N/A
N=173
Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02349711 ↗Enrolled (actual)
173
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ — -0.1946; -0.6772 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Probiotic mixture (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ |
-0.1946; -0.6772 | — |
| SECONDARY Serum Total Immunoglobulin E (IgE) |
325.3243243; 781.0285714; 352.6111111; 843.3428571 | — |
| SECONDARY Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire |
1.57; 1.51; 1.51; 1.49; 1.59; 1.53 | — |
| SECONDARY Regulatory T Cells (Tregs) |
4.1931; 4.4146; 4.7733; 4.8626 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02349711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.