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COVID-19 related personnel, reagent and budget related impacts
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Normal aging can lead to loss of gut microbial biodiversity which is linked to inflammaging and immunosenescence or the loss of immunocompetence. Probiotics, such as VSL#3®, and certain herbal supplements such as Triphala are associated with restoration of gut community architecture, increased gut barrier function and decreased inflammation. The present project will examine the potential benefits of a synbiotic (which denotes a prebiotic plus probiotic, and in this study, is an herbal prebiotic plus probiotic) intervention (8 weeks of supplementation) on gut microbiome profiles assessed via stool, inflammatory blood markers, and questionnaires about gastrointestinal health and mood. In this exploratory study, the investigators will examine psychological and physical functioning at baseline and after 8 weeks of supplementation with synbiotic, Triphala alone, or placebo.
Primary Aim: In healthy, cognitively intact elderly subjects, determine the effects of an 8-week synbiotic supplement intervention on the stool microbiome (pre- and post-intervention) as compared to Triphala alone and placebo.
Secondary Aim: In healthy elderly subjects, examine the effects of an 8-week synbiotic supplementation intervention on inflammatory blood markers compared to herb alone or placebo.
Exploratory Aim 1: In healthy elderly subjects, examine the effects of an 8-week synbiotic intervention on gastrointestinal and psychological health via questionnaires compared to herb alone or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Experimental | Two grams of organic Triphala powder (Banyan Botanicals, Inc.) with 1 capsule VSL#3® (VSL Pharmaceuticals, Inc.) probiotic taken with a few ounces of room temperature water in the morning and at bedtime for 8 weeks. Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.) and VSL#3® (VSL Pharmaceuticals, Inc.) capsules. |
|
| Probiotic | Active Comparator | Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.). Subjects will take 2 grams of organic Triphala powder with a few ounces of room temperature water in the morning and at bedtime. |
|
| Placebo | Placebo Comparator | Subjects will be provided both written and verbal instructions and given a kit containing placebo capsules. Subjects will be instructed to take 2 (inert) capsules with room temperature water in the morning and at bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic | Dietary Supplement | an herbal prebiotic plus probiotic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Measures of Gut Microbiome Health | 16S rDNA sequencing of stool sample | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Biomarkers | Measure concentrations of 30 cytokines in blood samples with standard ELISA panel | 8 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine T Peterson, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
18 subjects began the intervention (2 dropped out) before the study was closed. Few subjects were able to begin the intervention compared to what was planned before the study was closed due to multiple pandemic related impacts. As the budget was impacted, no data was generated. No data is reported as the samples will not be processed and no data was generated.
Recruitment dates 07/01/2019 - 11/01/2019. The location is UCSD School of Medicine Building 4 via IRB approved phone script. 34 subjects were approved for enrollment for our first wave of intervention/subjects and 18 began the study before the study was closed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synbiotic | Synbiotic Group. Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.) and VSL#3® (VSL Pharmaceuticals, Inc.) capsules. Subjects will take 2 grams of encapsulated organic Triphala powder and 1 capsule of VSL#3 with room temperature water in the morning and at bedtime. Synbiotic: an herbal prebiotic plus probiotic |
| FG001 | Triphala | Triphala Group. Subjects will be provided both written and verbal instructions and given a kit containing Triphala capsules (Banyan Botanicals). Subjects will take 4 capsules (2g) of Triphala with room temperature water in the morning and at bedtime. Triphala: encapsulated |
| FG002 | Placebo | Subjects will be provided both written and verbal instructions and given a kit containing encapsulated placebo powder (made by VSL#3 manufacterer). Subjects will take 2 grams of organic placebo powder with a few ounces of room temperature water in the morning and at bedtime. Placebo: Inert capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As only a few subjects took the intervention before the study was closed due to COVID-19, no data was generated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Synbiotic | Two grams of organic Triphala powder (Banyan Botanicals, Inc.) with 1 capsule VSL#3® (VSL Pharmaceuticals, Inc.) probiotic taken with a few ounces of room temperature water in the morning and at bedtime for 8 weeks. Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.) and VSL#3® (VSL Pharmaceuticals, Inc.) capsules. Synbiotic: an herbal prebiotic plus probiotic |
| 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 | Objective Measures of Gut Microbiome Health | 16S rDNA sequencing of stool sample | Study closed due to COVID-19. No data was generated. No data was analyzed. | Posted | 8 weeks |
|
6 months.
Adverse event collection was obtained by the UCSD study coordinator and clinical attendants.
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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 | Synbiotic | Synbiotic Group. Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.) and VSL#3® (VSL Pharmaceuticals, Inc.) capsules. Subjects will take 2 grams of encapsulated organic Triphala powder and 1 capsule of VSL#3 with room temperature water in the morning and at bedtime. Synbiotic: an herbal prebiotic plus probiotic |
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Study Closed early due to COVID-19 related impacts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Tara Peterson | UCSD School of Medicine | 7033959377 | chpeterson@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2020 | Jun 30, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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Interested and eligible participants will be randomly assigned to either an 8-week synbiotic group, herb alone, or placebo control with a goal to obtain 60 patients who complete the study (20 in each group) after an estimated 20% attrition. Placebo control subjects will be given the option of having the 8-weeks of herbal synbiotic for directed personal use upon conclusion of the study.
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This study will employ double-blind masking and only the project manager will be aware if the participant is assigned to take the synbiotic, triphala alone, or placebo. At the end of the 8 weeks, participants will be made aware of their randomly assigned supplement.
| Probiotic |
| Dietary Supplement |
Triphala alone |
|
| Placebo | Dietary Supplement | Inert capsule |
|
| BG001 | Triphala | Triphala Group. Subjects will be provided both written and verbal instructions and given a kit containing Triphala capsules (Banyan Botanicals). Subjects will take 4 capsules (2g) of Triphala with room temperature water in the morning and at bedtime. Triphala: encapsulated |
| BG002 | Placebo | Subjects will be provided both written and verbal instructions and given a kit containing placebo capsules. Subjects will be instructed to take 2 (inert) capsules with room temperature water in the morning and at bedtime. Placebo: Inert capsule |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.). Subjects will take 2 grams of organic Triphala powder with a few ounces of room temperature water in the morning and at bedtime.
Probiotic: Triphala alone
| OG002 | Placebo | Subjects will be provided both written and verbal instructions and given a kit containing placebo capsules. Subjects will be instructed to take 2 (inert) capsules with room temperature water in the morning and at bedtime. Placebo: Inert capsule |
|
| Secondary | Inflammatory Biomarkers | Measure concentrations of 30 cytokines in blood samples with standard ELISA panel | No data was generated or analyzed. Study closed due to COVID-19 impacts. | Posted | 8 weeks |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Probiotic | Probiotic Group. Subjects will be provided both written and verbal instructions and given a kit containing VSL#3® (VSL Pharmaceuticals, Inc.) capsules. Subjects will take 1 capsule of VSL#3 with room temperature water in the morning and at bedtime. Probiotic: capsule | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Placebo | Subjects will be provided both written and verbal instructions and given a kit containing encapsulated placebo powder (made by VSL#3 manufacterer). Subjects will take 2 grams of organic placebo powder with a few ounces of room temperature water in the morning and at bedtime. Placebo: Inert capsule | 0 | 5 | 0 | 5 | 0 | 5 |
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| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|