Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used... | NCT04321460

NCT04321460

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
LRG-002	Experimental	LRG-002 once daily for 14 days	Drug: LRG-002
Placebo	Placebo Comparator	Placebo once daily for 14 days	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LRG-002	Drug	Capsules containing live lyophilized probiotic bacteria of Lactobacillus genus	LRG-002

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mean Number of Bowel Movements Per Day	Bowel movements were assessed based on the data of patient's diary	14 days
Number of Participants With the Occurrence of Any Diarrhea	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.

Eligibility Module

Eligibility Criteria

Patients will be considered eligible for study participation if they meet the following inclusion criteria:

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;

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:

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;
Use of antimicrobials within 3 months prior to the study start;
Use of yeast/probiotic/fermented products within 2 weeks prior to the first visit;
Known allergy/hypersensitivity to the investigational medicinal product in the medical history;
Immunocompromised patients;
Known digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory bowel disease, celiacia, pancreatitis, motility disorders etc.) and/or gastrointestinal surgery;
Known irritable bowel syndrome;
Known small intestinal bacterial overgrowth;
Patient has pyrexia of more than 38°C;
Pregnant and/or breastfeeding women;
Participation in other clinical trials of medicinal products or medical devices at the screening Visit or within 30 days before the screening Visit;
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;
Known or suspected alcohol and/or drug addiction;
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);
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);
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.

Facility	Status	City	State	ZIP	Country	Contacts
Sandoz Investigative Site		Moscow			Russia
Sandoz Investigative Site

ID	Title	Description
FG000	LRG-002	LRG-002 once daily for 14 days
FG001	Placebo	Placebo once daily for 14 days

ID	Title	Description
BG000	LRG-002	LRG-002 once daily for 14 days
BG001	Placebo	Placebo once daily for 14 days

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	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.	The per protocol (PP) population included all randomized participants who completed participation in the study in accordance with the protocol (have completed the prescribed period of treatment and follow-up without significant deviations from the protocol)	Posted		Count of Participants		Participants		14 days

Adverse Events Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 23, 2020	Dec 29, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Mar 11, 2021	Dec 29, 2021	SAP_001.pdf

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
OG000	LRG-002	LRG-002 once daily for 14 days
OG001	Placebo	Placebo once daily for 14 days