NCT04758845

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 11, 2021

Last Update Submit

February 15, 2021

Conditions

Gastrointestinal HealthRespiratory HealthSafety

Keywords

ProbioticsGastrointestinal HealthRespiratory HealthImmunomodulationAntioxidantChelation of heavy metals

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Immunomodulation

    45 days

  • Regularity

    45 days

  • GI Health

    45 days

  • Respiratory Health

    45 days

Other Outcomes (2)

  • Heart Health

    45 days

  • Inflammation

    45 days

Study Arms (5)

Cocktail

EXPERIMENTAL

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

CGI314

EXPERIMENTAL

Subjects will consume 1 capsule containing 1B CFU of Bacillus coagulans CGI314 for 45 days.

Dietary Supplement: CGI314

CSI08

EXPERIMENTAL

Subjects will consume 1 capsule containing 1B CFU of Bacillus clausiiCSI08 for 45 days.

Dietary Supplement: CSI08

MIT411

EXPERIMENTAL

Subjects will consume 1 capsule containing 1B CFU of Bacillus megaterium MIT411 for 45 days.

Dietary Supplement: MIT411

Placebo

NO INTERVENTION

Subjects will consume 1 capsule containing maltodextrin for 45 days.

Interventions

CocktailDIETARY_SUPPLEMENT

Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.

Cocktail
CGI314DIETARY_SUPPLEMENT

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

CGI314
CSI08DIETARY_SUPPLEMENT

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

CSI08
MIT411DIETARY_SUPPLEMENT

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

MIT411

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Center Nova Gorica

Šempeter pri Gorici, 5290, Slovenia

RECRUITING

Related Publications (1)

  • Rea K, Colom J, Simon EA, Khokhlova E, Mazhar S, Barrena M, Enrique M, Martorell P, Perez BA, Tortajada M, Phipps C, Deaton J. Evaluation of Bacillus clausii CSI08, Bacillus megaterium MIT411 and a Bacillus cocktail on gastrointestinal health: a randomised, double-blind, placebo-controlled pilot study. Benef Microbes. 2023 Apr 18;14(2):165-182. doi: 10.3920/BM2022.0117. Epub 2023 Apr 7.

    PMID: 37026366DERIVED

Study Officials

  • Lilijana K Besednjak, MD PhD

    Health Center Nova Gorica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilijana K Besednjak, MD PhD

CONTACT

+38653383466lilijana.besednjak.kocijancic@zd-go.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 17, 2021

Study Start

February 11, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

SL(1)