Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.

Overview

The goal of this study is 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.

Full Title of Study: “Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel-group Efficacy and Safety Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 15, 2020

Detailed Description

A prospective, multi-center, double-blind, randomized, parallel-group clinical study.

The study will comprise the following periods:

I. Screening + randomization + treatment initiation: Visit 1 (Day 1) II. Blinded treatment with LRG-002 or matching placebo in antibiotic-treated patients for a total of 14 days.

Interventions

  • Drug: LRG-002
    • Capsules containing live lyophilized probiotic bacteria of Lactobacillus genus
  • Drug: Placebo
    • Capsules containing placebo

Arms, Groups and Cohorts

  • Experimental: LRG-002
    • LRG-002 once daily for 14 days
  • Placebo Comparator: Placebo
    • Placebo once daily for 14 days

Clinical Trial Outcome Measures

Primary Measures

  • Frequency of occurrence of AAD
    • Time Frame: 14 days
    • AAD (antibiotic-associated diarrhea) is defined as diarrhea associated with the antibiotic use caused by C. difficile or of otherwise not identified etiology, upon analysis of stool samples and differential diagnostics according to investigator’s judgment. Diarrhea is defined as loose or watery stool (Type 5-7 according to Bristol Stool Form Scale) three times a day (frequent bowel movements with formed stool is not considered as diarrhea) in accordance with WHO criteria; based on the diary data (BSFS) and confirmation of AAD by the investigator.. Diarrhea is assessed in a diary

Secondary Measures

  • Mean number of bowel movements per day
    • Time Frame: 14 days
    • Bowel movements will be assessed based on the data of patient’s diary
  • Incidence of any diarrhea
    • Time Frame: 14 days
    • Incidence of any diarrhea will be assessed based on the data of patient’s diary
  • Mean duration of AAD
    • Time Frame: 14 days
    • The duration of AAD (the time from the onset of AAD to the normalization of stool form according to BSFS (types 1, 2, 3 and 4) and the presence of normal stool within 48 hours)) will be assessed based on the data of patient’s diary
  • Mean duration of any diarrhea
    • Time Frame: 14 days
    • The duration of any diarrhea (the time from the onset of diarrhea to the normalization of stool form according to BSFS (types 1, 2, 3 and 4) and the presence of normal stool within 48 hours)) will be assessed based on the data of patient’s diary
  • Change in stool consistency
    • Time Frame: 14 days
    • The changes in stool consistency (according to Bristol Stool Form Scale) will be assessed based on the data of patient’s diary
  • Number of gastrointestinal symptoms by severity
    • Time Frame: 14 days
    • The occurrence and severity of gastrointestinal symptoms, including nausea, vomiting, flatulence, abdominal pain and decreased appetite will be assessed based on the data of patient’s diary
  • Incidence of C. difficile-associated AAD
    • Time Frame: 14 Days
    • Incidence of C. difficile-associated AAD will be assessed based on the data of stool analysis
  • Incidence of non-C. difficile-associated AAD
    • Time Frame: 14 Days
    • Incidence of non-C. difficile-associated AAD will be assessed based on the data of stool analysis
  • Change from baseline in body weight
    • Time Frame: Baseline, Day 15
    • Change from baseline in body weight will be assessed based on thet clinical data
  • Hospitalization rate
    • Time Frame: 14 days
    • Hospitalization rate will be assessed based on the clinical data
  • Number of days of using standard symptomatic therapy
    • Time Frame: 14 days
    • The number of days of using standard symptomatic therapy (as “rescue medication”) to relieve symptoms of acute diarrhea will be assessed based on the clinical data
  • Number of patients using standard symptomatic therapy
    • Time Frame: 14 days
    • The number of patients using standard symptomatic therapy (as “rescue medication”) to relieve symptoms of acute diarrhea will be assessed based on the clinical data

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sandoz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Novartis Pharmaceuticals, +41-61-3241111, novartis.email@novartis.com

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