GenesiDol for the Management of Musculoskeletal Pain

NCT07447154 | Not Yet Recruiting

• 1 other identifier: ID: 8300
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in musculoskeletal pain intensity measured by Visual Analog Scale (VAS) at 8 weeks

  Change from baseline in perceived musculoskeletal pain intensity, measured using the Visual Analog Scale (VAS), a 100-mm visual analog scale with a minimum score of 0 mm (no pain) and a maximum score of 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).

  Baseline to 8 weeks

Secondary Outcomes (23)

• Psychological profile assessed by validated psychological questionnaires in adult IBD patients with musculoskeletal pain

  Up to 1 year

• Psychological profile assessed by validated psychological questionnaires in adult IBD patients with musculoskeletal pain

  Up to 1 year

• Psychological profile assessed by validated psychological questionnaires in adult IBD patients with musculoskeletal pain

  Up to 1 year

• Psychological profile assessed by validated psychological questionnaires in adult IBD patients with musculoskeletal pain

  Up to 1 year

• 1. Gut microbiota alpha diversity assessed by Shannon Diversity Index

  Up to 1 year

Study Arms (2)

gensidol

EXPERIMENTAL

administration of the supplement to patients with chronic inflammatory bowel diseases

Other: Genesidol

placebo

PLACEBO COMPARATOR

administration of the placebo to patients with chronic inflammatory bowel diseases

Other: Genesidol

Interventions

Genesidol OTHER

administration of the supplement to patients with chronic inflammatory bowel diseases

gensidol; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 65 years.
• Patients diagnosed with IBD for at least six months.
• Ability to understand and provide signed informed consent.
• Patients with IBD and a prior diagnosis of axial/peripheral spondyloarthritis without objec-tive evidence of joint inflammation (clinical and/or instrumental, as per rheumatological as-sessment), but with persistent musculoskeletal pain (VAS scale score \>50/100 in the last week; HAQ-DI score \>0.5; FACIT Fatigue Scale score ≥40; NPS score \>1) Or
• Patients with IBD and musculoskeletal pain who do not meet the criteria for the diagnosis of spondyloarthritis or other inflammatory arthritis (as per rheumatological assessment), but with persistent musculoskeletal pain (VAS scale score \>5/10 in the last week; HAQ-DI score \>0.5; FACIT Fatigue Scale score ≥40; NPS score \>1).

You may not qualify if:

• Patients under 18 or over 65 years of age.
• Patients affected by Inflammatory Bowel Disease-Unclassified (IBD-U).
• Inability to provide informed consent.
• Refusal to provide informed consent.
• Presence of severe language deficits.
• Patients diagnosed with axial/peripheral spondyloarthritis with objective evidence of joint inflammation (clinical and/or instrumental, as per rheumatological assessment).
• Patients with other comorbidities that may invalidate rheumatological evaluation (Substance Use Disorder, Schizophrenia Spectrum and other Psychotic Disorders, Diabetes Mellitus, other rheumatological diseases).
• Patients on anticoagulant and/or antiepileptic therapy.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Franco Scaldaferri

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Scaldaferri

CONTACT

+390630156265; franco.scaldaferri@policlinicogemelli.it

Francesca Profeta

CONTACT

+390630157104; francesca.profeta@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: March 3, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: March 3, 2026

Record last verified: 2025-12