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

NCT04321460 | Completed Phase 3 Results

• 1 other identifier: CT_002_LRG_CAP
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Antibiotic-associated Diarrhea

Keywords

diarrhea

Outcome Measures

Primary Outcomes (2)

• Number of Participants With the Occurrence of Antibiotic-associated Diarrhea (AAD) - Per Protocol (PP) Population

  Diarrhea is defined as loose or watery stool (Type 5-7 according to Bristol Stool Form Scale (BSFS)), 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. BSFS scale includes Types 1 to 7 where Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhea. 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 was assessed in a diary.

  14 days

• Number of Participants With the Occurrence of Antibiotic-associated Diarrhea (AAD) - Intention to Treat (ITT) Population

  Diarrhea is defined as loose or watery stool (Type 5-7 according to Bristol Stool Form Scale (BSFS)), 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. BSFS scale includes Types 1 to 7 where Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhea. 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 was assessed in a diary.

  14 days

Secondary Outcomes (12)

• Mean Number of Bowel Movements Per Day

  14 days

• Number of Participants With the Occurrence of Any Diarrhea

  14 days

• Number of Participants With the Occurrence of C. Difficile-associated Antibiotic-associated Diarrhea (AAD)

  14 Days

• Number of Participants With the Occurrence of Non-C. Difficile-associated AAD

  14 Days

• Mean Duration of Antibiotic-associated Diarrhea (AAD)

  14 days

Study Arms (2)

LRG-002

EXPERIMENTAL

LRG-002 once daily for 14 days

Drug: LRG-002

Placebo

PLACEBO COMPARATOR

Placebo once daily for 14 days

Drug: Placebo

Interventions

LRG-002 DRUG

Capsules containing live lyophilized probiotic bacteria of Lactobacillus genus

LRG-002

Placebo DRUG

Capsules containing placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An Informed Consent Form for study participation voluntarily signed by a patient;
• Male and female subjects, 18 to 65 years of age inclusive;
• 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.
• 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;
• \. 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:
• 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;
• Use of immunosuppressive, immunostimulating and immunomodulating agents including drugs of herbal origin and dietary supplements within 30 days prior to the study start;
• Use of anti-rejection medication after stem cell or solid organ transplant;
• Use of systemic glucocorticosteroids within 8 weeks prior to the study start;
• Use of proton pump inhibitors within 3 months prior to Visit 1;
• Chemotherapy or radiation;
• History of recurrent diarrhea;
• Patient has diarrhea or loose stool within 2 days prior to the study start;
• Patient has severe ARD expected to require an administration of antibiotics therapy for more than 7 days or prescription of additional antibiotics;

Sponsors & Collaborators

• Sandoz: lead

Study Sites (3)

Sandoz Investigative Site

Moscow, Russia

Location

Sandoz Investigative Site

Nizhny Novgorod, Russia

Location

Sandoz Investigative Site

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 25, 2020
• Study Start: October 1, 2020
• Primary Completion: January 4, 2021
• Study Completion: January 4, 2021
• Last Updated: March 14, 2022
• Results First Posted: March 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

RU (3)