Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies

Healthy Clinical Trial

— JEN  

Official title:

Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) and Health-related Quality of Life in Individuals With Seasonal Allergies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349711
• Other study ID #: IRB201400894
• Secondary ID: Project No. 0012
• Status: Completed
• Phase: N/A
• First received: January 23, 2015
• Last updated: May 11, 2015
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this randomized, double-blind, placebo-controlled study, participants with seasonal allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess health-related quality of life, stress, physical activity, gastrointestinal symptoms, adverse events, and compliance. In a subset of subjects, stool and blood samples will be collected at baseline and at week 6 of the intervention (estimated to be peak allergy season) to characterize microbial communities and immune function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Subjects will be included if they:

• are 18 to 60 years of age (inclusive).

• receive a score of 2 or greater on the Mini Rhinoconjunctivitis Quality of Life Questionnaire.

• are willing and able to complete the Informed Consent Form in English.

• are available for 8 consecutive weeks to participate in this study.

• be willing and able to complete online daily and weekly questionnaires regarding general wellness, bowel function, quality of life, gastrointestinal symptoms, and physical activity.

• are willing and able to maintain their regular level of physical activity and diet for the 8-week study.

• are able to take the study supplement without the aid of another person.

• are willing to discontinue consumption of fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements), or immune-enhancing supplements (e.g., Echinacea or fish oil).

• are willing to provide 2 blood and 2 stool samples (subgroup only).

Exclusion Criteria:

Subjects will be excluded if they:

• do not meet any of the above criteria.

• use allergy medications, including nasal sprays, 5 or more days per week.

• receive allergy shots.

• are currently pregnant or attempting to get pregnant.

• are currently taking any systemic corticosteroids, androgens (such as testosterone), or large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.

• are currently being treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer, etc.); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, or colostomy, but not including GERD; or have a central venous catheter.

• have received chemotherapy or other immune suppressing therapy within the last year.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Rhinitis, Allergic, Seasonal

Intervention

Dietary Supplement:
• Probiotic mixture
A 350 mg capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica.
• Placebo
Placebo will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Supplement contains 348.25 mg of potato starch.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Wakunaga Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastrointestinal symptoms, measured by Gastrointestinal Symptom Response Scale (GSRS) questionnaire	Symptoms such as gas, bloating, and diarrhea will be reported on a weekly Gastrointestinal Symptom Response Scale (GSRS) questionnaire	weeks 1, 2, 3, 4, 5, 6, 7, 8	No
Other	Allergy medication use - measured daily	Amount and types of medication used in addition to the probiotic or placebo in order to combat allergy symptoms	days 1 through 56	No
Other	Physical activity, measured by International Physical Activity Questionnaire (IPAQ)	Physical activity will be assessed with a weekly International Physical Activity Questionnaire (IPAQ)	weeks 1, 2, 3, 4, 5, 6, 7, 8	No
Primary	Health-related quality of life score at the peak week of allergy season for probiotic versus placebo, as measured by MiniRQLQ	MiniRQLQ, global score (an average of the 14 questions; includes all domains)	up to 8 weeks from date of randomization	No
Secondary	Weekly average of daily levels of stress	Daily stress (0 = no stress to 10 = severe or extreme stress)	weeks 1, 2, 3, 4, 5, 6, 7, 8	No
Secondary	Microbiota studies, measured by 16S rRNA sequence analysis and qPCR	Microbial diversity measured by 16S rRNA sequence analysis and qPCR to quantify changes in bacteria of interest	baseline and 6 weeks	No
Secondary	Immune function, measured by T cell subtypes and serum cytokines and immunoglobulin E	T cell subtypes and serum cytokines and immunoglobulin E	baseline and 6 weeks	No