NCT02076139

Brief Summary

This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers with or without tuberculosis infection. This trial aims to study the effect of the probiotic Nyaditum resae® at the level of specific Regulatory T cells (Treg) memory cells one week after the first administration and the global tolerability of the treatment. Nyaditum resae® is a preparation in the form of drinkable vials containing heat-killed environmental mycobacteria. The overall objective of the study is the effect of Nyaditum resae® on immunity, which could reduce the risk of developing active tuberculosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

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 20, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 31, 2018

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

February 20, 2014

Last Update Submit

October 30, 2018

Conditions

Tuberculosis

Keywords

tuberculosistregtoleranceprobioticmycobacteria

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Specific Treg memory cells at week 1

    Median increase of specific Treg memory cells at week 1.

    From Baseline to Week 1

  • Global tolerability of Nyaditum resae ®, proportion of participants with adverse events related to study treatment.

    Proportion of patients presenting adverse events related to study treatment.

    Baseline to week 6

Secondary Outcomes (4)

  • Local tolerability (gastrointestinal duct), proportion of participants with gastrointestinal adverse events related to study treatment.

    Baseline to week 6

  • Systemic tolerability (vital signs, physical exam, laboratory tests), proportion of participants with systemic adverse events related to study treatment.

    Baseline to week 6

  • Change from Baseline in Specific Treg memory cells at week 2

    From Baseline to Week 2

  • Change from Baseline in Specific Treg memory cells at month 12

    From Baseline to Month 12

Study Arms (3)

Nyaditum resae® 10e4

EXPERIMENTAL

The subjects will receive 1 drinkable vial (4mL) per day during 14 days. Each vial contains 10e4 Colony-forming units (CFUs) of Nyaditum resae®.

Dietary Supplement: Nyaditum resae® 10e4

Nyaditum resae® 10e5

EXPERIMENTAL

The subjects will receive 1 drinkable vial (4mL) per day during 14 days. Each vial contains 10e5 CFUs of Nyaditum resae®.

Dietary Supplement: Nyaditum resae® 10e5

Placebo

PLACEBO COMPARATOR

The subjects will receive 1 drinkable vial (4mL) of distilled water per day during 14 days.

Other: Distilled water

Interventions

Nyaditum resae® 10e4DIETARY_SUPPLEMENT
Nyaditum resae® 10e4
Nyaditum resae® 10e5DIETARY_SUPPLEMENT
Nyaditum resae® 10e5
Distilled waterOTHER
Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent before starting the selection process.
  • Women and men ≥ 18 years.
  • Availability to meet the requirements of the protocol.

You may not qualify if:

  • HIV positive.
  • Known immunodeficiencies.
  • Pregnancy and maternal lactation.
  • Active tuberculosis.
  • Enrollment in another clinical trial.
  • Chronic administration of: methotrexate, azathioprine, cyclophosphamide, oral corticosteroids and other immunosuppressive therapies / immunomodulatory .
  • Administration of blood products or blood derivatives during the 6 months prior to randomization.
  • Detection by the researcher lack of knowledge or willingness to participate and fulfill all the requirements of the protocol.
  • Any other finding that the investigator's opinion, could jeopardize the performance of the protocol or significantly influence the results or interpretation of the effects of probiotic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias I Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

  • Tukvadze N, Cardona P, Vashakidze S, Shubladze N, Avaliani Z, Vilaplana C, Cardona PJ. Development of the food supplement Nyaditum resae as a new tool to reduce the risk of tuberculosis development. Int J Mycobacteriol. 2016 Dec;5 Suppl 1(Suppl 1):S101-S102. doi: 10.1016/j.ijmyco.2016.09.073. Epub 2016 Nov 14.

    PMID: 28043488DERIVED

MeSH Terms

Conditions

TuberculosisMycobacterium Infections

Condition Hierarchy (Ancestors)

Actinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Eva Montané, MD, PhD

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2014

First Posted

March 3, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2015

Last Updated

October 31, 2018

Record last verified: 2017-09

Locations

ES(1)