Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784182
Status:
TERMINATED
Last Update Posted:
2023-08-24
First Post:
2021-03-02
Brief Title:
Anti-anxiety Biotics for Breast Cancer Survivors
Sponsor:
Auburn University
Organization:
Auburn University
Study Overview
Official Title:
Synbiotic Supplementation to Reduce Anxiety Symptoms in Female Breast Cancer Survivors andor Their Female Relatives
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only three participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABBCS
Brief 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 andor 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
This is a double-blind placebo-controlled clinical trial in which female breast cancer survivors andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR003096-03 | NIH | None | httpsreporternihgovquickSearchUL1TR003096-03 |