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Dietary Interventions and Butyrate Production in Behçet's Patients

Therapeutic Modulation of Butyrate Production in Behçet's Patients: a Dietary Intervention Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03274648
Enrollment
17
Registered
2017-09-07
Start date
2017-09-27
Completion date
2019-07-05
Last updated
2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behcet Syndrome

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTOral butyrate

Patients follow the habitual diet supplemented with 2.4g/day of oral butyrate

DIETARY_SUPPLEMENTVegetarian diet

Patients follow a vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products

DIETARY_SUPPLEMENTHabitual diet

Patients follow the habitual diet

Sponsors

Azienda Ospedaliero-Universitaria Careggi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* All patients affected by Behçet's disease

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stress markers0-3 monthscomposite score
Evaluation of gut microbiota composition0-3 months
Evaluation of butyrate production0-3 monthsFor 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 count0-3 monthscomposite score
Lipid variables0-3 monthscomposite score taking into account the levels of: total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides
Glycemic profile0-3 monthscomposite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index
Vitamin profile0-3 monthscomposite score, taking into account the levels of: vitamin B12, folic acid, vitamin D
Liver function tests0-3 monthscomposite score taking into account the levels of: aspartate aminotransferase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin
Kidney function tests0-3 monthscomposite score taking into account the levels of : serum creatinine, urea, uric acid
Mineral profile0-3 monthscomposite score taking into account the levels of: sodium, potassium, magnesium, calcium
Iron metabolism0-3 monthscomposite score taking into account the levels of: iron, ferritin
Thyroid function0-3 monthsmeasurement of TSH levels
Inflammatory markers0-3 monthscomposite score taking into account the levels of: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)
Serology for celiac disease0-3 monthscomposite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)
Circulating levels of inflammatory cytokines0-3 monthscomposite score

Secondary

MeasureTime frameDescription
Evaluation Behçet's symptoms frequency and severity0-3 monthsParticipants are asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026