Exploring Novel Uses of Microbiota Therapy for Managing the Side Effects

Status Recruiting

Clinical Trial Summary

To determine the feasibility of whether the addition of key prebiotics administered orally can mitigate some of the most problematic side-effects of the most common psychiatric medications - weight gain and metabolic abnormalities caused by some antidepressants, mood stabilizers and antipsychotics. In the initial part of the study, we aim to determine feasibility of the study and evaluate participant compliance. Our clinical trial will encourage the growth of Akkermansia muciniphila (AM) through enteric-coated orally-administered acetate (apple cider vinegar powder in capsules) in 16-to-28 year-old patients who have already experienced weight gain while on stable doses of psychiatric medication, with the hypothesis that the addition of this prebiotic will result in alterations in gut microbiota and measurable weight loss, as well as improvement in metabolic measurements. Primary Objective: - To evaluate feasibility of using acetate in a large-scale clinical trial, including considerations for protocol, study agent, recruitment, retention, adverse events, budget, staff, facility, and patient experience - To estimate effect size of change in AM relative abundance by measuring pre- and post-intervention levels for use in designing future large-scale clinical trials Secondary Objectives: - To determine whether acetate administered orally shows an observable effect on weight gain as a side effect from antidepressants, mood stabilizers, and/or antipsychotics in a sample of participants already on stable doses of at least one of these medications - To determine changes in metabolic syndrome profile, as indicated by blood pressure and high-density lipoprotein. - To conduct preliminary analyses on any possible changes in mood/anxiety symptoms pre- versus post-intervention - To identify and define other potential confounders or effect modifiers of our primary and secondary objectives that should be considered in future study designs

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05022524
Study type	Interventional
Source	Lawson Health Research Institute
Contact	Elizabeth Osuch, MD
Phone	519-646-6000
Email	elizabeth.osuch@lhsc.on.ca
Status	Recruiting
Phase	Phase 1
Start date	June 1, 2022
Completion date	August 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Exploring Novel Uses of Microbiota Therapy for Managing the Side Effects of Psychiatric Pharmaceutical Interventions

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms