Irritable Bowel Syndrome With DiarrheaB/P3_1NCT06432569
Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1)
A study testing ButirBioma + PeaBioma in people with Irritable Bowel Syndrome With Diarrhea, run by University of Padova at 1 site in Italy.
Trial summary
Evaluation of the effects of butyrate ( BitirBioma) and palmitoylethanolamide( PEA=PeaBioma) on intestinal permeability and gut microbiota composition in patients with irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- ButirBioma + PeaBioma
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2024to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ● IBS patients (both males and females) with positive diagnosis based on Rome IV criteria (IBS-D and IBS-M)
- Age in the range 18-70 years
- Subjects capable of conforming to the study protocol
- Subjects who have given their free and informed consent
Who cannot join
- -Any relevant organic, systemic or metabolic disease, including celiac disease, IDDM (Insulin- Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapses, urinary incontinence, ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease.
- Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
- Prior major gastrointestinal surgeries
- Females of childbearing potential, in the absence of effective contraceptive methods
- Subjects who become unable to conform to protocol
- Subjects who are continuously taking contact laxatives
Show all 10Show fewer
- Subjects who are treated continuously with glucocorticoids, anti-histaminergic and mast cell stabilizer drugs
- Subjects who are treated continuously with trimebutine
- Recent history or suspicion of alcohol abuse or drug addiction
- Subjects who are treated with antibiotics or probiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Butyrate and Palmitoylethanolamide Effects on Intestinal Permeability and Microbiota Gut Composition in Patients With Irritable Bowel Syndrome - A Double-blind, Placebo-controlled Crossover Randomized Study
Evaluation of the effects of butyrate ( BitirBioma) and palmitoylethanolamide( PEA=PeaBioma) on intestinal permeability and gut microbiota composition in patients with irritable bowel syndrome.
Study B/P 3_1 is an interventional study involving the use of food supplements on the market (BitirBioma Plus and PeaBioma Plus), single-center, double-blind, placebo-controlled, crossover, randomized, in n=50 patients with bowel syndrome irritable, diarrheal and mixed variant (IBS-D and IBS-M), lasting for one year.
Read more
The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch).
Eligible subjects with IBS will be randomized in a 1:1 ratio to treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period.
Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design.
In the two treatment periods, subjects will be required to complete a visual analogue score VAS questionnaire to assess gastrointestinal symptoms and Stool Bristol Scales. During the visit, the subjects will have to record Questionnaire Rome IV to evaluate their quality of life. At the same time, it will be theirs required to provide:
- fecal sample for the evaluation of the composition of fecal microbiota (Biomaplan Kit)
- a urine sample for the evaluation of intestinal permeability (Gastropack) a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG )
- a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG )
Read the detailed description
Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon, characterized by relapsing and remitting mucosal inflammation. It presents with symptoms like bloody diarrhea, rectal urgency, fatigue, and abdominal pain. While various therapies are available for managing UC, including medications like amino salicylates, corticosteroids, immunomodulators, and biologics, there's ongoing research into supportive treatments like probiotics.
Probiotics are beneficial microorganisms that can positively influence gut health by modifying the gut microbiota, improving intestinal barrier function, and balancing immune response. Several studies have investigated their efficacy in UC management. Notably, the probiotic mixture VSL#3, containing strains of Lactobacillus and Bifidobacteria, has shown promising results in inducing remission in UC patients.
Other probiotic products like E. coli Nissle 1917, L. rhamnosus GG, and L. casei DG have also demonstrated effectiveness in maintaining disease remission or prolonging relapse-free periods in UC patients. The product Prolife 10 FORTE, containing multiple strains of Lactobacillus, Bifidobacteria, and Bacillus coagulans, along with prebiotic components and vitamins, has shown potential in positively influencing gut microbiota composition and metabolic activity in healthy individuals.
Based on these promising findings, further investigation is warranted to evaluate the potential of Prolife 10 FORTE in improving the gut microbiota composition of UC patients during the remission phase.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- ButirBioma + PeaBioma, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButirBioma + PeaBiomaDietary supplement
randomized in a 1:1 ratio to treatment Butir+Pea or treatment with Placebo for six weeks. After the first treatment period, there is a 14-day washout period.
PlaceboDietary supplement
Placebo( 3+3 cps/die)
| Study group | Role | What they receive |
|---|---|---|
| ButirBioma+PeaBioma | Active comparator | Treatment : 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 Receives: Dietary Supplement: ButirBioma + PeaBioma |
| Placebo | Placebo comparator | Treatment Placebo :(3+3/day capsules of starch). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the variation of gut microbiota composition (Microbiota test )
Collection of faecal sample for the assessment of the faecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
Measured: 9 months
Secondary outcomes (3)
Evaluation of intestinal permeability(4 sugar test: Gastropack)
- Analysis of mannitol( normal range 15-25%), lactulose( n.r. 0,45%-0,75%), sucrose(normal < 0,15%) and sucralose( normal<1,5%); L/M (normal <0.03%; borderline 0,03%-0,09%; >0.09 severe):
- a capillary blood sample for the detection of Zonulin (Healthy gut Kit) )/Immundiagnostik AG )( normal cut-off 6-10 ng/mL)
Measured: 12 months
Evaluation of Gastrointestinal symptoms( questionary)
Every evening during the two treatment periods, subjects must record a VAS(Visual Analogue Scale : 1-10; 1= non pain; 10= worst pain possible) questionnaire to assess gastrointestinal symptoms and the Stool Bristol Scale.( 1-7; normal 3-4)
Measured: 4 months
Evaluation of Quality of Life (IBS-SSS score) (questionary)
At the visit time points, subjects will have to record the IBS-SSS score( points 75-174 mild, 175-300 moderate; >300 severe)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start8 Mar 2024
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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
- The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch). Eligible subjects with IBS will be randomized in a 1:1 ratio to the treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period. Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edoardo Savarino, Prof,MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432569
- Sponsor's protocol ID
- 5475-AO-22
- Acronym
- B/P3_1
- Status last verified
- Jul 2025
- First submitted
- 27 Feb 2023
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Butyrate and Palmitoylethanolamide Effects on Intestinal Permeability and Microbiota Gut Composition in Patients With Irritable Bowel Syndrome - A Double-blind, Placebo-controlled Crossover Randomized Study
- ClinicalTrials.gov ID
- NCT06432569
- Acronym / sponsor ID
- B/P3_1 / 5475-AO-22
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 29 May 2024 (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.
