NCT07447154

GenesiDol for the Management of Musculoskeletal Pain

GenesiDol for the Management of Musculoskeletal Pain in Patients With Inflammatory Bowel Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic, relapsing conditions characterized by persistent inflammation of the gastrointestinal tract and a significant impact on patients' quality of life. Crohn's disease can involve any part of the gastrointestinal tract, most commonly the terminal ileum and colon, whereas ulcerative colitis is confined to the colonic mucosa. Typical symptoms include abdominal pain, diarrhea, fatigue, fever, and weight loss, often alternating between periods of remission and disease flare-ups.In addition to intestinal involvement, IBD are frequently associated with extraintestinal manifestations affecting multiple organ systems. Among these, enteropathic arthritis represents one of the most common and clinically relevant complications. It belongs to the spectrum of spondyloarthritis, a group of inflammatory joint disorders characterized by axial and/or peripheral involvement, enthesitis, and dactylitis. Enteropathic arthritis is reported in a substantial proportion of IBD patients and may occur independently of intestinal disease activity. Although its pathogenesis is not fully understood, current evidence suggests a multifactorial mechanism involving gut microbiota dysbiosis, immune dysregulation with expansion of Th17 cells, and migration of activated immune cells to the joints in genetically predisposed individuals.Management of musculoskeletal manifestations in IBD remains challenging. Conventional therapeutic strategies are primarily aimed at controlling intestinal inflammation and often fail to adequately address joint pain. Escalation of immunomodulatory or biologic therapies may be required when articular symptoms parallel intestinal flares; however, persistent pain can occur even during disease remission, potentially due to nociplastic or neuropathic mechanisms or degenerative joint disease. The long-term use of analgesic and anti-inflammatory medications, including COX-2 inhibitors, antidepressants, anticonvulsants, opioids, and cannabis, is associated with relevant adverse effects and may worsen gastrointestinal symptoms.Given these limitations, non-pharmacological and complementary approaches are gaining interest. Nutraceutical interventions have shown promising results in alleviating musculoskeletal symptoms while minimizing gastrointestinal toxicity. GenesiDol, a nutrigenomic dietary supplement containing palmitoylethanolamide, avocado/soy extracts, probiotics, antioxidants, and neuroprotective compounds, represents a potential supportive strategy for the management of chronic musculoskeletal pain in patients with IBD.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	Genesidol	administration of the supplement to patients with chronic inflammatory bowel diseases

Timeline

• Start date: 2026-02-26
• Primary completion: 2026-07-15
• Completion: 2027-01-15
• First posted: 2026-03-03
• Last updated: 2026-03-03