Clinical Study to Evaluate the Safety and Efficacy of New Probiotic Strains in Health Adults

A Randomized, 5 Arm, Parallel, Placebo Controlled Clinical Study to Evaluate Safety and Efficacy of New Probiotic Strains in Healthy Adults

This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults.

Study Overview

• Status: Recruiting
• Conditions: Safety; Gastrointestinal Health; Respiratory Health
• Intervention / Treatment: Dietary supplement: Cocktail; Dietary supplement: CGI314; Dietary supplement: CSI08; Dietary supplement: MIT411

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lilijana K Besednjak, MD PhD; Phone Number: +38653383466; Email: lilijana.besednjak.kocijancic@zd-go.si

Study Locations

• Slovenia
  • Šempeter Pri Gorici, Slovenia, 5290
    • Recruiting
    • Health Center Nova Gorica
    • Contact: Lilijana K Besednjak, MD PhD; Phone Number: +38653383466; Email: dos.besednjak@zd-go.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent form. Healthy adults aged 18-65.

Exclusion Criteria:

• Presence of a pre-existing adverse events monitored in the study. Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major GI surgery, chronic GI illness, abnormal intestinal anatomy or significant abdominal disorder. Severe chronic illness. Known immunodeficiency. Use of immunosuppressive agents. Presence of severe immunodeficient family members. Pregnancy, 6 months postpartum period or currently breastfeeding. Women of child bearing age planning pregnancy during the course of the study. Participation in another study. Not able to understand and comply with requirements of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cocktail; Subjects will consume 1 capsule containing 2B CFU containing .5B CFU Bacillus subtilis DE111, .5B CFU Bacillus coagulans CGI314, .5B CFU Bacillus megaterium MIT411, and .5B CFU Bacillus clausii CSI08 for 45 days.	Dietary supplement: Cocktail; Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.
Experimental: CGI314; Subjects will consume 1 capsule containing 1B CFU of Bacillus coagulans CGI314 for 45 days.	Dietary supplement: CGI314; Subjects will consume 1B CFU of CGI314 once daily for 45 days.
Experimental: CSI08; Subjects will consume 1 capsule containing 1B CFU of Bacillus clausiiCSI08 for 45 days.	Dietary supplement: CSI08; Subjects will consume 1B CFU of CSI08 once daily for 45 days.
Experimental: MIT411; Subjects will consume 1 capsule containing 1B CFU of Bacillus megaterium MIT411 for 45 days.	Dietary supplement: MIT411; Subjects will consume 1B CFU of MIT411 once daily for 45 days.
No Intervention: Placebo; Subjects will consume 1 capsule containing maltodextrin for 45 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Participants will be asked to note any adverse events that might occur during 45 days study treatment period in the participant diary 1 and 14 days follow-up period in the participant diary 2 and to call the investigator if any clinically significant events occur. The investigator will review the returned participant diaries together with the participant. Based on the adverse events marked in the diaries and written in medical records the number of adverse event occurrences, their nature and causality will be evaluated in all study regimes.	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunomodulation	Evaluate difference in salivary IgA in experimental groups compared to placebo	45 days
Regularity	Evaluate difference in stool consistency according to Bristol stool chart, and regularity of defecation from baseline to day 45 in experimental groups compared to control group and from baseline to end of 14 days follow up period (59 days) in the experimental groups compared to control group. Participants will be asked to track the type of their stool using the bristol stool chart, and times of defecation during the 45 day treatment period and 14 days follow up period in their diaries. On visit 2 and during the follow up phone call the investigator will review the participant diary together with the participant.	45 days
GI Health	Assess number of days with gastrointestinal problems in experimental groups compared to placebo.	45 days
Respiratory Health	Assess number of days with respiratory infections in experimental groups compared to placebo.	45 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Health	Assess the change in blood lipids from baseline to finish in experimental groups compared to plcaebo	45 days
Inflammation	Assess the change in cytokines in experimental groups compared to placebo.	45 days

Collaborators and Investigators

• Sponsor: Deerland Enzymes
• Investigators: Principal Investigator: Lilijana K Besednjak, MD PhD, Health Center Nova Gorica

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Probiotics; Immunomodulation; Antioxidant; Respiratory Health; Gastrointestinal Health; Chelation of heavy metals
• Other Study ID Numbers: Pro5Safe

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No