Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1376682 | Other Identifier | WCG IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Illinois Institute of Technology, Chicago, USA | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic Fiber Bar | Experimental | Open-label consumption of prebiotic fiber bars 1 bar/day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic fiber blend | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum markers of neuroinflammation | Change in serum biomarkers of neuroinflammation: levels of neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP). Both are measured in pg/mL. High levels of NfL (over 4 pg/mL) and high levels of GFAP (over 87 pg/mL) are indicative of neurodegeneration. A decrease in levels will be interpreted as improvements in brain health and slowing of progression of neurodegeneration. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorridi Therapeutics | Northbrook | Illinois | 60062 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D007249 | Inflammation |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 4 weeks |
| 4 weeks |
| Impacts on non-motor symptoms associated with Parkinson's Disease | Changes in sleep quality, measured with the Parkinsons Disease Sleep scale (PDSS-2) questionnaire. Metrics of sleep disturbances are measured from 0-10, with 0=always and 10=never. Scores for each metric will be added together for a number total. Lower scores are indicative of more sleep disturbances, and worse symptoms. Totals will be compared from baseline to 4 weeks. Increases in total scores will be interpreted as improvements in sleep problems. | 4 weeks |
| Change in symptoms of Parkinson's Disease | Changes in motor and non-motor symptoms of Parkinson's Disease will be evaluated using the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire. Metrics are scored from 0-4. 0=Normal or nonexistent, 1=slightly problematic, 2=mildly problematic, 3=moderately problematic, 4=severely problematic. Scores from Part I (non-motor experiences), Part II (motor experiences), Part III (motor examination), and Part IV (motor complications) will be totaled. Lower scores indicate less problematic symptoms. Totals will be compared from baseline to four weeks. Decreases in scores will be interpreted as improvements in symptom severity. | 4 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |