Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/8/2015 |
| Start Date: | January 2015 |
| End Date: | May 2015 |
| Contact: | Bobbi Langkamp-Henken, PhD, RD |
| Email: | henken@ufl.edu |
| Phone: | 352-392-1991 |
Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) and Health-related Quality of Life in Individuals With Seasonal Allergies
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.
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.
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.
We found this trial at
1
site
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials
