Anti-anxiety Biotics for Breast Cancer Survivors

Breast Cancer Female Clinical Trial

— ABBCS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04784182
• Other study ID #: 21-110
• Secondary ID: UL1TR003096-03
• Status: Terminated
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2023
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

Female breast cancer survivors or female relatives of a breast cancer survivor who:

1. are 50 years of age or older

2. have completed primary treatment

3. currently experience clinical anxiety symptoms determined by the 7 item Generalized Anxiety Disorder screener (GAD-7; eligibility requires a total score of 5 or higher on the 21 point scale)

4. agree not to change dietary supplements throughout the course of the study

5. are willing to comply with daily supplement regimen

6. are able to speak and read English.

Exclusion Criteria:

1. use of any of the following drugs within the last 4 weeks (unless indefinitely prescribed): systemic antibiotics, corticosteroids, immunosuppressive agents, or commercial probiotics

2. changes in treatment for anxiety symptoms (i.e. initiation of Cognitive Behavior Therapy (CBT) within the last four weeks

3. current use (within 12 weeks) of anxiolytic medications.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Generalized
• Breast Cancer Female
• Breast Neoplasms

Intervention

Dietary Supplement:
• 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)
• placebo
Daily consumption of visually similar placebo pills

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Auburn University	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Accrual	Number of Participants who were accrued in 6 months	6 months
Primary	Feasibility - Retention	Retain 85% of randomized participants for duration of study (6 weeks)	6 weeks
Primary	Feasibility - Adherence	80% of participants consuming pills on 90% of intervention days	4 weeks
Secondary	Anxiety Symptoms	Decrease in Generalized Anxiety Disorder-7 (GAD-7) score, which ranges from 0 (no anxiety) to 21 (severe anxiety).	4 weeks
Secondary	Serotonin	Serum 5-hydroxytryptamine	4 weeks
Secondary	Inflammatory Marker - TNF-alpha	Serum Tumor Necrosis Factor-alpha	4 weeks
Secondary	Inflammatory Marker - LBP	Serum Lipopolysaccharide Binding Protein	4 weeks
Secondary	Inflammatory Marker - IL-6	Pro-inflammatory cytokine, Interleukin-6 (serum)	4 weeks
Secondary	Fecal Microbiome Composition	16s changes in microbiota alpha diversity	4 weeks

External Links

•   Study website