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Microbiota Therapy with Acetate for Depression and Anxiety

Phase 1
Recruiting
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a body mass index of ≥ 21.7 kg/m2 (midpoint of normal BMI (18.5-24.9))
Patients of FEMAP who are between the ages of 16 and 28
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights

Study Summary

This trial will study the feasibility of using acetate to encourage the growth of Akkermansia muciniphila in order to mitigate weight gain and metabolic abnormalities caused by psychiatric medications.

Who is the study for?
This trial is for 16-to-28 year-olds who are on a stable dose of antidepressants, mood stabilizers, or antipsychotics and have gained significant weight (over 5% of initial body weight) after starting their medication. They must have a BMI ≥ 21.7 kg/m2 and not be on any diet or medications for weight loss, nor have certain medical conditions like Crohn's disease or active eating disorders.Check my eligibility
What is being tested?
The study tests if apple cider vinegar powder capsules can help manage side effects from psychiatric drugs, specifically unwanted weight gain and metabolic issues. It aims to promote the growth of beneficial gut bacteria in patients already experiencing these side effects to see if it leads to weight loss and better metabolism.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to the introduction of prebiotic acetate (apple cider vinegar). Since this is an exploratory trial, other specific side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is at least 21.7.
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I am between 16 and 28 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Akkermansia Muciniphila abundance
Feasibility: Adherence
Feasibility: Adverse Events
+2 more
Secondary outcome measures
Body Weight
Metabolic Indicator: Blood pressure
Metabolic Indicator: High-Density Lipoproteins
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transition-Age AdultsExperimental Treatment1 Intervention
16-25 year old patients on stable dose of antipsychotic medication for treatment of depression or anxiety.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
655 Previous Clinical Trials
413,329 Total Patients Enrolled

Frequently Asked Questions

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

What objectives are investigators hoping to accomplish with this research?

"Over a period of 5 months, the primary outcome in this study is measuring retention. Secondary outcomes involve assessing patient depression using Quick Inventory of Depressive Symptomatology (QIDS-SR), anxiety levels with Overall Anxiety Severity and Impairment Scale (OASIS) as well as tracking blood pressure via medical-grade arm cuff."

Answered by AI

Who is eligible to partake in this research initiative?

"This investigation is accepting 10 adolescent patients suffering from depression. To be admissible, all of the following conditions must be met: 'Yes' responses to each inclusion criteria, signed informed consent prior to any trial-related activities, between 16 and 28 years old and registered with FEMAP, a stable dose of antidepressant/mood stabilizer/antipsychotic drugs plus recent (approx 5%) weight gain linked temporally with initiating said drug as confirmed by psychiatrist, BMI ≥ 21.7 kg/m2 (midpoint normal range)."

Answered by AI

Is there any risk associated with the ingestion of Acetate (Apple Cider Vinegar)?

"Acetate (Apple Cider Vinegar) safety is still being tested, thus receiving a score of 1 on our team's scale. This Phase 1 trial has limited evidence in regards to its efficacy and safety."

Answered by AI

Is the upper age limit for participation in this study more than 75 years?

"The study is looking for candidates within the age range of 16 to 25 years old."

Answered by AI

Is the patient recruitment phase of this trial still underway?

"According to information hosted on clinicaltrials.gov, this medical trial is no longer enrolling participants as it was last updated on August 29th 2022. However, there are 1169 other trials taking part in the recruitment of patients at present."

Answered by AI

Who else is applying?

What site did they apply to?
First Episode Mood and Anxiety Disorders Program (FEMAP)
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1 spots leftby Jun 2024