Exploring Novel Uses of Microbiota Therapy for Managing the Side Effects of Psychiatric Pharmaceutical Interventions: An N-of-1 Pilot and Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility: Recruitment success
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For an eligible patient, all inclusion criteria must be answered "yes"
- •Signed informed consent obtained prior to any study-related activities
- •Patients of FEMAP who are between the ages of 16 and 28
- •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
- •Have a body mass index of ≥ 21.7 kg/m2 (midpoint of normal BMI (18.5-24.9).
排除标准
- •Participants who are unable to follow multi-step instructions independently, as determined by the treating psychiatrist.
- •Participants who are pregnant or planning to get pregnant
- •Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.
- •Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa
- •Currently on a weight-loss diet plan i.e. ketogenic diet, detox diet
- •Currently using a medication for weight loss i.e. Contrave (bupropion / naltrexone), Saxenda (liraglutide)
- •Current use of dietary supplements for weight loss i.e. garcinia cambogia; or use within 4 weeks prior to study initiation
- •Bowel surgery
- •Crohn's disease or other bowel conditions
- •Blood/bleeding/liver/kidney disorders
- •Currently enrolled in other clinical trial which may affect their study outcome
结局指标
主要结局
Feasibility: Recruitment success
时间窗: 5 months
Number of potential participants approached to number expressing interest, and number invited to number recruited (recruitment success)
Feasibility: Retention
时间窗: 5 months
Number recruited to number retained (attrition)
Feasibility: Adherence
时间窗: 5 months
Number adhering to intervention protocol quantified through number of capsules returned at end of trial
Feasibility: Adverse Events
时间窗: 5 months
A study-specific data form for collecting adverse events
Akkermansia Muciniphila abundance
时间窗: 5 months
Relative abundance (proportion) of AM in stool at inception compared to all other species identified, and change in relative abundance from pre- to post-intervention
次要结局
- Mood: Anxiety(5 months, captured monthly)
- Body Weight(5 months, recorded monthly)
- Metabolic Indicator: Blood pressure(5 months)
- Metabolic Indicator: High-Density Lipoproteins(5 months)
- Mood: Depression(5 months, captured monthly)