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| Name | Class |
|---|---|
| Lallemand Human Nutrition | UNKNOWN |
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The purpose of this study is to evaluate the effect of three doses of the probiotic B. subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general wellness in healthy young adults, survival through the gastrointestinal tract and impact on intestinal microbes.
A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to 50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day) for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit survival, daily questionnaires (DQ) will be administered to assess general wellness, and gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal Symptom Response Scale (GSRS) questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks. |
|
| B. subtilis R0179 (10 billion CFU) | Experimental | B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. * CFU (Colony Forming Unit) |
|
| B. subtilis R0179 (1 billion CFU) | Experimental | B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks. |
|
| B. subtilis R0179 (0.1 billion CFU) | Experimental | B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. subtilis R0179 | Dietary Supplement | B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g). | 6 weeks |
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Inclusion Criteria: Participants
Exclusion Criteria: Potential Participants will be excluded if they
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| Name | Affiliation | Role |
|---|---|---|
| Wendy J Dahl, PhD, RD | University of Florida | Principal Investigator |
| Bobbi Henken-Langkamp, PhD, RD | University of Florida | Principal Investigator |
| Volker Mai, PhD | 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 |
|---|---|---|---|
| 16102604 | Background | Hong HA, Duc le H, Cutting SM. The use of bacterial spore formers as probiotics. FEMS Microbiol Rev. 2005 Sep;29(4):813-35. doi: 10.1016/j.femsre.2004.12.001. Epub 2004 Dec 16. | |
| 19783474 | Background | Oelschlaeger TA. Mechanisms of probiotic actions - A review. Int J Med Microbiol. 2010 Jan;300(1):57-62. doi: 10.1016/j.ijmm.2009.08.005. Epub 2009 Sep 23. |
| Label | URL |
|---|---|
| Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults. | View source |
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A one week baseline period was to be completed before participants were randomized to intervention arms. Participants that failed to complete study requirements during this period were withdrawn due to noncompliance.
Healthy adults were recruited by flyers and word of mouth on the University of Florida campus. Rolling recruitment (7/02/2012-08/23/2012) occurred until the minimum number of participants (n=80) had been enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks. Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day. |
| FG001 | B. Subtilis R0179 (0.1 Billion CFU) | B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
| FG002 | B. Subtilis R0179 (1 Billion CFU) | B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
| FG003 | B. Subtilis R0179 (10 Billion CFU) | B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed all study requirements were included in the baseline analysis population. 2 participants in the 1 Billion CFU group were excluded from the baseline analysis because they did not complete all study requirements.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks. Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day. |
| BG001 | B. Subtilis R0179 (0.1 Billion CFU) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
|
Data monitoring adverse events was collected over the study period.
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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 (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks. Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Blood and lymphatic system disorders | Systematic Assessment | One participant reported a serious adverse event of hospitalization with an admitting diagnosis of hypotension, but did not discontinue probiotic consumption and completed the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrheal Symptoms | Gastrointestinal disorders | Non-systematic Assessment | One participant in the 0.1 billion CFU treatment group experienced diarrheal symptoms and completed the study, this event did not occur in any other participants and did not persist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wendy Dahl | Department of Food Science and Human Nutrition, University of Florida | 352-392-1991 | 224 | wdahl@ufl.edu |
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| Placebo | Dietary Supplement | Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day. |
|
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire. | Weekly for 6 weeks |
| Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort). | Weeks 1, 5, and 6 |
| 33451235 | Background | Sanders ME, Morelli L, Tompkins TA. Sporeformers as Human Probiotics: Bacillus, Sporolactobacillus, and Brevibacillus. Compr Rev Food Sci Food Saf. 2003 Jul;2(3):101-110. doi: 10.1111/j.1541-4337.2003.tb00017.x. |
| 18449224 | Background | Tompkins TA, Hagen KE, Wallace TD, Fillion-Forte V. Safety evaluation of two bacterial strains used in Asian probiotic products. Can J Microbiol. 2008 May;54(5):391-400. doi: 10.1139/w08-022. |
| 21840798 | Background | Tompkins TA, Xu X, Ahmarani J. A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation. Benef Microbes. 2010 Mar;1(1):93-106. doi: 10.3920/BM2008.1005. |
| 25062611 | Derived | Hanifi A, Culpepper T, Mai V, Anand A, Ford AL, Ukhanova M, Christman M, Tompkins TA, Dahl WJ. Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults. Benef Microbes. 2015 Mar;6(1):19-27. doi: 10.3920/BM2014.0031. |
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
| BG002 | B. Subtilis R0179 (1 Billion CFU) | B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
| BG003 | B. Subtilis R0179 (10 Billion CFU) | B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| BMI Percentiles | Number | participants |
|
| Activity Level | Minutes of physical activity were assessed according the Global Physical Activity Questionnaire | Mean | Standard Deviation | mins of moderate and intense activity |
|
| OG001 |
| B. Subtilis R0179 (0.1 Billion CFU) |
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
| OG002 | B. Subtilis R0179 (1 Billion CFU) | B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
| OG003 | B. Subtilis R0179 (10 Billion CFU) | B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. |
|
|
| Secondary | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | log CFU/g | 6 weeks |
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
|
|
|
| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
|
|
|
| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
|
|
|
| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
|
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
|
|
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weekly for 6 weeks |
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire. | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | Hours | Weekly for 6 weeks |
