A Single Arm, Open Label Study to Assess the Tolerability of a Prebiotic in Adults With Parkinson's Disease and Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tolerability of Prebiotic Fiber bar in Parkinson's Patients
研究概览
简要总结
The goal of this pilot clinical study is to evaluate the effect of a prebiotic fiber blend in individuals diagnosed with Parkinson's Disease. The main objectives of this pilot study are:
- To assess the safety and tolerability of consuming 1 fiber bar/day
- To determine if a prebiotic fiber blend impacts biological metrics and non-motor symptoms of Parkinsons Disease
- To evaluate the effect of the fiber bar on intestinal inflammation
Participants will have blood and fecal samples collected at baseline and after 4 weeks of intervention. Participants will also complete questionnaires to monitor GI symptom severity, quality of life metrics, and Parkinson's-specific surveys. Researchers will compare biomarkers and reported assessment answers at baseline and after 4 weeks with intervention.
详细描述
Recent evidence has unveiled a major role of gut-brain crosstalk in the pathology of Parkinson's Disease (PD). The gastrointestinal tract is home to a diverse and complex community of microorganisms, termed the microbiota. The microbiota performs numerous functions, like digestion and metabolism of food and immune system regulation. Moreover, the microbiota produces vital molecules like neurotransmitters and metabolites that contribute to intestinal, neural, and systemic health. Dysbiosis, or an imbalanced microbiome, is common in patients with PD, and one of the major non-motor symptoms associated with PD is constipation. It is believed that an increase in pro-inflammatory bacteria and a decrease in anti-inflammatory bacteria contribute to the symptoms and pathology of PD, with recent research focusing on bacteria that produce short chain fatty acids (SCFA). SCFA are beneficial metabolites that are used as fuel by host intestinal cells, modulate inflammation, and promote overall health. Dietary fibers are the primary nutrient that is broken down by bacteria to produce SCFA. Therefore, we have formulated a prebiotic fiber blend to specifically enhance the growth and metabolism of SCFA-producing bacteria, with the aim to improve gastrointestinal health in patients with Parkinson's Disease. In this pilot clinical study, participants with PD will consume 1 fiber bar per day for 4 weeks. Questionnaires will be utilized to monitor tolerability, gastrointestinal symptoms, motor and non-motor metrics of PD. Blood and fecal samples will be collected at baseline and again after 4 weeks of consuming the fiber bar daily. The data collected during this pilot trial will be used to inform future, larger trials on the effectiveness of prebiotic fiber formulations to modulate the microbiome of PD patients, with the ultimate goal of reducing severity of PD symptoms and delaying the progression of neurodegeneration.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Parkinson's Disease by a Neurologist
- •Be able to give written informed consent
- •Be aged between 60-75 years
- •Participants are on a stable drug regimen
- •Willing to consume the study product daily for the duration of the study
- •Willing to abstain from pre and probiotics for 2 weeks prior to the study and throughout the 28 days of the intervention
排除标准
- •Participants has acute or chronic gastrointestinal disease (coeliac disease, diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers) except for hiatal hernia, gastroesophageal reflux disease, haemorrhoids.
- •Participants who have consumed probiotic supplements and prebiotic supplements within 2 weeks prior to Visit
- •Participant suffering from severe renal disease (creatinine greater than 2.5 times normal)
- •Participants with markedly abnormal liver function (alt/ast greater than 2.5 times normal)
- •Plan to have a major change in dietary habits during the study.
- •Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •Participants may not be receiving treatment involving experimental drugs/supplements. If the Participant has been in a recent experimental study, these must have been completed not less than 90 days for drugs and 30 days for supplements prior to this study.
- •Consumption of non-standard diet (vegetarian, vegan, gluten free, or paleo)
- •Elevated bilirubin
研究组 & 干预措施
Prebiotic Fiber Bar
Open-label consumption of prebiotic fiber bars
1 bar/day for 4 weeks
干预措施: Prebiotic fiber blend (Dietary Supplement)
结局指标
主要结局
Tolerability of Prebiotic Fiber bar in Parkinson's Patients
时间窗: From enrollment to 4 weeks on intervention
The tolerability of consuming 1 fiber bar/day for 4 weeks. Impacts on bowel movement frequency, stool consistency (Bristol Stool Scale), gastrointestinal symptoms of bloating, cramping, flatulence will be evaluated using a GI questionnaire. Measures are reported as # of days, # of events, and severity scale of 1-4. 1=never, 2=infrequent, 3=a few times, 4=often. Values for each metric in the questionnaire will be totaled to achieve an overall GI score. A higher score is indicative of worse GI effects. A decrease in overall score will indicate improvement in GI symptoms, and will be interpreted as tolerability of prebiotic consumption.
Safety of Prebiotic Fiber bar in Parkinson's Patients
时间窗: 4 weeks
The safety of consuming 1 fiber bar/day for 4 weeks. Safety will be evaluated based on frequency of adverse events over the course of the study. Potential adverse events could include worsening of gastrointestinal distress and discomfort, changes from baseline blood metabolic measures to abnormal ranges that could indicate liver or kidney dysfunction, diabetes, etc.
次要结局
- Changes in gut microbiome composition(4 weeks)
- Changes in fecal metabolites(4 weeks)
- Changes in biomarkers of intestinal inflammation(4 weeks)