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Other Dietary Supplements

Sulfalene

Acidophilus

Bifidobacterium

Daily consumption of pills containing prebiotics and probiotics

Daily consumption of pills containing maltodextrin

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)

probiotic plus prebiotic supplement

Daily consumption of visually similar placebo pills

placebo

Andrew D Frugé, PhD

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.

Placebo controlled randomized controlled trial

One study staff member will be responsible for randomization and allocation of intervention supplement or placebo, which will be appear to be identical

Anti-anxiety Biotics for Breast Cancer Survivors

Synbiotic Supplementation to Reduce Anxiety Symptoms in Female Breast Cancer Survivors and/or Their Female Relatives

Number of Participants who were accrued in 6 months

Retain 85% of randomized participants for duration of study (6 weeks)

80% of participants consuming pills on 90% of intervention days

Decrease in Generalized Anxiety Disorder-7 (GAD-7) score, which ranges from 0 (no anxiety) to 21 (severe anxiety).

Pro-inflammatory cytokine, Interleukin-6 (serum)

16s changes in microbiota alpha diversity

National Center for Advancing Translational Sciences (NCATS)

Auburn University

Assistant Professor

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)

Synbiotic Supplement Group

Daily consumption of pills containing maltodextrin

placebo: Daily consumption of visually similar placebo pills

Placebo Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

7 items, 0-3 score for each response; 21 points possible - Range 0-21. No subscales. Higher score is a less desirable outcome.

Generalized Anxiety Disorder Screener (GAD-7) Score

Biospecimen samples will never be analyzed. Data not collected for secondary outcome measures.

Drew Frugé

Feasibility - Accrual

Feasibility - Retention

Feasibility - Adherence

Outcome cannot be reported. Identification of age and race in baseline characteristics with total sample of n=3 compromises personally identifiable information.

Spots Global Cancer Trial Database for probiotic plus prebiotic supplement