NCT02581579

Brief Summary

This is a doble-blind, masked, compared with placebo clinical trial in pediatric population in contact with tuberculosis with or without tuberculosis infection. This trial aims to study the effect of the probiotic Nyaditum resae® at the level of specific Treg memory cells eight weeks after the first administration, and the global tolerability of the treatment. Nyaditum resae® is a preparation in the form of capsules containing heat-killed environmental mycobacteria Mycobacterium manresensis. 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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

October 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 9, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2019

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

October 19, 2015

Last Update Submit

December 3, 2019

Conditions

Tuberculosis

Keywords

TuberculosisTregsToleranceProbioticMycobacteria

Outcome Measures

Primary Outcomes (2)

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

    From Baseline to Week 8

  • Proportion of patients presenting adverse events related to study treatment.

    From Baseline to Week 8

Secondary Outcomes (2)

  • Proportion of participants presenting gastrointestinal adverse events related to study treatment.

    Baseline to week 8

  • Proportion of participants presenting systemic adverse events related to study treatment.

    Baseline to week 8

Study Arms (2)

Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis

ACTIVE COMPARATOR

Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis

Dietary Supplement: Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis

Placebo

PLACEBO COMPARATOR

MANITOL CAPSULES

Other: Placebo

Interventions

Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensisDIETARY_SUPPLEMENT

Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis, 1 capsule per day during 14

Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis
PlaceboOTHER

Placebo, 1 capsule per day during 14

Placebo

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child from a study of contact with tuberculosis. Obtaining informed consent from parents / mothers or guardians and, over 12 years, obtaining the consent of the child.
  • Child between 2 and 17 years (inclusive) on the day of obtaining informed consent.
  • Willingness to fulfill the requirements of the protocol.

You may not qualify if:

  • Active tuberculosis. Enrollment in another clinical trial or study with sanitary product involving invasive techniques.
  • Chronic administration of: methotrexate, azathioprine, cyclophosphamide, oral corticosteroids (≥500mg cumulative prednisone dose, or equivalent; inhaled or topical steroids are allowed) and other immunosuppressive therapies / immunomodulatory .
  • Administration of blood products or blood derivatives during the 6 months prior to randomization.
  • Vaccination in the month prior to randomization. Anticipation of receiving vaccines duration of the study.
  • 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.
  • Known immunodeficiencies. Pregnancy or breastfeeding. Hypersensitivity to mannitol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Germans Trias I Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Valle Hebron Hospital

Barcelona, 08035, 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 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

October 19, 2015

First Posted

October 21, 2015

Study Start

December 9, 2015

Primary Completion

March 6, 2019

Study Completion

March 6, 2019

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

ES(3)