Crohn DiseasePSM_IBDNCT07883044
Microencapsulated Sodium Propionate in IBD Microbiota Modulation
A study testing Microencapsulated sodium propiolate and Microencapsulated sodium Butyrate in people with Crohn Disease, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Microencapsulated sodium propiolate and Microencapsulated sodium Butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2026to 30 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe disease activity and ulcerative colites diagnosis
- Positive stool test for Clostridioides difficile
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Microencapsulated Sodium Propionate: a Potential Ally in Microbiota Modulation for the Treatment of Chronic Inflammatory Bowel Diseases
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Crohn Disease
- Being tested
- Microencapsulated sodium propiolate, Microencapsulated sodium Butyrate
- Keywords
- Microbiota, T cells
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microencapsulated sodium propiolateDietary supplement
Also called Sopronil
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.
Microencapsulated sodium ButyrateDietary supplement
Also called Butyrose
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.
| Study group | Role | What they receive |
|---|---|---|
| Microencapsulated sodium propionate | Experimental | 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. Receives: Dietary Supplement: Microencapsulated sodium propiolate |
| Microencapsulated sodium butyrate | Active comparator | 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. Receives: Dietary Supplement: Microencapsulated sodium Butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Microbiota Composition
Assessment of changes in gut microbiota composition and diversity,
Measured: 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).
Secondary outcomes (4)
Change in metabolic pathway
Shotgun metagenomic analysis of fecal samples collected at predefined time points.
Measured: 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),
Measured: 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,
Measured: 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)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Oct 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized, double-blind, crossover clinical trial with two treatment arms. Participants are randomly assigned to receive either microencapsulated sodium propionate or sodium butyrate for an initial treatment period, followed by a washout phase and subsequent crossover to the alternate treatment. The crossover design allows each participant to serve as their own control, improving the comparison between interventions and reducing inter-individual variability. Both participants and investigators are blinded to treatment allocation to minimize bias. The study follows a longitudinal framework with repeated measurements collected at baseline, after the first treatment period, and after the second treatment period. Biological samples and clinical data are collected at each time point to assess changes over time within and between treatments.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savarino Edoardo Vincenzo, University of Padova
- Investigators
- Edoardo Savarino, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883044
- Sponsor's protocol ID
- AOPD4094
- Acronym
- PSM_IBD
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microencapsulated Sodium Propionate: a Potential Ally in Microbiota Modulation for the Treatment of Chronic Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT07883044
- Acronym / sponsor ID
- PSM_IBD / AOPD4094
- Conditions
- Crohn Disease
- Keywords
- Microbiota, T cells
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study is a randomized, double-blind, crossover clinical trial with two treatment arms. Participants are randomly assigned to receive either microencapsulated sodium propionate or sodium butyrate for an initial treatment period, followed by a washout phase and subsequent crossover to the alternate treatment. The crossover design allows each participant to serve as their own control, improving the comparison between interventions and reducing inter-individual variability. Both participants and investigators are blinded to treatment allocation to minimize bias. The study follows a longitudinal framework with repeated measurements collected at baseline, after the first treatment period, and after the second treatment period. Biological samples and clinical data are collected at each time point to assess changes over time within and between treatments.
| Arm | Type | Receives |
|---|---|---|
| Microencapsulated sodium propionate | Experimental | Dietary Supplement: Microencapsulated sodium propiolateExperimental 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. |
| Microencapsulated sodium butyrate | Active comparator | Dietary Supplement: Microencapsulated sodium ButyrateParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Severe disease activity and ulcerative colites diagnosis
- Positive stool test for Clostridioides difficile
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microencapsulated sodium propiolateAlso: SopronilSodium 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. | Dietary supplement | Microencapsulated sodium propionate |
| Microencapsulated sodium ButyrateAlso: ButyroseSodium 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. | Dietary supplement | Microencapsulated sodium butyrate |
Primary outcome
Change in Gut Microbiota Composition
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).
Assessment of changes in gut microbiota composition and diversity,
4 secondary outcomes
Change in metabolic pathway
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
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
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edoardo Savarino principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microencapsulated sodium propiolate and Microencapsulated sodium Butyrate in people with Crohn Disease, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edoardo Savarino (+39 049 8217744, edoardo.savarino@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbiota Composition (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.