NCT02349711

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 31, 2016

Completed
Last Updated

June 9, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

January 23, 2015

Results QC Date

May 24, 2016

Last Update Submit

May 9, 2017

Conditions

Healthy

Keywords

probioticallergyimmune

Outcome Measures

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

    MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)

    up to 8 weeks from date of randomization

Secondary Outcomes (3)

  • Serum Total Immunoglobulin E (IgE)

    baseline and week 6

  • Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire

    weeks 0, 1, 2, 3, 4, 5, 6, 7

  • Regulatory T Cells (Tregs)

    baseline and week 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Probiotic mixture

EXPERIMENTAL

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

Interventions

Probiotic mixtureDIETARY_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.

Also known as: Kyo-Dophilus, Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2
Probiotic mixture
PlaceboDIETARY_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.

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Dennis-Wall JC, Culpepper T, Nieves C Jr, Rowe CC, Burns AM, Rusch CT, Federico A, Ukhanova M, Waugh S, Mai V, Christman MC, Langkamp-Henken B. Probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and Bifidobacterium longum MM-2) improve rhinoconjunctivitis-specific quality of life in individuals with seasonal allergies: a double-blind, placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Mar;105(3):758-767. doi: 10.3945/ajcn.116.140012. Epub 2017 Feb 22.

    PMID: 28228426DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

Title
Dr. Bobbi Langkamp-Henken
Organization
Food Science and Human Nutrition Department, University of Florida
henken@ufl.edu
352-294-3721

Study Officials

  • Bobbi Langkamp-Henken, PhD, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2015

First Posted

January 29, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 9, 2017

Results First Posted

August 31, 2016

Record last verified: 2017-05

Locations

US(1)