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Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens

NCT01096615 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2012-07-26

No results posted yet for this study

Summary

The aim of the study is to show an improvement of quality of life on the 5th week of product consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in subjects with persistent allergic rhinitis currently treated with Loratadine or oral anti-histaminic treatment.

Conditions

  • Rhinitis

Interventions

DIETARY_SUPPLEMENT

Placebo

Description: \- capsule size 3 Composition of the product: * 45 mg of microcristalline cellulose, * 132 mg of maltodextrin, * 3 mg of magnesium stearate. Composition of the capsule: * 46 mg of hypromellose, * 1 mg of titanium dioxide. Packaging: Products are packaged in aluminium tubes of 30 capsules. Storage: The product should be stored in a fridge. Direction for use: subject should consume 1 capsule daily together with a meal, with a glass of water. The study products will be consumed daily for 7 weeks.

DIETARY_SUPPLEMENT

Lactobacillus paracasei LP-33

Description: * minimum 2.0x109 CFU of Lactobacillus paracasei LP-33 * capsule size 3 1 capsule daily together with a meal, with a glass of water.

Sponsors & Collaborators

  • Chr Hansen

    collaborator INDUSTRY

  • Merck Medication Familiale

    lead INDUSTRY

Principal Investigators

  • Jean BOUSQUET, Pr

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096615 on ClinicalTrials.gov