

         16. Known small intestinal bacterial overgrowth;

         17. Patient has pyrexia of more than 38°C;

         18. Pregnant and/or breastfeeding women;

         19. Participation in other clinical trials of medicinal products or medical devices at the
             screening Visit or within 30 days before the screening Visit;

         20. Surgical intervention within 30 days before the screening visit or planned surgical
             treatment during the trial (before a follow-up visit is completed), including
             diagnostic procedures or inpatient stay;

         21. Known or suspected alcohol and/or drug addiction;

         22. A suspected low compliance or incapability of the patient to perform the procedures
             and comply with restrictions according to the trial protocol (e.g., due to mental
             disorders);

         23. Potential for translocation of probiotic across bowel wall (Presence of an active
             bowel leak, acute abdomen, active intestinal disease including colitis, or significant
             bowel dysfunction; presence of neutropenia or anticipation of neutropenia after
             chemotherapy; radiation therapy);

         24. Any disorders of cardiovascular, renal, hepatic, gastrointestinal, endocrine and
             nervous systems, or other conditions/diseases which, in the Investigator's opinion,
             may render study participation unsafe for a patient or may affect a test result.