Genesidol
administration of the supplement to patients with chronic inflammatory bowel diseases
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-03-03
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Interventions
administration of the supplement to patients with chronic inflammatory bowel diseases
Eligibility
primary outcomes
Time frame: Baseline to 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).
secondary outcomes
Time frame: Up to 1 year
Anxiety assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Psychological profile - anxiety will be assessed using the Hospital Anxiety and Depression Scale - Anxiety Subscale, a 7-item questionnaire with a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity (worse outcome).
Time frame: Up to 1 year
Depression assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D).Psychological profile - depression will be assessed using the Hospital Anxiety and Depression Scale - Depression Subscale, a 7-item questionnaire with a total score ranging from 0 to 21. Higher scores indicate greater depression severity (worse outcome).
Time frame: Up to 1 year
Perceived stress assessed by the Perceived Stress Scale (PSS-10). Psychological profile - stress will be assessed using the Perceived Stress Scale (10-item version), with total scores ranging from 0 to 40. Higher scores indicate higher perceived stress (worse outcome).
Time frame: Up to 1 year
Pain coping strategies assessed by the Coping Strategies Questionnaire (CSQ). Psychological profile - pain coping strategies will be assessed using the Coping Strategies Questionnaire, with subscale scores varying depending on the coping domain. Higher scores indicate greater use of the specific coping strategy; interpretation (adaptive vs maladaptive) depends on the subscale.
Time frame: Up to 1 year
Gut microbiota alpha diversity will be assessed from fecal samples using the Shannon Diversity Index, a quantitative measure of within-sample microbial diversity. The index has no fixed upper limit; higher values indicate greater microbial diversity (generally considered a more favorable outcome).
Time frame: Up to 1 year
Between-sample microbial diversity will be assessed using the Bray-Curtis dissimilarity index, which ranges from 0 to 1. Higher values indicate greater dissimilarity in microbial composition between samples.
Time frame: Up to 1 year
Relative abundance of pre-specified bacterial taxa will be assessed from fecal samples and expressed as percentage (%) of total bacterial sequences. Values range from 0% to 100%. Higher percentages indicate greater relative abundance of the specific taxon analyzed.
Time frame: Up to 1 year
Intestinal response to therapy in participants with Crohn's disease will be assessed using the Crohn's Disease Activity Index (CDAI). The CDAI score typically ranges from 0 to approximately 600, with higher scores indicating more severe disease activity (worse outcome). Clinical response will be defined according to established criteria (e.g., reduction of ≥100 points from baseline), and remission as CDAI \<150.
Time frame: Up to 1 year
Intestinal response to therapy in participants with ulcerative colitis will be assessed using the Mayo Score, which ranges from 0 to 12. Higher scores indicate more severe disease activity (worse outcome). Clinical response and remission will be defined according to established criteria (e.g., total score ≤2 with no individual subscore \>1 for remission).
Time frame: Baseline to 12 weeks after completion of supplementation
Change from baseline in perceived musculoskeletal pain intensity measured using the Visual Analog Scale (VAS), a 100-mm visual analog scale ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome). Assessments will be performed at baseline and 12 weeks after completion of the GenesiDol dietary supplementation protocol in adult patients with inflammatory bowel disease (IBD).
Time frame: Baseline to 12 weeks after completion of supplementation
Change from baseline in serum zonulin levels measured in ng/mL in adult patients with inflammatory bowel disease (IBD). There is no universally established fixed minimum or maximum value; typical reference values in serum are approximately 34 ng/mL in healthy individuals. Higher levels are generally interpreted as reflecting increased intestinal permeability (worse outcome).
Time frame: Baseline to 20 weeks
Change from baseline in perceived musculoskeletal pain intensity in the control group (participants who did not receive the dietary supplementation protocol), measured using the Visual Analog Scale (VAS), a 100-mm visual analog scale ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).
Time frame: Baseline to up to 1 year
Anxiety will be assessed using the Hospital Anxiety and Depression Scale - Anxiety Subscale, a 7-item questionnaire with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity (worse outcome).
Time frame: Baseline to up to 1 year
Depression will be assessed using the Hospital Anxiety and Depression Scale - Depression Subscale, a 7-item questionnaire with total scores ranging from 0 to 21. Higher scores indicate greater depression severity (worse outcome).
Time frame: Baseline to up to 1 year
Perceived stress will be assessed using the Perceived Stress Scale (10-item version), with total scores ranging from 0 to 40. Higher scores indicate higher perceived stress levels (worse outcome).
Time frame: Baseline to up to 1 year
Pain coping strategies will be assessed using the Coping Strategies Questionnaire, which includes multiple subscales. Subscale scores vary depending on the coping domain assessed. Higher scores indicate greater use of the specific coping strategy; interpretation as adaptive or maladaptive depends on the subscale.
Time frame: Baseline to up to 1 year
Change from baseline in psychological status assessed using validated questionnaires measuring anxiety, depression, stress, and pain-related psychological factors in adult patients with inflammatory bowel disease.
Time frame: Baseline to up to 1 year
Change from baseline in nutritional status assessed using anthropometric measures and nutritional assessment tools (e.g., body mass index, body composition, dietary assessment) in adult patients with inflammatory bowel disease.
Time frame: Baseline to up to 1 year
Change from baseline in gut microbiota composition assessed by stool sample analysis, including microbial diversity indices and relative abundance of bacterial taxa, in adult patients with inflammatory bowel disease.
Time frame: Baseline to up to 1 year
Change from baseline in metabolomic profile assessed by analysis of biological samples using validated metabolomic techniques in adult patients with inflammatory bowel disease.
Time frame: Baseline to up to 1 year
Change from baseline in serum lipopolysaccharide (LPS) levels, measured as a biomarker of intestinal permeability, to assess the effect of GenesiDol on epithelial barrier function.
Time frame: Baseline to up to 1 year
Change from baseline in serum zonulin levels, measured as a biomarker of intestinal epithelial barrier function, to assess the effect of GenesiDol on intestinal permeability.
Time frame: Up to 1 year
Adherence to the study product regimen will be measured using weekly patient diaries in which participants record daily intake of the study product. Data will be collected for both the active treatment group and the placebo group, and adherence will be summarized as the proportion of prescribed doses taken over the study period.
Publications
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