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Completed

NCT Number: NCT02349711

Probiotics 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.

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Key information

Conditions

Healthy Hypersensitivity Immune System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic mixture

Dietary Supplement

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

Placebo

Dietary Supplement

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.

Primary outcomes

  1. 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 outcomes

  1. Serum Total Immunoglobulin E (IgE)

    Time frame: baseline and week 6

    Serum total immunoglobulin E (IgE) was quantified via ELISA

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Wakunaga Pharmaceutical Co., Ltd.

Registry information

Official study 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

Acronym: JEN

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2015
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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