NCT01779895

Brief Summary

The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

January 22, 2013

Last Update Submit

April 8, 2014

Conditions

Rhinitis, Allergic, Perennial

Keywords

Dust mitePerennial allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)

    Compared over 8 weeks between the two treatment groups

    8 weeks

Secondary Outcomes (5)

  • Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells

    Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks

  • Basophil activation in ex-vivo stimulated whole blood cells

    Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks

  • Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score

    Measured weekly for the 8 weeks of product intake

  • Level of Specific Immunoglobulin E

    Measured 2 times: at the start of product intake and after 8 weeks

  • Frequency of adverse events

    during the 8 weeks of product intake

Study Arms (2)

NCC2461

ACTIVE COMPARATOR

probiotic blended in maltodextrin powder to be taken daily

Dietary Supplement: Lactobacillus paracasei probiotic strain

Placebo

PLACEBO COMPARATOR

maltodextrin

Dietary Supplement: Placebo

Interventions

Lactobacillus paracasei probiotic strainDIETARY_SUPPLEMENT
NCC2461
PlaceboDIETARY_SUPPLEMENT

maltodextrin

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between 20-65 years old
  • Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1
  • Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract
  • Body Mass Index 19-29
  • Having obtained his/her informed consent

You may not qualify if:

  • Anemia
  • Allergy to any food or medication
  • Asthma
  • Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments
  • Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening
  • Consumption of probiotic and other dietary nutritional interventions
  • More than 2 drinks/day alcohol consumption or use of illicit drugs
  • Pregnant women
  • Subjects with expected low compliance
  • Blood donation in the past month or planning to donate blood until a month after the end of the study
  • Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metabolic Unit, Nestlé Research Centre

Lausanne, 1000, Switzerland

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Maurice Beaumont, MD

    Nestlé Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 30, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2013

Study Completion

September 1, 2013

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

CH(1)