NCT07766733CompletedNot Applicable
An Open-Label Pilot Study to Determine Safety and Efficacy of Good Feeling Power® (a Dietary Supplement) in Patients With Either Ulcerative Colitis or Colonic/Ileal Crohn's Disease
Good Feeling Products GmbH1 site in 1 country36 target enrollmentStarted: November 6, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The effect of Good Feeling Power® on gastrointestinal symptoms, biochemical biomarkers and endoscopic parameters
Study Overview
Brief Summary
This open-label pilot study aims to evaluate the safety and efficacy of the dietary supplement Good Feeling Power® for patients with mild-to-moderate ulcerative colitis and colonic/ileal Crohn's disease.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 - 64
- •BMI 18.5 - 32.0 kg/m²
- •Mild-to-moderate UC or colonic/ileal CD
- •At least one prior episode of active disease
Exclusion Criteria
- •Extensive colonic resection or subtotal or total colectomy
- •Currently required or anticipated surgical intervention during the study
- •Any prior exposure to natalizumab, efalizumab, or rituximab
- •History or evidence of colonic mucosal dysplasia
- •Female patients who are lactating or have a positive pregnancy test
- •Any unstable or uncontrolled medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety.
Arms & Interventions
The dietary supplement Good Feeling Power® was administered to all enrolled patients.
Experimental
Intervention: Good Feeling Power® (Dietary Supplement)
Outcomes
Primary Outcomes
The effect of Good Feeling Power® on gastrointestinal symptoms, biochemical biomarkers and endoscopic parameters
Time Frame: From baseline to Day180
The primary outcomes are the changes in gastrointestinal symptoms (Simple Clinical Colitis Activity Index for ulcerative colitis (UC) patients and the Harvey-Bradshaw Index for Crohn's disease (CD) patients), biochemical biomarkers in feces (calprotectin, immunoglobulin A, hemoglobin), and endoscopic parameters (Mayo Endoscopic Score).
Secondary Outcomes
- Safety of Good Feeling Power® for patients with mild-to-moderate UC or CD(From baseline to Day180)
Investigators
Study Sites (1)
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