Gut Health and the Effect on Substance and Alcohol Cravings
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Decrease in substance or alcohol cravings
研究概览
简要总结
Gut health has been linked with improvement in mental health but no research has been done to evaluate if improving gut health can have an effect on alcohol and substance cravings. This pilot study is to evaluate if any decrease in cravings can be found with probiotics/prebiotics by improving gut health. Participants will take a pre-survey to evaluate their cravings. Participants will then be started on a regimen of probiotic and prebiotic with a pickle daily for 30 days to improve gut health. Then participants will take the same survey to evaluate if there has been any decrease in cravings.
详细描述
Consent and a pre survey on cravings will be collected. Then participants will take a probiotic/prebiotic and a pickle for 30 days. Participants will be given a probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion colony forming unit and inulin 250mg along with a pickle daily for 30 days. After 30 days the same survey will be taken by the participants and a paired t test will be used to analyze if there is a statistical change in cravings. Participants will be in a recovery program with a prior history of substance or alcohol abuse and will be abstaining from drugs and alcohol.
The purpose of the study is to evaluate if improving gut health by the above intervention can also decrease substance and alcohol cravings. Probiotics and prebiotics have been shown to improve mental health with a decrease in depression and PTSD but no studies have investigated if improving gut health can decrease substance or alcohol cravings. Probiotics are a cheap intervention that many recovery centers with limited recourses would be able to use. Fermented foods like pickles have been shown to have significant benefit to gut health with improvement in the gut biome. Pickles are also affordable which is why this combination was chosen to be studied.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females age 18-75 years old
- •current cravings for substance or alcohol use
- •enrolled in a recovery clinic
- •able to understand and comply with the requirements of the study
- •provision of written informed consent.
排除标准
- •Any alcohol or substance use in the past week
- •any narcotic use (including methadone and buprenorphine)
- •daily probiotic product use in the last 2 weeks
- •women who are pregnant or planning to become pregnant during the trial
- •if they already have no alcohol or substance cravings
- •non English speakers.
结局指标
主要结局
Decrease in substance or alcohol cravings
时间窗: 30 days
Evaluation via the same survey before and after probiotic and a pickle for 30 days to see if there is any change in cravings. A pre and post survey will be administered with cravings rated with a scale of 1-5, no cravings would be the number one to extreme cravings with a number of 5. A paired t-test will then be used to analyze the data.
次要结局
未报告次要终点
研究者
Anna McCarthy
Principal Investigator
City Rescue Mission Medical Clinic