Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03667404|
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Intestinal Bacteria Flora Disturbance Dietary Modification||Dietary Supplement: Resistant maltodextrin Dietary Supplement: maltodextrin||Phase 2|
Intestinal microbiota may play in important role in Parkinson's disease (PD). Colonic bacteria play roles in multiple functions including gut motility and secretion of metabolites which can have systemic effects on the body. Recent evidence has shown that people with PD have an altered distribution of gut bacteria that healthy controls. These changes are associated with differences in various metabolites, including butyrate, that are involved in maintaining the gut barrier integrity and even gait and balance function. Microbiota dysbiosis could potentially exacerbate or even contribute to the pathogenesis of PD. Probiotic and dietary interventions may improve gut function and the motor symptoms in PD, but neither have been examined for their effect on the gut microbiome. Prebiotic treatments have been shown to order the microbiome in some populations, but have not been assessed for tolerability or efficacy in PD.
The objective of this study is to examine the safety and tolerability of resistant maltodextrin (RM), a prebiotic non-digestible fiber, and its effect on the microbiome and motor in non-motor symptoms and PD. The investigators will conduct a randomized, parallel-group double-blinded controlled trial assessing RM 50 g daily compared to maltodextrin (an easily digestible glucose polysaccharide) over 4 weeks. Patients will be dosed with 25 g daily for 1 week and then titrated to 50 g daily for the remaining 3 weeks.
The goals of this study include: 1) To determine the safety and tolerability of RM compared to maltodextrin in patients with PD; 2) To determine if RM will remodel the gut microbiome in patients with PD; 3) (exploratory) To determine if RM administration will improve motor and non-motor symptoms in PD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind placebo (maltodextrin) controlled randomized trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
participants will be blinded to condition. control condition (maltodextrin) will be used and has identical appearance.
investigator and research staff (except pharmacy) will be blinded to condition
|Official Title:||Gut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability Study|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Resistant Maltodextrin
Resistant maltodextrin (RM) powder 25 g during days 1-7 and 50g during days 8-28, each dose dissolved in 8 oz of water once daily in the morning.
Dietary Supplement: Resistant maltodextrin
Resistant maltodextrin powder
Placebo Comparator: Maltodextrin
Maltodextrin 25g for days 1-7 and 50 g for days 8-28, each dose dissolved in 8 oz of water once daily in the morning.
Dietary Supplement: maltodextrin
- Adverse events [ Time Frame: 4 weeks ]Adverse event frequency and severity based on diary reports, phone calls, and in-person assessments.
- Gut microbial remodeling [ Time Frame: 4 weeks ]Change in fecal butyrate-producing bacteria based on high-throughput amplicon sequencing of the V4 variable region of the microbial 16s ribosomal ribonucleic acid (RNA) gene.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667404
|Contact: Francesca Moroniemail@example.com|
|Contact: Roneil Malkani||(312) firstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Northwestern G University 312-503-1530|
|Contact: James Sbarboro (312) 503-1948 email@example.com|
|Principal Investigator:||Roneil G Malkani||Northwestern Feinberg School of Medicine Department of Neurology|