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NCT04784182 · ClinicalTrials.gov registry record · NA
Anti-anxiety Biotics for Breast Cancer Survivors
A NA study, sponsored by Auburn University.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT04784182 is a NA study that was terminated before completion, run by Auburn University. The registered enrollment target is 3 participants.
The verdict
NCT04784182, a NA study, was terminated before completion, sponsored by Auburn University.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
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.
Interventions
- DIETARY_SUPPLEMENT placebo
- DIETARY_SUPPLEMENT probiotic plus prebiotic supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-07-20 |
| Est. Completion | 2022-05-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04784182
The ClinicalTrials.gov registry entry for NCT04784182 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Auburn University, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT04784182 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04784182 about?
NCT04784182 is a clinical study titled "Anti-anxiety Biotics for Breast Cancer Survivors". 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 tar...
What is the current status of trial NCT04784182?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2021-07-20. Estimated completion is 2022-05-01.
What interventions are being tested in trial NCT04784182?
The interventions under investigation include: placebo (DIETARY_SUPPLEMENT), probiotic plus prebiotic supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04784182?
This trial is sponsored by Auburn University, which has 54 total clinical trials registered on ClinicalTrials.gov.
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