Using probiotics to manage weight gain from psychiatric medications

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

This study is testing if a prebiotic from apple cider vinegar can help young people who have gained weight from psychiatric medications lose weight and improve their health.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 16 Years to 25 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT05022524 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to explore the feasibility of using prebiotics, specifically acetate derived from apple cider vinegar, to alleviate weight gain and metabolic issues associated with common psychiatric medications. Participants aged 16 to 28 who have experienced problematic weight gain while on stable doses of antidepressants, mood stabilizers, or antipsychotics will be enrolled. The study will assess the impact of the prebiotic on gut microbiota and its potential to induce weight loss and improve metabolic health. The primary objective is to evaluate the feasibility of this approach for future large-scale trials.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16 to 28 who have gained significant weight while on stable psychiatric medication.

Not a fit: Patients who are pregnant, have active eating disorders, or are on medications that promote weight loss may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help patients manage weight gain and metabolic side effects from psychiatric medications more effectively.

How similar studies have performed: While the use of probiotics in psychiatric care is an emerging field, similar studies exploring gut microbiota's role in managing medication side effects have shown promising results.

Eligibility criteria

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

Where this trial is running

London, Ontario

• First Episode Mood and Anxiety Disorders Program (FEMAP) — London, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Elizabeth Osuch, MD

Conditions Depression, Anxiety; Probiotics; Psychiatry; Weight