Behcet SyndromeNCT03274648
Dietary Interventions and Butyrate Production in Behçet's Patients
A study testing Oral butyrate, Vegetarian diet and Habitual diet in people with Behcet Syndrome, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
A dietary intervention trial will be performed on patients affected by Behçet's syndrome. Three different diets will be compared, analyzing their effects on the gut microbiota composition, on endogenous butyrate production and on the general symptoms in Behçet's patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Behcet Syndrome
- What is being tested?
- Oral butyrate, Vegetarian diet and Habitual diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2017to 5 Jul 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients affected by Behçet's disease
Who cannot join
- Pregnancy or breastfeeding
- Presence of diabetes mellitus
- Presence of other immune-mediated diseases
- Presence or history of cancer in the last 5 years
- Presence of infectious diseases in the last 3 months
- No antibiotic therapy in the last 3 months
- No vegetarian or vegan diet
- No intake of pro- or pre-biotics in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Modulation of Butyrate Production in Behçet's Patients: a Dietary Intervention Trial
A dietary intervention trial will be performed on patients affected by Behçet's syndrome. Three different diets will be compared, analyzing their effects on the gut microbiota composition, on endogenous butyrate production and on the general symptoms in Behçet's patients.
Read the detailed description
A dietary intervention trial will be conducted with the use of three different diets in order to compare the effects of these diets on the gut microbiota composition, on endogenous butyrate production and on the general symptoms in Behçet's patients.
The study will be a randomized, open trial designed to test whether a vegetarian diet or an habitual diet supplemented with oral butyrate would benefit the butyrate production, the gut microbiota composition and the general symptoms of Behçet's patients, compared with the habitual diet.
The study will involve 30 subjects with Behçet syndrome. Patients will be randomly assigned to follow a 3-months isocaloric dietary profile with either:
- vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
- habitual diet supplemented with 2.4g/day of oral butyrate
- habitual diet without supplementation At the baseline visit, subjects will be educated about the aims and methods of the clinical trial and will sign their informed consent form.
Anthropometric measurements, body composition, and blood and stool sampling will be obtained from each participant at the beginning and at the end of the intervention period. All subjects will be examined between 07.00 and 09.30 hours after a 12 h fasting period.
The following parameters will be analyzed both at the beginning and at the end of the intervention period:
- Complete blood count
- Lipid variables - total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides
- Glycemic profile - glucose, insulin, glycated hemoglobin (HbA1C), HOMA index
- Liver function tests - aspartate aminotransferase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin
- Kidney function tests - serum creatinine, urea, uric acid
- Mineral profile - sodium, potassium, magnesium, calcium
- Iron metabolism - iron, ferritin
- Vitamin profile - vitamin B12, folic acid, vitamin D
- Thyroid function - TSH
- Inflammatory markers - erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)
- Serology for celiac disease - IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)
- Circulating levels of inflammatory cytokines
- Oxidative stress markers
- Gut microbiota composition
- Butyrate production
At the beginning and at the end of the intervention period, participants will be asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity. In addition, participants will be contacted by phone to complete a 24-hours recall in order to test the adherence to diets they have been assigned to.
- Conditions
- Behcet Syndrome
- Being tested
- Oral butyrate, Vegetarian diet, Habitual diet
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral butyrateDietary supplement
Patients follow the habitual diet supplemented with 2.4g/day of oral butyrate
Vegetarian dietDietary supplement
Patients follow a vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
Habitual dietDietary supplement
Patients follow the habitual diet
| Study group | Role | What they receive |
|---|---|---|
| vegetarian diet | Experimental | vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products Receives: Dietary Supplement: Vegetarian diet |
| Habitual diet + oral butyrate | Experimental | habitual diet supplemented with 2.4g/day of oral butyrate Receives: Dietary Supplement: Oral butyrate |
| Habitual diet | Active comparator | habitual diet without supplementation Receives: Dietary Supplement: Habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of gut microbiota composition
Measured: 0-3 months
Evaluation of butyrate production
For the extraction of SCFAs (and butyrate in particular) the method described in Schnorr et al. will be follow" [Schnorr SL, Candela M, Rampelli S, Centanni M, Consolandi C, Basaglia G,et al. Gut microbiome of the Hadza hunter-gatherers. Nat Commun 2014;5:3654]
Measured: 0-3 months
Complete blood count
composite score
Measured: 0-3 months
Lipid variables
composite score taking into account the levels of: total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides
Measured: 0-3 months
Glycemic profile
composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index
Measured: 0-3 months
Vitamin profile
composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D
Measured: 0-3 months
Liver function tests
composite score taking into account the levels of: aspartate aminotransferase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin
Measured: 0-3 months
Kidney function tests
composite score taking into account the levels of : serum creatinine, urea, uric acid
Measured: 0-3 months
Mineral profile
composite score taking into account the levels of: sodium, potassium, magnesium, calcium
Measured: 0-3 months
Iron metabolism
composite score taking into account the levels of: iron, ferritin
Measured: 0-3 months
Thyroid function
measurement of TSH levels
Measured: 0-3 months
Inflammatory markers
composite score taking into account the levels of: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)
Measured: 0-3 months
Serology for celiac disease
composite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)
Measured: 0-3 months
Circulating levels of inflammatory cytokines
composite score
Measured: 0-3 months
Oxidative stress markers
composite score
Measured: 0-3 months
Secondary outcomes (1)
Evaluation Behçet's symptoms frequency and severity
Participants are asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity.
