NCT05022524

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

Exploring Novel Uses of Microbiota Therapy for Managing the Side Effects of Psychiatric Pharmaceutical Interventions: An N-of-1 Pilot and Feasibility Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 16 Years – 25 Years
• Healthy volunteers: Not accepted

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

Conditions

• Depression, Anxiety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Acetate (Apple Cider Vinegar)	Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-06-30
• Completion: 2024-08-31
• First posted: 2021-08-26
• Last updated: 2023-10-05

Locations

1 site across 1 country: Canada