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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR003096-03 | U.S. NIH Grant/Contract | View source |
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Only three participants enrolled
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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Cancer survivors experience more rapid declines in health-related quality of life which include physical and psychological comorbidities, the latter of which may be subclinical and often overlooked by primary care providers. Recently, the gut-brain axis (GBA) has been identified as a therapeutic target to improve host health. The GBA is greatly influenced by the composition of the gut microbiome, as microbial metabolites directly influence the central nervous system. Thus, prebiotics, probiotics, and synbiotics (a combination of pre- and probiotics) have emerged as a possible approach to treating anxiety symptoms. Preclinical studies suggest efficacy of synbiotics, while pre- and probiotics have only been studied in isolation in humans.
This is a double-blind, placebo-controlled clinical trial in which female breast cancer survivors and/or their female relatives experiencing moderate to severe anxiety symptoms will be randomized to daily consumption of the synbiotic supplement or placebo. The previously validated Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptom severity at study screening and at each time point. The primary outcome of this study is feasibility, measured by accrual, adherence, retention, and adverse effects. Secondary outcomes relate to reduction of anxiety symptoms and other physiological changes. No study has investigated the mediating effects of gut microbiota and inflammatory markers on the ability of synbiotics to reduce anxiety symptoms. Thus, at each timepoint, phlebotomy will be conducted to determine serum levels of inflammatory cytokines and stool samples will be collected to determine alpha- and beta-diversity of the fecal microbiome as well as relative abundance of target genera. Hypothesis: this placebo-controlled study will be feasible and synbiotic treatment will result in a significant reduction in anxiety symptoms and inflammatory markers, which may be moderated by changes in the microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic supplement group | Experimental | Daily consumption of pills containing prebiotics and probiotics |
|
| Placebo group | Placebo Comparator | Daily consumption of pills containing maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic plus prebiotic supplement | Dietary Supplement | Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Accrual | Number of Participants who were accrued in 6 months | 6 months |
| Feasibility - Retention | Retain 85% of randomized participants for duration of study (6 weeks) | 6 weeks |
| Feasibility - Adherence | 80% of participants consuming pills on 90% of intervention days | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Symptoms | Decrease in Generalized Anxiety Disorder-7 (GAD-7) score, which ranges from 0 (no anxiety) to 21 (severe anxiety). | 4 weeks |
| Serotonin | Serum 5-hydroxytryptamine |
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Inclusion Criteria:
Female breast cancer survivors or female relatives of a breast cancer survivor who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Frugé, PhD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University | Auburn | Alabama | 36849 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31858898 | Background | Smith KS, Greene MW, Babu JR, Fruge AD. Psychobiotics as treatment for anxiety, depression, and related symptoms: a systematic review. Nutr Neurosci. 2021 Dec;24(12):963-977. doi: 10.1080/1028415X.2019.1701220. Epub 2019 Dec 20. |
| Label | URL |
|---|---|
| Study website | View source |
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No pre-assignment activities. Participants were randomized and received intervention or treatment immediately after baseline data collection was completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synbiotic Supplement Group | Daily consumption of pills containing prebiotics and probiotics probiotic plus prebiotic supplement: Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS) |
| FG001 | Placebo Group | Daily consumption of pills containing maltodextrin placebo: Daily consumption of visually similar placebo pills |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Synbiotic Supplement Group | Daily consumption of pills containing prebiotics and probiotics probiotic plus prebiotic supplement: Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS) |
| 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 | Feasibility - Accrual | Number of Participants who were accrued in 6 months | Number of Participants who were accrued in 6 months | Posted | Count of Participants | Participants | 6 months |
|
6 weeks
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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 Supplement Group | Daily consumption of pills containing prebiotics and probiotics probiotic plus prebiotic supplement: Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS) |
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Biospecimen samples will never be analyzed. Data not collected for secondary outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drew Frugé | Auburn University | 3348448433 | adf0003@auburn.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 | Feb 24, 2021 | Aug 1, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2022 | Aug 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Placebo controlled randomized controlled trial
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One study staff member will be responsible for randomization and allocation of intervention supplement or placebo, which will be appear to be identical
| placebo | Dietary Supplement | Daily consumption of visually similar placebo pills |
|
| 4 weeks |
| Inflammatory Marker - TNF-alpha | Serum Tumor Necrosis Factor-alpha | 4 weeks |
| Inflammatory Marker - LBP | Serum Lipopolysaccharide Binding Protein | 4 weeks |
| Inflammatory Marker - IL-6 | Pro-inflammatory cytokine, Interleukin-6 (serum) | 4 weeks |
| Fecal Microbiome Composition | 16s changes in microbiota alpha diversity | 4 weeks |
| BG001 |
| Placebo Group |
Daily consumption of pills containing maltodextrin placebo: Daily consumption of visually similar placebo pills |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Generalized Anxiety Disorder Screener (GAD-7) Score | 7 items, 0-3 score for each response; 21 points possible - Range 0-21. No subscales. Higher score is a less desirable outcome. | Mean | Standard Deviation | units on a scale (min=0; max=21) |
|
|
|
| Primary | Feasibility - Retention | Retain 85% of randomized participants for duration of study (6 weeks) | All participants analyzed | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Primary | Feasibility - Adherence | 80% of participants consuming pills on 90% of intervention days | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Anxiety Symptoms | Decrease in Generalized Anxiety Disorder-7 (GAD-7) score, which ranges from 0 (no anxiety) to 21 (severe anxiety). | Outcome cannot be reported. Identification of age and race in baseline characteristics with total sample of n=3 compromises personally identifiable information. | Posted | 4 weeks |
|
|
| Secondary | Serotonin | Serum 5-hydroxytryptamine | Biospecimen samples will never be analyzed. Data not collected. | Posted | 4 weeks |
|
|
| Secondary | Inflammatory Marker - TNF-alpha | Serum Tumor Necrosis Factor-alpha | Biospecimen samples will never be analyzed. Data not collected. | Posted | 4 weeks |
|
|
| Secondary | Inflammatory Marker - LBP | Serum Lipopolysaccharide Binding Protein | Biospecimen samples will never be analyzed. Data not collected. | Posted | 4 weeks |
|
|
| Secondary | Inflammatory Marker - IL-6 | Pro-inflammatory cytokine, Interleukin-6 (serum) | Biospecimen samples will never be analyzed. Data not collected. | Posted | 4 weeks |
|
|
| Secondary | Fecal Microbiome Composition | 16s changes in microbiota alpha diversity | Biospecimen samples will never be analyzed. Data not collected. | Posted | 4 weeks |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo Group | Daily consumption of pills containing maltodextrin placebo: Daily consumption of visually similar placebo pills | 0 | 2 | 0 | 2 | 0 | 2 |
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| D019602 |
| Food and Beverages |