An interventional study of probiotic plus prebiotic supplement and placebo in Anxiety Generalized and Breast Cancer Female, sponsored by Auburn University. Terminated at 1 site in United States. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Auburn University · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 3 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Auburn University is the lead sponsor of 72 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female breast cancer survivors or female relatives of a breast cancer survivor who:
Exclusion Criteria:
Daily consumption of pills containing prebiotics and probiotics
Dietary Supplement: probiotic plus prebiotic supplement
Daily consumption of pills containing maltodextrin
Dietary Supplement: placebo
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)
Daily consumption of visually similar placebo pills
Feasibility - Accrual
Number of Participants who were accrued in 6 months
Time frame: 6 months
Feasibility - Retention
Retain 85% of randomized participants for duration of study (6 weeks)
Time frame: 6 weeks
Feasibility - Adherence
80% of participants consuming pills on 90% of intervention days
Time frame: 4 weeks
Anxiety Symptoms
Decrease in Generalized Anxiety Disorder-7 (GAD-7) score, which ranges from 0 (no anxiety) to 21 (severe anxiety).
Time frame: 4 weeks
Serotonin
Serum 5-hydroxytryptamine
Time frame: 4 weeks
Inflammatory Marker - TNF-alpha
Serum Tumor Necrosis Factor-alpha
Time frame: 4 weeks
Inflammatory Marker - LBP
Serum Lipopolysaccharide Binding Protein
Time frame: 4 weeks
Inflammatory Marker - IL-6
Pro-inflammatory cytokine, Interleukin-6 (serum)
Time frame: 4 weeks
Fecal Microbiome Composition
16s changes in microbiota alpha diversity
Time frame: 4 weeks
| Milestone | Synbiotic Supplement Group | Placebo Group |
|---|---|---|
| Started | 1 | 2 |
| Completed | 1 | 2 |
| Not completed | 0 | 0 |
Number of Participants who were accrued in 6 months
| Participants | Synbiotic Supplement Group | Placebo Group |
|---|---|---|
| Feasibility - Accrual | 1 | 2 |
Retain 85% of randomized participants for duration of study (6 weeks)
| Participants | Synbiotic Supplement Group | Placebo Group |
|---|---|---|
| Feasibility - Retention | 1 | 2 |
80% of participants consuming pills on 90% of intervention days
| Participants | Synbiotic Supplement Group | Placebo Group |
|---|---|---|
| Feasibility - Adherence | 1 | 2 |
Decrease in Generalized Anxiety Disorder-7 (GAD-7) score, which ranges from 0 (no anxiety) to 21 (severe anxiety).
No measurements were reported for this outcome.
Serum 5-hydroxytryptamine
No measurements were reported for this outcome.
Serum Tumor Necrosis Factor-alpha
No measurements were reported for this outcome.
Serum Lipopolysaccharide Binding Protein
No measurements were reported for this outcome.
Pro-inflammatory cytokine, Interleukin-6 (serum)
No measurements were reported for this outcome.
16s changes in microbiota alpha diversity
No measurements were reported for this outcome.
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Synbiotic Supplement Group | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Placebo Group | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Synbiotic Supplement Group | Placebo Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Synbiotic Supplement Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 55 (55 to 55) | 62.5 (58 to 67) | 60 (55 to 67) |
| Sex: Female, Male(Participants) | Synbiotic Supplement Group | Placebo Group | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Synbiotic Supplement Group | Placebo Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Synbiotic Supplement Group | Placebo Group | Total |
|---|---|---|---|
| United States | 1 | 2 | 3 |
| Generalized Anxiety Disorder Screener (GAD-7) Score(units on a scale (min=0; max=21)) | Synbiotic Supplement Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 8 | 8 ± 4.24 | 8 ± 3.0 |
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Auburn University