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start27 Sep 2017
- Primary completion1 May 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Behcet SyndromeStudies 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
- Parallel groups
- Model description
- Behçet's will be assigned to one of the following treatments: * vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products * habitual diet supplemented with 2.4g/day of oral butyrate * habitual diet without supplementation
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIACOMO EMMI, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274648
- Sponsor's protocol ID
- butyrate2017
- Status last verified
- Jan 2020
- First submitted
- 31 Aug 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Publications
Skef W, Hamilton MJ, Arayssi T. Gastrointestinal Behcet's disease: a review. World J Gastroenterol. 2015 Apr 7;21(13):3801-12. doi: 10.3748/wjg.v21.i13.3801.
PubMed 25852265Consolandi C, Turroni S, Emmi G, Severgnini M, Fiori J, Peano C, Biagi E, Grassi A, Rampelli S, Silvestri E, Centanni M, Cianchi F, Gotti R, Emmi L, Brigidi P, Bizzaro N, De Bellis G, Prisco D, Candela M, D'Elios MM. Behcet's syndrome patients exhibit specific microbiome signature. Autoimmun Rev. 2015 Apr;14(4):269-76. doi: 10.1016/j.autrev.2014.11.009. Epub 2014 Nov 27.
PubMed 25435420Wong JM. Gut microbiota and cardiometabolic outcomes: influence of dietary patterns and their associated components. Am J Clin Nutr. 2014 Jul;100 Suppl 1:369S-77S. doi: 10.3945/ajcn.113.071639. Epub 2014 Jun 4.
PubMed 24898225
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Modulation of Butyrate Production in Behçet's Patients: a Dietary Intervention Trial
- ClinicalTrials.gov ID
- NCT03274648
- Acronym / sponsor ID
- butyrate2017
- Conditions
- Behcet Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 7 Sep 2017 (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.
A dietary intervention trial will be performed on patients affected by Behçet's syndrome. Three different diets will be compared, analyzing their effects on the gut microbiota composition, on endogenous butyrate production and on the general symptoms in Behçet's patients.
Detailed description
A dietary intervention trial will be conducted with the use of three different diets in order to compare the effects of these diets on the gut microbiota composition, on endogenous butyrate production and on the general symptoms in Behçet's patients.
The study will be a randomized, open trial designed to test whether a vegetarian diet or an habitual diet supplemented with oral butyrate would benefit the butyrate production, the gut microbiota composition and the general symptoms of Behçet's patients, compared with the habitual diet.
The study will involve 30 subjects with Behçet syndrome. Patients will be randomly assigned to follow a 3-months isocaloric dietary profile with either:
- vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
- habitual diet supplemented with 2.4g/day of oral butyrate
- habitual diet without supplementation At the baseline visit, subjects will be educated about the aims and methods of the clinical trial and will sign their informed consent form.
Anthropometric measurements, body composition, and blood and stool sampling will be obtained from each participant at the beginning and at the end of the intervention period. All subjects will be examined between 07.00 and 09.30 hours after a 12 h fasting period.
