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PARKINSON DISEASE (Disorder)NCT07127120

Open Label Single Arm Prebiotic Pilot Trial SR001

A study testing Prebiotic fiber blend in people with PARKINSON DISEASE (Disorder), run by Sorridi Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
PARKINSON DISEASE (Disorder)
What is being tested?
Prebiotic fiber blend
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Jul 2024to 15 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sorridi Therapeutics

    Northbrook, Illinois, 60062

Other trials in United States

About this study

Official title: A Single Arm, Open Label Study to Assess the Tolerability of a Prebiotic in Adults With Parkinson's Disease and Healthy Adults

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.

Read the detailed description

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.

Being tested
Prebiotic fiber blend
Keywords
Parkinsons, Fiber, prebiotic, inflammation, constipation
Medical subject headings
Parkinson Disease, Inflammation, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07127120
Study groupRoleWhat they receive
Prebiotic Fiber BarExperimentalOpen-label consumption of prebiotic fiber bars 1 bar/day for 4 weeks
Receives: Dietary Supplement: Prebiotic fiber blend

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to 4 weeks on intervention

  2. 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.

    Measured: 4 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 4 weeks

  2. 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.

    Measured: 4 weeks

  3. 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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start1 Jul 2024
  3. Primary completion1 Jul 2025
  4. Study completion15 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07127120
Sponsor's protocol ID
SR001
Other IDs
1376682
Status last verified
Apr 2026
First submitted
8 Aug 2025
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic fiber blend in people with PARKINSON DISEASE (Disorder), run by Sorridi Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability of Prebiotic Fiber bar in Parkinson's Patients (time frame: From enrollment to 4 weeks on intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07127120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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