Recruiting
Phase 1

Microbiota Therapy

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT05022524

Conditions

Depression, Anxiety

Eligibility Criteria

Sex: All

Age: 16 - 25

Healthy Volunteers: Not accepted

Interventions

Acetate (Apple Cider Vinegar)

Study Details

Brief 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

Study ID

NCT05022524

Start date

Jun 1, 2022

Status verified date

Oct, 2023

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

For an eligible patient, all inclusion criteria must be answered "yes"

1. Signed informed consent obtained prior to any study-related activities
2. Patients of FEMAP who are between the ages of 16 and 28
3. Currently on a stable dose of an antidepressant, mood stabilizer, and/or antipsychotic drug AND have experienced what they deem to be problematic weight gain (approximately greater than 5% of initial body weight) that was temporally linked with initiating the drug, as confirmed by a psychiatrist
4. Have a body mass index of ≥ 21.7 kg/m2 (midpoint of normal BMI (18.5-24.9).

Exclusion Criteria:

1. Participants who are unable to follow multi-step instructions independently, as determined by the treating psychiatrist.
2. Participants who are pregnant or planning to get pregnant
3. Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.
4. Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa
5. Currently on a weight-loss diet plan i.e. ketogenic diet, detox diet
6. Currently using a medication for weight loss i.e. Contrave (bupropion / naltrexone), Saxenda (liraglutide)
7. Current use of dietary supplements for weight loss i.e. garcinia cambogia; or use within 4 weeks prior to study initiation
8. Bowel surgery
9. Crohn's disease or other bowel conditions
10. Blood/bleeding/liver/kidney disorders
11. Currently enrolled in other clinical trial which may affect their study outcome

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transition-Age Adults

16-25 year old patients on stable dose of antipsychotic medication for treatment of depression or anxiety.

Interventions

Acetate (Apple Cider Vinegar)

Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract.

Primary outcome measure

  • Feasibility: Recruitment success [ Time Frame: 5 months ]
  • Feasibility: Retention [ Time Frame: 5 months ]
  • Feasibility: Adherence [ Time Frame: 5 months ]
  • Feasibility: Adverse Events [ Time Frame: 5 months ]
  • Akkermansia Muciniphila abundance [ Time Frame: 5 months ]

Central Contacts and Locations

Central contacts

Elizabeth Osuch, MD

519-646-6000elizabeth.osuch@lhsc.on.ca

Locations

First Episode Mood and Anxiety Disorders Program (FEMAP)

Recruiting

London, Ontario, Canada, N6A 3H8

Contacts

Elizabeth A Osuch, MD

+1-519-646-6000FEMAP@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Oct 5, 2023

Last verified

Oct, 2023

Keywords

  • Probiotics
  • Psychiatry
  • Weight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2023-10-05.