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

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758845
• Other study ID #: Pro5Safe
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: May 2021

Study information

• Verified date: February 2021
• Source: Deerland Enzymes
• Contact: Lilijana K Besednjak, MD PhD
• Phone: +38653383466
• Email: lilijana.besednjak.kocijancic[@]zd-go.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Health
• Respiratory Health
• Safety

Intervention

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.
• CGI314
Subjects will consume 1B CFU of CGI314 once daily for 45 days.
• CSI08
Subjects will consume 1B CFU of CSI08 once daily for 45 days.
• MIT411
Subjects will consume 1B CFU of MIT411 once daily for 45 days.

Locations

Country	Name	City	State
Slovenia	Health Center Nova Gorica	Šempeter Pri Gorici

Sponsors (1)

Lead Sponsor	Collaborator
Deerland Enzymes

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Health	Assess the change in blood lipids from baseline to finish in experimental groups compared to plcaebo	45 days
Other	Inflammation	Assess the change in cytokines in experimental groups compared to placebo.	45 days
Primary	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	Immunomodulation	Evaluate difference in salivary IgA in experimental groups compared to placebo	45 days
Secondary	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
Secondary	GI Health	Assess number of days with gastrointestinal problems in experimental groups compared to placebo.	45 days
Secondary	Respiratory Health	Assess number of days with respiratory infections in experimental groups compared to placebo.	45 days