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| ID | Type | Description | Link |
|---|---|---|---|
| Project No. 00120905 | Other Identifier | Wakunaga Pharmaceutical Co., Ltd. |
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| Name | Class |
|---|---|
| Wakunaga Pharmaceutical Co., Ltd. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Total Immunoglobulin E (IgE) | Serum total immunoglobulin E (IgE) was quantified via ELISA | baseline and week 6 |
| Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire |
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Inclusion Criteria:
Subjects will be included if they:
Exclusion Criteria:
Subjects will be excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28228426 | Derived | 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. |
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Before randomization, participants provided anthropometric measurements and demographic information. Out of the 224 participants who consented to participate, only 173 remained at randomization due to the participants no longer being interested or not coming to their study visits to be randomized.
Participants were recruited from the Gainesville, FL area, including the University of Florida campus. Recruiting began in January of 2015 and took place in facilities within the Food Science and Human Nutrition Department at the University of Florida. Participants were enrolled from 1-20-15 to 3-12-15.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch. |
| FG001 | Probiotic Mixture | A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch. |
| BG001 | Probiotic Mixture |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains) | Because this was an intent-to-treat study, all data from all randomized participants was considered for analysis. No imputation was done, so missing values excluded a participant from the analysis. While data from a participant may be missing, they were considered to have "completed" the study if they completed all study visits. | Posted | Least Squares Mean | Standard Error | units on a scale | up to 8 weeks from date of randomization |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bobbi Langkamp-Henken | Food Science and Human Nutrition Department, University of Florida | 352-294-3721 | henken@ufl.edu |
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| ID | Term |
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| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| 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. |
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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.
| weeks 0, 1, 2, 3, 4, 5, 6, 7 |
| Regulatory T Cells (Tregs) | Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry | baseline and week 6 |
A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Probiotic Mixture | A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica. |
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| Secondary | Serum Total Immunoglobulin E (IgE) | Serum total immunoglobulin E (IgE) was quantified via ELISA | A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples. | Posted | Mean | Standard Error | ng/mL | baseline and week 6 |
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| Secondary | Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire | 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. | Since this outcome had more than two time points, and since all randomized participants provided some weeks of survey data, all participants were included in the analysis (even those that were lost to follow up). The number of values (and thus the number analyzed) by week is also shown. | Posted | Mean | Standard Error | units on a scale | weeks 0, 1, 2, 3, 4, 5, 6, 7 |
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| Secondary | Regulatory T Cells (Tregs) | Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry | A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples. Some samples could not be accurately measured for this outcome, so those samples were excluded from analysis. | Posted | Least Squares Mean | Standard Error | percentage of CD4+ T lymphocytes | baseline and week 6 |
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| 0 |
| 87 |
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| 87 |
| EG001 | Probiotic Mixture | A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica. | 0 | 86 | 0 | 86 |
The PI shall provide the sponsor copies of any proposed publication or presentation at least 30 days in advance of submission to a journal, editor, or other third party to allow sponsor to determine whether patentable subject matter or sponsor's confidential information would be disclosed.
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