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| Primary | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort). | Participants who completed all study requirements were included in the baseline analysis population. | Posted | Mean | Standard Error | units on a scale | Weeks 1, 5, and 6 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | B. Subtilis R0179 (0.1 Billion CFU) | B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. | 1 | 21 | 1 | 21 |
| EG002 | B. Subtilis R0179 (1 Billion CFU) | B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. | 0 | 22 | 0 | 22 |
| EG003 | B. Subtilis R0179 (10 Billion CFU) | B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. | 0 | 20 | 1 | 20 |
|
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| Itchiness and Redness Symptoms | Skin and subcutaneous tissue disorders | Non-systematic Assessment | A participant in the 10 billion CFU treatment group experienced itchiness/redness symptoms that were sporadic and persisted for several days. The participant voluntarily withdrew from the study, these symptoms did not occur in any other participants. |
|
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| GI Viability of Bacillus Spores Week 5 |
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| GI Viability of Bacillus Spores Week 6 |
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| Daily Questionnaire (Cephalic) Week 2 |
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| Daily Questionnaire (Cephalic) Week 3 |
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| Daily Questionnaire (Cephalic) Week 4 |
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| Daily Questionnaire (Cephalic) Week 5 |
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| Daily Questionnaire (Cephalic) Week 6 |
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| Daily Questionnaire (Epidermal) Week 2 |
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| Daily Questionnaire (Epidermal) Week 3 |
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| Daily Questionnaire (Epidermal) Week 4 |
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| Daily Questionnaire (Epidermal) Week 5 |
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| Daily Questionnaire (Epidermal) Week 6 |
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| Daily Questionnaire (ENT) Week 2 |
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| Daily Questionnaire (ENT) Week 3 |
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| Daily Questionnaire (ENT) Week 4 |
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| Daily Questionnaire (ENT) Week 5 |
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| Daily Questionnaire (ENT) Week 6 |
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| Daily Questionnaire (Behavioral) Week 2 |
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| Daily Questionnaire (Behavioral) Week 3 |
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| Daily Questionnaire (Behavioral) Week 4 |
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| Daily Questionnaire (Behavioral) Week 5 |
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| Daily Questionnaire (Behavioral) Week 6 |
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| Daily Questionnaire (Emetic) Week 2 |
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| Daily Questionnaire (Emetic) Week 3 |
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| Daily Questionnaire (Emetic) Week 4 |
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| Daily Questionnaire (Emetic) Week 5 |
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| Daily Questionnaire (Emetic) Week 6 |
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| Daily Questionnaire (Constipation) Week 2 |
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| Daily Questionnaire (Constipation) Week 3 |
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| Daily Questionnaire (Constipation) Week 4 |
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| Daily Questionnaire (Constipation) Week 5 |
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| Daily Questionnaire (Constipation) Week 6 |
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| Daily Questionnaire (Diarrhea) Week 2 |
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| Daily Questionnaire (Diarrhea) Week 3 |
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| Daily Questionnaire (Diarrhea) Week 4 |
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| Daily Questionnaire (Diarrhea) Week 5 |
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| Daily Questionnaire (Diarrhea) Week 6 |
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| Daily Questionnaire (Fatigue) Week 2 |
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| Daily Questionnaire (Fatigue) Week 3 |
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| Daily Questionnaire (Fatigue) Week 4 |
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| Daily Questionnaire (Fatigue) Week 5 |
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| Daily Questionnaire (Fatigue) Week 6 |
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| Daily Questionnaire (Satiety) Week 2 |
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| Daily Questionnaire (Satiety) Week 3 |
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| Daily Questionnaire (Satiety) Week 4 |
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| Daily Questionnaire (Satiety) Week 5 |
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| Daily Questionnaire (Satiety) Week 6 |
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| Daily Questionnaire (Bowel Mov.) Weeks 2-5 |
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| Daily Questionnaire (Bowel Mov.) Week 6 |
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| Daily Questionnaire (Hours of Sleep) Week 2 |
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| Daily Questionnaire (Hours of Sleep) Week 3 |
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| Daily Questionnaire (Hours of Sleep) Week 4 |
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| Daily Questionnaire (Hours of Sleep) Week 5 |
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| Daily Questionnaire (Hours of Sleep) Week 6 |
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| GSRS (Abdominal Pain) Week 5 |
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| GSRS (Abdominal Pain) Week 6 |
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| GSRS (Reflux) Week 1 |
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| GSRS (Reflux) Week 5 |
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| GSRS (Reflux) Week 6 |
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| GSRS (Indigestion) Week 1 |
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| GSRS (Indigestion) Week 5 |
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| GSRS (Indigestion) Week 6 |
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| GSRS (Constipation) Week 1 |
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| GSRS (Constipation) Week 5 |
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| GSRS (Constipation) Week 6 |
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| GSRS (Diarrhea) Week 1 |
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| GSRS (Diarrhea) Week 5 |
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| GSRS (Diarrhea) Week 6 |
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