Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512599
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2020-07-31
Brief Title:
Prebiotics in the Parkinsons Disease Microbiome
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Short Chain Fatty Acid Enhancing Prebiotics and Normalization of Parkinsons Disease Microbiome A Pilot Tolerability Study
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are about one million Parkinsons disease PD patients in America The risks associated with whether or not an individual may develop PD include environment and genetic biologic hereditary factors Studies have show that certain things may be triggers for example cells in the brain that are made active and associated inflammation in the brain The gut is the largest interface between the PD patient and the environment and it is highly thought to be pathway to the environment trigger Research studies have looked at how information is passed back and forth between the brain and the gut
The goal of this study pilot is to gather information to conduct a larger clinical trial For this pilot study is to determine if a microbiota-directed bacteria in the gut intervention dietary bar is capable of correcting the bacteria gut balance in PD This is based on the thought that an imbalance of bacteria in the gut of PD patients may lead to the gut and intestines working correctly The long term goal is to see if the intervention has the potential to modify the disease or protect the brain in PD If the intervention successfully improves the bacterial imbalance in PD it will be the first attempt to modify the Gut-Brain communication in PD which can lead to additional studies aimed at improving the disease progression or prevention
In this project the investigators will test how well Parkinsons disease patients tolerate changes in the gut and intestines by providing the participants a dietary bar to eat for 10 days The investigators intend to conduct this pilot clinical trial in which the investigators believe that daily oral intake of a prebiotic mixture will be safe and well tolerated in a small number Parkinsons disease participants prior to a larger clinical trial looking at efficacy
The goal of this study pilot is to gather information to conduct a larger clinical trial For this pilot study is to determine if a microbiota-directed bacteria in the gut intervention dietary bar is capable of correcting the bacteria gut balance in PD This is based on the thought that an imbalance of bacteria in the gut of PD patients may lead to the gut and intestines working correctly The long term goal is to see if the intervention has the potential to modify the disease or protect the brain in PD If the intervention successfully improves the bacterial imbalance in PD it will be the first attempt to modify the Gut-Brain communication in PD which can lead to additional studies aimed at improving the disease progression or prevention
In this project the investigators will test how well Parkinsons disease patients tolerate changes in the gut and intestines by providing the participants a dietary bar to eat for 10 days The investigators intend to conduct this pilot clinical trial in which the investigators believe that daily oral intake of a prebiotic mixture will be safe and well tolerated in a small number Parkinsons disease participants prior to a larger clinical trial looking at efficacy
Detailed Description:
Intestinal microbiota are a dynamic community of commensal bacteria that modulate gut homeostasis and systemic biological processes including brain development and function through a bidirectional Gut-Brain axis Recent studies in both rodent models of disease and human have shown disrupted intestinal microbiota community in multiple systemic metabolic and inflammatory disorders including neurological disease More specifically emerging evidence shows that stool and intestinal mucosal associated microbiota composition and function are abnormal in PD patients Divergence of commensal bacteria composition from the microbial communities found in healthy persons so called dysbiosis has been associated with PD in early and late stages as well as in patients with Rapid Eye Movement REM sleep behavior disorder RBD a group that are at high risk of progression to PD
In this project the investigators will test the tolerability of Parkinsons disease patients in modulating the gut microbiota through dietary means The investigators intend to conduct a pilot clinical trial in which the investigators hypothesize that daily oral intake of a prebiotic mixture will be safe and well tolerated in a small number Parkinsons disease participants prior to a larger clinical trial looking at efficacy
Research design and protocol
The study is an open-label non-randomized study in 20 Parkinsons disease participants at Rush University Medical Center RUMC under the supervision of Drs Hall and Keshavarzian The trial will include 10 PD patients who are de novo not yet on medication or moderate stage on medications Participants will take the prebiotics in a form of a bar Table 1 for 10 days- one bar 10 gram fiber a day for 3 days and then one bar twice a day for additional one week
