probiotic plus prebiotic supplement for Anxiety Disorders

1
Effectiveness
1
Safety
Auburn University, Auburn, AL
Anxiety Disorders+3 More
probiotic plus prebiotic supplement - DietarySupplement
Eligibility
18+
Female
Eligible conditions
Anxiety Disorders

Study Summary

Anti-anxiety Biotics for Breast Cancer Survivors

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Eligible Conditions

  • Anxiety Disorders
  • Breast Cancer
  • Breast Neoplasms
  • Generalized Anxiety
  • Malignant Neoplasm of Female Breast

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether probiotic plus prebiotic supplement will improve 3 primary outcomes and 6 secondary outcomes in patients with Anxiety Disorders. Measurement will happen over the course of 4 weeks.

4 weeks
Anxiety symptoms
Feasibility - adherence
Fecal microbiome composition
Inflammatory marker - IL-6
Inflammatory marker - LBP
Inflammatory marker - TNF-alpha
Serotonin
6 months
Feasibility - accrual
6 weeks
Feasibility - retention

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Placebo group
Synbiotic supplement group
Placebo group

This trial requires 48 total participants across 2 different treatment groups

This trial involves 2 different treatments. Probiotic Plus Prebiotic Supplement is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Synbiotic supplement group
DietarySupplement
Daily consumption of pills containing prebiotics and probiotics
Placebo group
DietarySupplement
Daily consumption of pills containing maltodextrin

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
A. F.
Prof. Andrew Fruge, Assistant Professor
Auburn University

Closest Location

Auburn University - Auburn, AL

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
agree not to change the type of dietary supplement you are taking during the course of the study. show original
I currently have symptoms of clinical anxiety, which are determined by the 7 item Generalized Anxiety Disorder screener show original
are willing to comply with daily supplement regimen
They can speak and read English. show original
They have completed their primary treatment. show original
The study found that those who are 50 years of age or older are more likely to suffer from anxiety disorders. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes anxiety disorders?

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To overcome anxiety disorders, it is important for patients to seek [help from therapists or a professional clinician. There is also treatment that focuses on specific parts of your emotional or behavioural system. We should use our knowledge of the disorders to create our own treatment plans as we develop more effective treatments. (https://www.ncbi.nlm.nih.gov/mesh/mshmm.htm).

Unverified Answer

What are the signs of anxiety disorders?

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Symptoms and signs of anxiety are more common than is commonly believed. The most commonly misdiagnosed condition is somatization by physicians. People suffering from these disorders need to be aware of these symptoms and signs, which can be avoided if more education is provided about anxiety disorders.

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What are common treatments for anxiety disorders?

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Anxiety disorders are treated with a variety of types of medications, behavioral therapy, CBT, psychotherapy, or combination. In some cases, specific medications may be used, but in others, cognitive-behavioral treatment may be most helpful.

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Can anxiety disorders be cured?

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No statistical data support a cure for obsessive-compulsive disorder or acute stress disorder. A combination of cognitive behavior therapy, exposure therapy, and mindfulness practices has been shown to be effective in preventing fear recurrences.

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What is anxiety disorders?

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Anxiety is a common mental disorder that consists of fear, fear of impending danger, and fear for the future. Anxiety is marked by excessive worry and avoidance.

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How many people get anxiety disorders a year in the United States?

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Approximately 7 million people have an anxiety disorder at some point during the year in the United States. This accounts for more than 20% of all outpatient visits to physicians. A substantial proportion of these visits are to a primary care provider and involve symptoms of anxiety or depression.

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How does probiotic plus prebiotic supplement work?

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Probiotic and prebiotic supplement may be a novel dietary supplement for treatment or prevention of anxiety disorders. Findings from a recent study provide evidence that prebiotics combined with probiotics may affect levels of anxiety and depression-specific behavior traits.

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What is the primary cause of anxiety disorders?

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There are several theoretical and conceptual issues with the diagnosis of anxiety disorders (DSM-5). At the core of anxiety is a constant concern, fear, and alarm, often coupled with a sense that events are not predictable and difficult to escape. Anxiety is not a simple or one-dimensional disorder. Anxiety is multi-dimensional and has many overlapping signs and symptoms. There needs to be a concerted effort to educate the public and treat practitioners that it is a complex disorder, with many possible causes, and some of them are still unknown.

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What does probiotic plus prebiotic supplement usually treat?

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A meta-analysis concluded that probolic supplementation did not show beneficial effects in anxiety conditions, both in individual studies and in the full dataset. A recent study reported benefit on anxiety symptoms in healthy people, and it may also work in clinical trials. A review of both positive and negative studies showed that there was no compelling evidence supporting or dismissing the benefits of probiotics to treat anxiety disorders. We found no data on probiotics to treat other disorders, such as diabetes, metabolic or cardiovascular disorders, or neurological disorders. While the first published study found benefit, there were no follow-up studies, and it may be that the patients benefited only a few days and not long term when consuming the product.

Unverified Answer

What is probiotic plus prebiotic supplement?

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Probiotic plus prebiotic supplements (PROMES) were acceptable to participants. The supplement had little direct effect on anxiety or insomnia, but participants reported significant improvement in sleep quality, fatigue, and depressive symptoms.

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What are the latest developments in probiotic plus prebiotic supplement for therapeutic use?

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The prebiotic + probiotic nutritional supplements represent the new drugs in the area of functional foods, which in turn lead to the better use and application of probiotic microorganisms in human food to improve health and food digestibility.

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Have there been other clinical trials involving probiotic plus prebiotic supplement?

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There are only three clinical trials involving probiotic plus prebiotic supplement used as a treatment to manage/improve general and anxiety symptoms and to optimize gut microbiota. However, such trials should be further investigated with more rigorous design and statistical methodology. These trials include the treatment of IBS with probiotic+prebiotic supplements. For instance, two of the four trials reported by Zhang et al. were controlled with placebo. These placebo controlled trials were also designed to test the efficacy of probiotics. On the other hand, the placebo control design was not used or was reported in only one trial.

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See if you qualify for this trial
Get access to this novel treatment for Anxiety Disorders by sharing your contact details with the study coordinator.