Trial · NCT07914387
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fecal Inflammatory Protein Quantification | Baseline (Day 0), end of fiber supplementation (Month 3 or 90 days, whichever is first), and end of 1-month washout (Month 4 or 120 days, whichever is first) | Fecal inflammatory proteins will be quantified with a multiplex immunoassay of 250 cytokines, chemokines, and other inflammation-related proteins. The primary analyses are the 1) protein level change from baseline to Month 3, 2) protein level change after a one month wash out at month 4 in a pre-specified set of key proteins (eg., TNF and IL-6). Levels will be compared between people with Parkinson's disease and cohabitating controls. |
| Primary | Bristol Stool Form Scale (BSFS) score | Weekly from baseline through Month 4 (Weeks 1-17). | Participants will complete a weekly bowel regimen questionnaire that includes the Bristol Stool Form Scale (BSFS), a validated 7-point scale of stool consistency (types 1-2 indicate constipation, 3-5 normal stool, and 6-7 diarrhea). Participants take one 11 g prebiotic fiber bar daily for 3 months, followed by a 1-month washout. The primary analysis is the rate of change in weekly BSFS score after starting supplementation (Weeks 1-12) and after stopping it (Weeks 13-17). Changes are compared between people with Parkinson's disease and cohabitating controls. Defecation frequency and other bowel symptoms from the same questionnaire are reported as separate secondary outcomes. Increase in BSFS score = decrease in constipation symptom report. |
| Secondary | Change in weekly defecation frequency during fiber supplementation and washout | Weekly from baseline through Month 4 (Weeks 1-17); supplementation phase ends at Day 90 or 3 months, whichever is first. | Self-reported number of bowel movements per week from the weekly bowel regimen questionnaire. Rate of change is evaluated during supplementation and during the 1-month washout and compared between people with Parkinson's disease and cohabitating controls. |
| Secondary | Change in Patient Assessment of Constipation Symptoms (PAC-SYM) score across fiber supplementation and washout | Weekly from baseline through Month 4 (Weeks 1-17); supplementation phase ends at Day 90 or 3 months, whichever is first. | The PAC-SYM is a validated 12-item self-report questionnaire with abdominal, rectal, and stool symptom subsections. Total scores are collected at baseline and weekly through Month 4 (Weeks 1-17). Changes from baseline to end of supplementation and from end of supplementation to end of washout are compared between people with Parkinson's disease and cohabitating controls. Higher total score indicates worse symptoms. A negative change from baseline = less constipation-related burden, positive change = more constipation-related burden. |
| Secondary | Change in Patient Assessment of Constipation Quality of Life (PAC-QoL) score | Weekly from baseline through Month 4 (Weeks 1-17); supplementation phase ends at Day 90 or 3 months, whichever is first. | AC-QoL total scores will be assessed at baseline and weekly through Month 4 (Weeks 1-17). A negative change from baseline = less constipation-related burden, positive change = more constipation-related burden. |
| Secondary | Change in gut microbiome composition and function across fiber supplementation and washout | Baseline (Day 0), end of fiber supplementation (Day 90 or 3 months, whichever is first), and end of 1-month washout (Day 120 or 4 months, whichever comes first). | DNA extracted from stool will undergo shotgun metagenomic sequencing. Gut microbe composition (ie., total abundance) will be assessed. Changes from baseline to end of supplementation and from end of supplementation to end of the 1-month washout are compared between people with Parkinson's disease and cohabitating controls. Increase in complexity (different types of gut microbiota) = generally healthier outcome. |
| Secondary | Change in fecal metabolite profile (metabolomics) across fiber supplementation and washout | Baseline (Day 0), end of fiber supplementation (Day 90 or 3 months, whichever is first), and end of 1-month washout (Day 120 or 4 months, whichever comes first). | Stool metabolites will be profiled using mass spectrometry, including microbial metabolites such as short chain fatty acids. Changes in individual metabolite abundance and pathway-level profiles from baseline to end of supplementation and from end of supplementation to end of the 1-month washout are compared between people with Parkinson's disease and cohabitating controls. Multiple-comparison correction will be applied. |
| Secondary | Change in autonomic symptoms (SCOPA-AUT total and gastrointestinal subscale score) across fiber supplementation and washout | Baseline (Day 0), end of fiber supplementation (Day 90 or 3 months, whichever is first), and end of 1-month washout (Month 4) | The SCOPA-AUT is a validated self-report questionnaire of autonomic symptoms over the past month, with gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillomotor, and sexual domains. Each item is scored 0 (never) to 3 (often). Total score (0-69) and gastrointestinal subscale score (0-21) are collected at baseline, at the end of supplementation, and at the end of the 1-month washout. Changes from baseline to end of supplementation and from end of supplementation to end of washout only by participants with Parkinson's disease. Higher scores indicate worse autonomic symptoms. A negative change from baseline = less burden, positive change = more burden. |
| Secondary | Change in participant-reported non-motor experiences of daily living (MDS-UPDRS Part IB) in people with Parkinson's disease across fiber supplementation and washout | Baseline (Day 0), end of fiber supplementation (Day 90 or 3 months, whichever is first), and end of 1-month washout (Month 4). | MDS-UPDRS Part IB is a validated 7-item questionnaire covering non-motor symptoms over the past week, including constipation, urinary problems, lightheadedness on standing, fatigue, sleep problems, daytime sleepiness, and pain. Each item is scored 0 (normal) to 4 (severe), for a total of 0-28. Completed only by participants with Parkinson's disease. Total score and the constipation item are compared within participants from baseline to the end of supplementation and from the end of supplementation to the end of the 1-month washout. Higher scores indicate worse symptoms. Higher score = increased burden. |
| Secondary | Change in participant-reported motor experiences of daily living (MDS-UPDRS Part II) in people with Parkinson's disease across fiber supplementation and washout | Baseline (Day 0), end of fiber supplementation (Day 90 or 3 months, whichever is first), and end of 1-month washout (Month 4). | MDS-UPDRS Part II is a validated 13-item participant questionnaire on the impact of motor symptoms on daily activities over the past week (for example speech, eating, dressing, hygiene, walking, tremor). Each item is scored 0 (normal) to 4 (severe), for a total of 0-52. Completed only by participants with Parkinson's disease. Total scores are compared within participants from baseline to the end of supplementation and from the end of supplementation to the end of the 1-month washout. Higher scores indicate greater motor disability. A negative change from baseline = less burden, positive change = more burden. |
| Other | Association of baseline Parkinson's disease risk factors (PD-RFQ) with fecal inflammatory protein, microbiome, and metabolite response to fiber supplementation | Baseline (Day 0) for PD-RFQ; Month 4 for confirmation of address and employment | Participants will complete the Parkinson's Disease Risk Factor Questionnaire (PD-RFQ) at baseline to capture environmental, lifestyle, and medication exposures. At Month 4, participants will confirm whether their residential address or employment has changed since baseline, to verify that exposures were stable during the study. Exploratory analyses will test whether baseline risk factors are associated with changes in fecal inflammatory proteins, gut microbiome composition, and fecal metabolites from baseline to the end of supplementation and through the 1-month washout. Participants with a change in address or employment will be flagged and examined in sensitivity analyses. Higher score = higher estimated PD risk. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07914387/registered