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

University of Florida

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Probiotic mixture; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02349711

Project No. 00120905 (Other Identifier)

IRB201400894

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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224 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Placebo

Probiotic mixture

Experimental group

Description:

A commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).

Treatment:

Dietary Supplement: Probiotic mixture