Anti-anxiety Biotics for Breast Cancer Survivors

NCT04784182 | Terminated Results

• 2 other identifiers: 21-110UL1TR003096-03
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anxiety Generalized; Breast Cancer Female

Outcome Measures

Primary Outcomes (3)

• Feasibility - Accrual

  Number of Participants who were accrued in 6 months

  6 months

• Feasibility - Retention

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

  6 weeks

• Feasibility - Adherence

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

  4 weeks

Secondary Outcomes (6)

• Anxiety Symptoms

  4 weeks

• Serotonin

  4 weeks

• Inflammatory Marker - TNF-alpha

  4 weeks

• Inflammatory Marker - LBP

  4 weeks

• Inflammatory Marker - IL-6

  4 weeks

Study Arms (2)

Synbiotic supplement group

EXPERIMENTAL

Daily consumption of pills containing prebiotics and probiotics

Dietary Supplement: probiotic plus prebiotic supplement

Placebo group

PLACEBO COMPARATOR

Daily consumption of pills containing maltodextrin

Dietary Supplement: placebo

Interventions

probiotic plus prebiotic supplement DIETARY_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

placebo DIETARY_SUPPLEMENT

Daily consumption of visually similar placebo pills

Placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female breast cancer survivors or female relatives of a breast cancer survivor who:
• are 50 years of age or older
• have completed primary treatment
• 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)
• agree not to change dietary supplements throughout the course of the study
• are willing to comply with daily supplement regimen
• are able to speak and read English.

You may not qualify if:

• use of any of the following drugs within the last 4 weeks (unless indefinitely prescribed): systemic antibiotics, corticosteroids, immunosuppressive agents, or commercial probiotics
• changes in treatment for anxiety symptoms (i.e. initiation of Cognitive Behavior Therapy (CBT) within the last four weeks
• current use (within 12 weeks) of anxiolytic medications.

Sponsors & Collaborators

• Auburn University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

Related 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.

  PMID: 31858898 BACKGROUND

Related Links

• Study website

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

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

Results Point of Contact

• Title: Drew Frugé
• Organization: Auburn University

adf0003@auburn.edu

3348448433

Study Officials

• Andrew D Frugé, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One study staff member will be responsible for randomization and allocation of intervention supplement or placebo, which will be appear to be identical
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Placebo controlled randomized controlled trial

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: July 20, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 24, 2023
• Results First Posted: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)