Evaluation of the effects of butyrate ( BitirBioma) and palmitoylethanolamide( PEA=PeaBioma) on intestinal permeability and gut microbiota composition in patients with irritable bowel syndrome.
Study B/P 3_1 is an interventional study involving the use of food supplements on the market (BitirBioma Plus and PeaBioma Plus), single-center, double-blind, placebo-controlled, crossover, randomized, in n=50 patients with bowel syndrome irritable, diarrheal and mixed variant (IBS-D and IBS-M), lasting for one year.
The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch).
Eligible subjects with IBS will be randomized in a 1:1 ratio to treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period.
Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design.
In the two treatment periods, subjects will be required to complete a visual analogue score VAS questionnaire to assess gastrointestinal symptoms and Stool Bristol Scales. During the visit, the subjects will have to record Questionnaire Rome IV to evaluate their quality of life. At the same time, it will be theirs required to provide:
- fecal sample for the evaluation of the composition of fecal microbiota (Biomaplan Kit)
- a urine sample for the evaluation of intestinal permeability (Gastropack) a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG )
- a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG )
Detailed description
Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon, characterized by relapsing and remitting mucosal inflammation. It presents with symptoms like bloody diarrhea, rectal urgency, fatigue, and abdominal pain. While various therapies are available for managing UC, including medications like amino salicylates, corticosteroids, immunomodulators, and biologics, there's ongoing research into supportive treatments like probiotics.
Probiotics are beneficial microorganisms that can positively influence gut health by modifying the gut microbiota, improving intestinal barrier function, and balancing immune response. Several studies have investigated their efficacy in UC management. Notably, the probiotic mixture VSL#3, containing strains of Lactobacillus and Bifidobacteria, has shown promising results in inducing remission in UC patients.
Other probiotic products like E. coli Nissle 1917, L. rhamnosus GG, and L. casei DG have also demonstrated effectiveness in maintaining disease remission or prolonging relapse-free periods in UC patients. The product Prolife 10 FORTE, containing multiple strains of Lactobacillus, Bifidobacteria, and Bacillus coagulans, along with prebiotic components and vitamins, has shown potential in positively influencing gut microbiota composition and metabolic activity in healthy individuals.
Based on these promising findings, further investigation is warranted to evaluate the potential of Prolife 10 FORTE in improving the gut microbiota composition of UC patients during the remission phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch). Eligible subjects with IBS will be randomized in a 1:1 ratio to the treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period. Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design.
| Arm | Type | Receives |
|---|---|---|
| ButirBioma+PeaBioma | Active comparator | Dietary Supplement: ButirBioma + PeaBiomaTreatment : 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTreatment Placebo :(3+3/day capsules of starch). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ● IBS patients (both males and females) with positive diagnosis based on Rome IV criteria (IBS-D and IBS-M)
Key exclusion criteria (10 listed)
- -Any relevant organic, systemic or metabolic disease, including celiac disease, IDDM (Insulin- Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapses, urinary incontinence, ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease.
- Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
- Prior major gastrointestinal surgeries
- Females of childbearing potential, in the absence of effective contraceptive methods
- Subjects who become unable to conform to protocol
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 |
|---|---|---|
| ButirBioma + PeaBiomarandomized in a 1:1 ratio to treatment Butir+Pea or treatment with Placebo for six weeks. After the first treatment period, there is a 14-day washout period. | Dietary supplement | ButirBioma+PeaBioma |
| PlaceboPlacebo( 3+3 cps/die) | Dietary supplement | Placebo |
Primary outcome
Evaluation of the variation of gut microbiota composition (Microbiota test )
Time frame: 9 months
Collection of faecal sample for the assessment of the faecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
3 secondary outcomes
Evaluation of intestinal permeability(4 sugar test: Gastropack)
Time frame: 12 months
Evaluation of Gastrointestinal symptoms( questionary)
Time frame: 4 months
Evaluation of Quality of Life (IBS-SSS score) (questionary)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Edoardo Savarino, Prof,MD 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 ButirBioma + PeaBioma in people with Irritable Bowel Syndrome With Diarrhea, 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 10 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: finished, as of the sponsor's last update on 10 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the variation of gut microbiota composition (Microbiota test ) (time frame: 9 months). 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 10 Jul 2025.