The following parameters will be analyzed both at the beginning and at the end of the intervention period:
- Complete blood count
- Lipid variables - total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides
- Glycemic profile - glucose, insulin, glycated hemoglobin (HbA1C), HOMA index
- Liver function tests - aspartate aminotransferase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin
- Kidney function tests - serum creatinine, urea, uric acid
- Mineral profile - sodium, potassium, magnesium, calcium
- Iron metabolism - iron, ferritin
- Vitamin profile - vitamin B12, folic acid, vitamin D
- Thyroid function - TSH
- Inflammatory markers - erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)
- Serology for celiac disease - IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)
- Circulating levels of inflammatory cytokines
- Oxidative stress markers
- Gut microbiota composition
- Butyrate production
At the beginning and at the end of the intervention period, participants will be asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity. In addition, participants will be contacted by phone to complete a 24-hours recall in order to test the adherence to diets they have been assigned to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Behçet's will be assigned to one of the following treatments: * vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products * habitual diet supplemented with 2.4g/day of oral butyrate * habitual diet without supplementation
| Arm | Type | Receives |
|---|---|---|
| vegetarian diet | Experimental | Dietary Supplement: Vegetarian dietvegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products |
| Habitual diet + oral butyrate | Experimental | Dietary Supplement: Oral butyratehabitual diet supplemented with 2.4g/day of oral butyrate |
| Habitual diet | Active comparator | Dietary Supplement: Habitual diethabitual diet without supplementation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients affected by Behçet's disease
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- Presence of diabetes mellitus
- Presence of other immune-mediated diseases
- Presence or history of cancer in the last 5 years
- Presence of infectious diseases in the last 3 months
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 |
|---|---|---|
| Oral butyratePatients follow the habitual diet supplemented with 2.4g/day of oral butyrate | Dietary supplement | Habitual diet + oral butyrate |
| Vegetarian dietPatients follow a vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products | Dietary supplement | vegetarian diet |
| Habitual dietPatients follow the habitual diet | Dietary supplement | Habitual diet |
Primary outcome
Evaluation of gut microbiota composition
Time frame: 0-3 months
Evaluation of butyrate production
Time frame: 0-3 months
For the extraction of SCFAs (and butyrate in particular) the method described in Schnorr et al. will be follow" [Schnorr SL, Candela M, Rampelli S, Centanni M, Consolandi C, Basaglia G,et al. Gut microbiome of the Hadza hunter-gatherers. Nat Commun 2014;5:3654]
Complete blood count
Time frame: 0-3 months
composite score
Lipid variables
Time frame: 0-3 months
composite score taking into account the levels of: total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides
Glycemic profile
Time frame: 0-3 months
composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index
Vitamin profile
Time frame: 0-3 months
composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D
Liver function tests
Time frame: 0-3 months
composite score taking into account the levels of: aspartate aminotransferase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin
Kidney function tests
Time frame: 0-3 months
composite score taking into account the levels of : serum creatinine, urea, uric acid
Mineral profile
Time frame: 0-3 months
composite score taking into account the levels of: sodium, potassium, magnesium, calcium
Iron metabolism
Time frame: 0-3 months
composite score taking into account the levels of: iron, ferritin
Thyroid function
Time frame: 0-3 months
measurement of TSH levels
Inflammatory markers
Time frame: 0-3 months
composite score taking into account the levels of: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)
Serology for celiac disease
Time frame: 0-3 months
composite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)
Circulating levels of inflammatory cytokines
Time frame: 0-3 months
composite score
Oxidative stress markers
Time frame: 0-3 months
composite score
1 secondary outcome
Evaluation Behçet's symptoms frequency and severity
Time frame: 0-3 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 28 Jan 2020.
- Background: PubMed 25852265Skef W, Hamilton MJ, Arayssi T. Gastrointestinal Behcet's disease: a review. World J Gastroenterol. 2015 Apr 7;21(13):3801-12. doi: 10.3748/wjg.v21.i13.3801.
- Background: PubMed 25435420Consolandi C, Turroni S, Emmi G, Severgnini M, Fiori J, Peano C, Biagi E, Grassi A, Rampelli S, Silvestri E, Centanni M, Cianchi F, Gotti R, Emmi L, Brigidi P, Bizzaro N, De Bellis G, Prisco D, Candela M, D'Elios MM. Behcet's syndrome patients exhibit specific microbiome signature. Autoimmun Rev. 2015 Apr;14(4):269-76. doi: 10.1016/j.autrev.2014.11.009. Epub 2014 Nov 27.
- Background: PubMed 24898225Wong JM. Gut microbiota and cardiometabolic outcomes: influence of dietary patterns and their associated components. Am J Clin Nutr. 2014 Jul;100 Suppl 1:369S-77S. doi: 10.3945/ajcn.113.071639. Epub 2014 Jun 4.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral butyrate, Vegetarian diet and Habitual diet in people with Behcet Syndrome, run by Azienda Ospedaliero-Universitaria Careggi 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 1 inclusion and 8 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 28 Jan 2020. 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?
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 gut microbiota composition (time frame: 0-3 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274648, which also lists 3 linked publications.
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 28 Jan 2020.