Open Label Single Arm Prebiotic Pilot Trial SR001

N/AActive Not RecruitingNCT07127120

Sorridi Therapeutics20 enrolled

Overview

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: 1. To assess the safety and tolerability of consuming 1 fiber bar/day 2. To determine if a prebiotic fiber blend impacts biological metrics and non-motor symptoms of Parkinsons Disease 3. 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.

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.

Interventions

Prebiotic fiber blendDIETARY_SUPPLEMENT

Proprietary blend of 5 prebiotic fibers and normal bar excipients Product name: NeuroFiber Dosage form: Single bar/day Storage conditions: The Study Product delivered by Sorridi to patient/subject at the beginning of study. Any remainder will be collected by Sorridi at end of study. Product is to be stored at room temperature in the patient's/subject's homes. The bar will be produced and packaged at a licensed contract manufacturer experienced in producing nutritional supplements. Labelling will be carried out by Sorridi Therapeutics.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 1. * 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

Outcomes

Primary Outcomes

Tolerability of Prebiotic Fiber bar in Parkinson's Patients

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.

Time frame: From enrollment to 4 weeks on intervention

Safety of Prebiotic Fiber bar in Parkinson's Patients

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.

Time frame: 4 weeks

Secondary Outcomes

Changes in biomarkers of intestinal inflammation

Change in fecal calprotectin levels, as a marker of intestinal inflammation. Change in fecal zonulin levels, as a measure of gut barrier permeability. Both are measured in ug/g. Higher levels of calprotectin (over 50 ug/g) are indicative of gut inflammation. A decrease in the levels will be interpreted as improvement of intestinal inflammation. Higher levels of zonulin (over 110 ug/g) are indicative of more intestinal barrier permeability (leakier gut). A decrease in the levels will be interpreted as strengthening of the gut barrier.

Time frame: 4 weeks

Changes in gut microbiome composition

Changes in relative abundance and species composition of microbiome, measured in fecal samples. The microbiome will be evaluated using 16s rRNA sequencing and shotgun metagenomics.

Time frame: 4 weeks

Changes in fecal metabolites

Changes in levels of short chain fatty acids (SCFA). SCFA concentration(mmol/g) in fecal samples collected at baseline and after 4 weeks will be measured using GC/MS. Levels of individual SCFA (acetate, butyrate, propionate) as well as total levels will be compared at baseline to 4 weeks. Increases in total SCFA levels as well as increases in specific individual SCFA will be interpreted as positive impacts of the fiber formulation consumption.

Time frame: 4 weeks

Open Label Single Arm Prebiotic Pilot Trial SR001

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes