Crohn's Disease Clinical Trials

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Microencapsulated Sodium Propionate: a Potential Ally in Microbiota Modulation for the Treatment of Chronic Inflammatory Bowel Diseases

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate whether microencapsulated sodium propionate can modulate the gut microbiota and improve inflammatory and immunological parameters in adult patients with inflammatory bowel disease (IBD) in remission or with mild disease activity. The study will also compare its effects with those of sodium butyrate. The main questions it aims to answer are: * Does sodium propionate modify gut microbiota composition and metabolic pathways in patients with IBD? * Does sodium propionate influence inflammatory markers, immune cell balance (Treg/Th17), and quality of life? Researchers will compare sodium propionate to sodium butyrate to determine whether propionate provides similar or additional benefits in microbiota modulation and inflammation control. Participants will: * Take either microencapsulated sodium propionate or sodium butyrate daily for 45 days, followed by a washout period and crossover to the alternate treatment * Provide stool samples for microbiota analysis and blood samples for inflammatory cytokine assessment at predefined time points * Complete quality-of-life questionnaires (IBDQ) during the study period

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Confirmed diagnosis of Crohn's disease based on clinical, endoscopic, and histopathological evidence (colonoscopy performed within 2 months prior to enrollment)

• Disease in remission or with mild clinical activity (Mayo score 0-1), confirmed by clinical, endoscopic, or histopathological findings

• Age between 18 and 75 years

• Ability to fully participate in all aspects of the clinical study

Locations
Other Locations
Italy
Edoardo V. Savarino
RECRUITING
Padova
Contact Information
Primary
Edoardo Savarino
edoardo.savarino@unipd.it
+39 049 8217744
Backup
Sonia Facchin
sonia.facchin@unipd.it
+39 040 821 8720
Time Frame
Start Date: 2026-10-01
Estimated Completion Date: 2029-01-30
Participants
Target number of participants: 50
Treatments
Experimental: Microencapsulated sodium propionate
\*\*Experimental Arm: Microencapsulated Sodium Propionate\*\*~Participants assigned to the experimental arm will receive \*\*microencapsulated sodium propionate (Sopronil)\*\* administered orally in capsule form. The dosage consists of \*\*three capsules per day\*\*, corresponding to a total daily dose of \*\*710 mg of sodium propionate\*\*, for a duration of \*\*45 days\*\*.~The formulation is designed using microencapsulation technology to allow \*\*targeted release in the colon\*\*, potentially enhancing local bioavailability and interaction with the gut microbiota.
Active_comparator: Microencapsulated sodium butyrate
Participants assigned to the active comparator arm will receive \*\*microencapsulated sodium butyrate (Butyrose)\*\* administered orally in capsule form. The dosage consists of \*\*three capsules per day\*\*, corresponding to a total daily dose of \*\*600 mg of sodium butyrate\*\*, for a duration of \*\*45 days\*\*.~The formulation is designed to ensure \*\*targeted release in the colon\*\*, allowing optimal local activity on the gut microbiota and intestinal mucosa.
Related Therapeutic Areas
Sponsors
Leads: University of Padova

This content was sourced from clinicaltrials.gov