Approaches That Translate Into Better Care.
Clinical Investigation
Clinical Investigation
Approaches That Translate Into Better Care.
Introduction
Introduction
Understanding complex, overlapping conditions like IBS, IBD, functional dyspepsia, and gut-brain syndromes requires more than observation. It demands systems that track how symptoms evolve, how patients respond across domains, and how interventions affect outcomes over time.
At Penn Clinical, research is embedded into the care process itself. Every protocol is designed for outpatient settings, structured for reproducibility, and focused on producing data that translates directly into smarter treatment pathways.
A Clinic-First Approach to Research
At Penn Clinical, care and research are layered together. Patients receive evidence-based treatment while also participating in structured, scalable outcome tracking
Key elements include:
- Dietary changes tracked alongside validated GI symptom scales [1]
- Telehealth-delivered CBT evaluated using mood and cognition measures [2]
- Functional GI complaints mapped continuously—not episodically
- Symptom and outcome tracking built seamlessly into clinical follow-up
This ensures that every patient encounter contributes to new evidence—without disrupting care delivery.
Tools for Capturing Multi-System Responses
Patients rarely fit into a single category—symptoms cross GI, cognitive, neurological, and emotional systems. The tools selected here are built for that reality.
Mood, Sleep & Cognitive Measures
Cognitive Load and Neural Resilience Scoring
- Lightweight EEG-based or near-infrared devices are being piloted to measure cognitive fatigue, attention shifts, and executive function alongside GI symptom monitoring.
- Real-time cognitive scoring complements traditional assessments like the Stroop Test and MoCA, enabling more dynamic tracking of brain-gut symptom interactions.
AI Integration in Clinical Research
Penn Clinical is implementing applied AI tools into both clinical operations and research discovery.
AI-Powered Drug Repurposing (Proof-of-Concept)
By analyzing real-world patient data—outcomes, symptom patterns, microbiome signals—Penn Clinical is using AI to uncover novel uses for existing therapies, especially across gut-brain conditions like Parkinson’s and mood-GI syndromes.
Virtual Trial Optimization (Prototype Phase)
A modular AI tool predicts patient retention and engagement risk in decentralized trials, improving design strategies for outpatient studies involving diet, CBT, and neuromodulation.
These AI initiatives aim to build faster, smarter, more patient-centered research frameworks.
Longitudinal and Systems-Aware Study Design
Longitudinal and Systems-Aware Study Design
Rather than academic models built around single diseases, Penn Clinical designs research to track systems over time.
Study design characteristics:
- Outpatient-based cohorts integrated with standard care
- Remote-compatible data capture: digital diaries, validated scales, cognitive and GI monitoring
- Short- and medium-term trials (6–12 weeks; 3–6 months)
- Instruments selected for clinical usability—not research convenience
Cognitive assessments, microbiome sampling, symptom diaries, and emotional health scales are layered into care to enable longitudinal tracking across gastrointestinal, neurological, and psychiatric systems—without burdening patients.
Why This Works
Why This Works
Most research isolates one system. Most patients don’t.
Penn Clinical’s methodology reflects real-world complexity:
- GI, mood, cognition, inflammation, and microbial profiles are tracked together
- Tools are embedded into standard care—not bolted on afterward
- Data generated is clinically actionable, scalable, and AI-ready
The result is a model where systems-level insight leads directly to earlier interventions, smarter therapies, and better outcomes across specialties.
References
Whole-food diet interventions in IBS
CBT + telehealth for IBS – ClinicalTrials.gov NCT04167976
IBS-SSS validation
NDI index for dyspepsia
CDAI for Crohn’s
Gastroparesis Cardinal Symptom Index
Beck Depression Inventory (BDI)
PHQ-9 use in GI and mood screening
Hamilton Depression Scale (HDRS)
GAD-7 validation
MoCA cognitive screening
Cognitive testing in Parkinson’s GI research
PSQI and GI symptom response
Microbiome profiling in clinical GI research
13C gastric emptying test
nVNS applications in gut-brain axis
Remote monitoring and symptom tracking apps in GI care
GI symptom tracking in depression – Fond G et al.
GI symptoms in Parkinson’s – Fasano A et al.
