An interventional study of Microencapsulated sodium propiolate and Microencapsulated sodium Butyrate in Crohn Disease, sponsored by University of Padova. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of Padova · Not applicable, Interventional, and Treatment
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:
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:
This randomized, double-blind, crossover pilot clinical trial is designed to investigate the effects of microencapsulated sodium propionate on gut microbiota modulation in patients with inflammatory bowel disease (IBD), and to compare these effects with those of sodium butyrate.
Short-chain fatty acids (SCFAs), including butyrate and propionate, are key metabolites produced by intestinal microbiota through the fermentation of dietary fibers. While butyrate has been widely studied and applied in clinical settings, propionate remains less explored despite evidence suggesting its role in regulating intestinal motility, immune responses, and metabolic pathways. The development of a microencapsulated formulation of sodium propionate enables targeted delivery to the colon, potentially enhancing its therapeutic efficacy.
The study will enroll adult patients with Crohn's disease in remission or with mild disease activity. Participants will be randomly assigned to receive either microencapsulated sodium butyrate or sodium propionate for a defined treatment period, followed by a washout phase and subsequent crossover to the alternate treatment. This design allows each participant to serve as their own control, improving the ability to detect treatment-related differences.
The primary focus of the study is to characterize changes in gut microbiota composition and function using advanced shotgun metagenomic sequencing, with particular attention to microbial diversity and metabolic pathways. In parallel, the study will explore the immunomodulatory effects of propionate by assessing inflammatory cytokines and pathways associated with immune regulation.
Additionally, the study will examine the broader clinical impact of treatment through patient-reported outcomes related to quality of life. By integrating microbiological, immunological, and clinical data, this study aims to clarify the therapeutic potential of propionate and expand current knowledge on SCFA-based interventions in IBD management.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of Padova is the lead sponsor of 214 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
\*\*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.
Dietary Supplement: Microencapsulated sodium propiolate
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.
Dietary Supplement: Microencapsulated sodium Butyrate
Sodium propionate is administered as a microencapsulated oral formulation designed to ensure targeted delivery to the colon. This delivery system aims to enhance local availability of the compound and optimize its interaction with the intestinal microbiota.
Also known as: Sopronil
Sodium butyrate is administered as a microencapsulated oral formulation designed to allow targeted release in the colon. This delivery approach is intended to maximize its local effects on the intestinal microbiota and mucosal environment.
Also known as: Butyrose
Change in Gut Microbiota Composition
Assessment of changes in gut microbiota composition and diversity,
Time frame: At baseline; at the first 45-day treatment period, and at the end of the second 45-day treatment period following crossover and washout (up to 15 weeks).
Change in metabolic pathway
Shotgun metagenomic analysis of fecal samples collected at predefined time points.
Time frame: At baseline; at the first 45-day treatment period, and at the end of the second 45-day treatment period following crossover and washout (up to 15 weeks).
Changes in Inflammatory Markers
Evaluation of the effects of sodium propionate compared to sodium butyrate on inflammatory cytokines (IL-17, IFN-γ, IL-10),
Time frame: At baseline, after the first 45-day treatment period, and at the end of the second 45-day treatment period following crossover and washout (up to 15 weeks).
Changes in Immune Cell Modulation
Evaluation of the effects of sodium propionate compared to sodium butyrate on immune regulation through modulation of Treg and Th17 cell activity,
Time frame: At baseline, after the first 45-day treatment period, and at the end of the second 45-day treatment period following crossover and washout (up to 15 weeks).
Changes in Quality of Life
Evaluation of the effects of sodium propionate compared to sodium butyrate on patient-reported quality of life measured by the IBDQ questionnaire at predefined time points ( score 32-224, \>170 good QoL)
Time frame: At baseline, after the first 45-day treatment period, and at the end of the second 45-day treatment period following crossover and washout (up to 15 weeks).
Plan to share: Yes — Only data generated within the study will be shared among the research team, including: Fecal microbiota data obtained from shotgun metagenomic analysis Blood sample data related to inflammatory cytokines (e.g., IL-17, IFN-γ, IL-10) Patient-reported outcomes from quality-of-life questionnaires (IBDQ) All data will be handled in a **pseudonymized form** and will be accessible exclusively to the investigators involved in the study for research purposes.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The data will be available at the end of enrollment and only for the time necessary for bioinformatic and statistical analysis (2 months). At the end, anonymized data will be made available in dedicated databases for researchers who submit a formal request.
Access criteria: The repository where the data will be deposited has not yet been determined.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Nov 2028, 25 months after the start.
Of 280 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 67. This study's planned 25 months is below that.
Counting every sponsor, half of 289 studies reached it within 45 months; a quarter within 22 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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