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

This study has been completed.
Sponsor:
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02349711
First received: January 23, 2015
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Healthy
Dietary Supplement: Probiotic mixture
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 [ Time Frame: up to 8 weeks from date of randomization ]
    MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)


Secondary Outcome Measures:
  • Serum Total Immunoglobulin E (IgE) [ Time Frame: baseline and week 6 ]
    Serum total immunoglobulin E (IgE) was quantified via ELISA

  • Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire [ Time Frame: weeks 0, 1, 2, 3, 4, 5, 6, 7 ]
    Symptoms included in this score are constipation, hard stools, and feeling of incomplete evacuation reported on a weekly Gastrointestinal Symptom Response Scale (GSRS) questionnaire. Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.

  • Regulatory T Cells (Tregs) [ Time Frame: baseline and week 6 ]
    Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry


Enrollment: 224
Study Start Date: January 2015
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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).
Dietary Supplement: 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.
Experimental: Probiotic mixture
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).
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.
Other Names:
  • Kyo-Dophilus
  • Lactobacillus gasseri KS-13
  • Bifidobacterium bifidum G9-1
  • Bifidobacterium longum MM-2

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02349711

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Wakunaga Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02349711     History of Changes
Other Study ID Numbers: IRB201400894
Project No. 00120905 ( Other Identifier: Wakunaga Pharmaceutical Co., Ltd. )
Study First Received: January 23, 2015
Results First Received: May 24, 2016
Last Updated: July 19, 2016

Keywords provided by University of Florida:
probiotic
allergy
immune

Additional relevant MeSH terms:
Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on March 23, 2017