Each participant will have a baseline visit and a follow up visit after 10 days of the intervention consumption of prebiotic dietary bar At each visit participants will complete questionnaires regarding adverse events including a questionnaire that rates bowel movement stool consistency discomfort flatulence abdominal pain and bloating on a scale from 1 best to 10 worst Participants will also complete a Perceived Stress Questionnaire Appendix D and GI Symptom and Severity Checklist Appendix A Participants will be asked to fill out a diet record 24ASA diet questionnaire Appendix E during the last 3 days on the intervention Participant will also are asked to self-collect stool at home before consuming eating the first probiotic bar in the study and during the last day of the study at home Supplies for stool collection 2 stool collection kit and instructions for specimen handling and for completing these tasks will be given at Visit 1 and refreshed before visit 2 At visit 1 participants will be provided with 2 stool collection kits First stool will be collected at home about 1 day and participants are asked to mail the stool in a pre-paid Fed Ex right after collecting the stool The second stool collection will be on the last day that participants consume the probiotic bars prior to coming to for study visit 2 when the participants bring the stool to the study visit The kit includes supplies to preserve the sample with gas packs and collection bag so the sample can be brought with the participant to the visits within 24 hours The self-collected stool samples will be saved by the study team and frozen for future use Participants will be asked to complete several dietary questionnaires including a Mediterranean diet screener Appendix F food timing screener Appendix B and food frequency questionnaire Appendix C Before Visit 2 each participant will collect the stool and complete the 3-day food record these will be returned at Visit 2 At Visit 2 participants will complete a Perceived Stress Questionnaire Appendix D and GI Symptom and Severity Checklist and associated instructions Appendix A Each participant will also have blood draw 1 red top to collect serum and 1 EDTA tube to collect plasma at visit 1 baseline and at visit 2 completion of the study to check for serum short chain fatty acids lipopolysaccharides interleukins and cytosine monophosphatecheck for safety
Participants will provide written informed consent Visit 1 before any study procedures data or sample collection are performed
In this project the investigators will test the tolerability of Parkinsons disease patients in modulating the gut microbiota through dietary means The investigators intend to conduct a pilot clinical trial in which the investigators hypothesize that daily oral intake of a prebiotic mixture will be safe and well tolerated in a small number Parkinsons disease participants prior to a larger clinical trial looking at efficacy
Research design and protocol
The study is an open-label non-randomized study in 20 Parkinsons disease participants at Rush University Medical Center RUMC under the supervision of Drs Hall and Keshavarzian The trial will include 10 PD patients who are de novo not yet on medication or moderate stage on medications Participants will take the prebiotics in a form of a bar Table 1 for 10 days- one bar 10 gram fiber a day for 3 days and then one bar twice a day for additional one week
Each participant will have a baseline visit and a follow up visit after 10 days of the intervention consumption of prebiotic dietary bar At each visit participants will complete questionnaires regarding adverse events including a questionnaire that rates bowel movement stool consistency discomfort flatulence abdominal pain and bloating on a scale from 1 best to 10 worst Participants will also complete a Perceived Stress Questionnaire Appendix D and GI Symptom and Severity Checklist Appendix A Participants will be asked to fill out a diet record 24ASA diet questionnaire Appendix E during the last 3 days on the intervention Participant will also are asked to self-collect stool at home before consuming eating the first probiotic bar in the study and during the last day of the study at home Supplies for stool collection 2 stool collection kit and instructions for specimen handling and for completing these tasks will be given at Visit 1 and refreshed before visit 2 At visit 1 participants will be provided with 2 stool collection kits First stool will be collected at home about 1 day and participants are asked to mail the stool in a pre-paid Fed Ex right after collecting the stool The second stool collection will be on the last day that participants consume the probiotic bars prior to coming to for study visit 2 when the participants bring the stool to the study visit The kit includes supplies to preserve the sample with gas packs and collection bag so the sample can be brought with the participant to the visits within 24 hours The self-collected stool samples will be saved by the study team and frozen for future use Participants will be asked to complete several dietary questionnaires including a Mediterranean diet screener Appendix F food timing screener Appendix B and food frequency questionnaire Appendix C Before Visit 2 each participant will collect the stool and complete the 3-day food record these will be returned at Visit 2 At Visit 2 participants will complete a Perceived Stress Questionnaire Appendix D and GI Symptom and Severity Checklist and associated instructions Appendix A Each participant will also have blood draw 1 red top to collect serum and 1 EDTA tube to collect plasma at visit 1 baseline and at visit 2 completion of the study to check for serum short chain fatty acids lipopolysaccharides interleukins and cytosine monophosphatecheck for safety
Participants will provide written informed consent Visit 1 before any study procedures data or sample collection are performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None