NCT04058340

Brief Summary

The project is intended to be realised in two phases. In the first stage, a case control study will be performed. In the second phase, double-blind, placebo controlled cross-over study will be conducted. The first stage it to compare innate immunity activation and Pseudomonas aeruginosa (Pa) expression between Pa positive and negative patients. In the second phase the effects of inhaled lactizole- TAS3R inhibitor will be assessed.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

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

Study Start

First participant enrolled

July 30, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

August 12, 2019

Last Update Submit

August 16, 2019

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Pseudomonas aeruginosa abundance

    Decrease of abundance of P. aeruginosa in throat swabs after nebulized lactizole . intervention. PCR testing for the presence of Pseudomonas aeruginosa genetic material (FTD Bacterial pneumoniae-HAP, Fast-track diagnostics Ltd., Malta)

    Change from Baseline after 4 weeks of the intervention

Secondary Outcomes (5)

  • Change from Baseline in cystic fibrosis symptoms

    Change from Baseline after 4 weeks of the intervention

  • Change from Baseline in Lung function test

    Change from Baseline after 4 weeks of the intervention

  • Change from Baseline in Taste perception

    Change from Baseline after 4 weeks of the intervention

  • Change from Baseline in Nasal ILC1, 2 and 3 cells

    Change from Baseline after 4 weeks of the intervention

  • Change from Baseline in Nasal cytokines expression

    Change from Baseline after 4 weeks of the intervention

Study Arms (2)

lactizole-placebo

ACTIVE COMPARATOR

A group of patients who will receive 3ml lactizole solution (150ppm) in nebulization twice a day for 4 weeks , and then for the next 4 weeks they will receive 2 times a day 3ml 0.9% NaCl solution in nebulization

Dietary Supplement: lactizole nebulizationOther: Placebo

placebo-lactizole

ACTIVE COMPARATOR

A group of patients who will receive 2 times a day for 4 weeks (0.9% NaCl solution in nebulization) for 4 weeks and will receive 3ml of lactizole solution (150ppm) in nebulization 2 times a day for 4 weeks

Dietary Supplement: lactizole nebulizationOther: Placebo

Interventions

lactizole nebulizationDIETARY_SUPPLEMENT

Lactizole is generally recognized as safe: GRAS Flavor and Extract Manufacturers Association ( numer: 3773 ) Lactizole solution for nebulization was calculated based on dose-response curves; 150ppm was chosen as minimal effective (decreased sweet taste perception) and safety ( lack of FEV1 changes after nebulization)

lactizole-placeboplacebo-lactizole
PlaceboOTHER

0.9% NaCl solution in nebulization

lactizole-placeboplacebo-lactizole

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ulmonary manifestations of cystic fibrosis

You may not qualify if:

  • first positive result of inoculation from the airways, which according to the standard is associated with the need for antibiotic therapy
  • contraindication to a biopsy of the nasal mucosa
  • exacerbation requiring antibiotics
  • diabetes, exposure to tobacco smoke
  • other chronic diseases and clinical conditions which, according to the researcher, may influence the assessed parameters and the course of the study.
  • \- acute respiratory infection within 2 weeks from 1, 2 and 3 visits of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland

Lodz, 90-153, Poland

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Central Study Contacts

Paweł Majak

CONTACT

600621878pmajak@o2.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 15, 2019

Study Start

July 30, 2019

Primary Completion

November 30, 2019

Study Completion

December 30, 2019

Last Updated

August 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)