Dietary Interventions and Butyrate Production in Behçet's Patients

Behcet Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274648
• Other study ID #: butyrate2017
• Status: Completed
• Phase: N/A
• Start date: September 27, 2017
• Est. completion date: July 5, 2019

Study information

• Verified date: January 2020
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 5, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Behcet Syndrome

Intervention

Dietary Supplement:
• Oral butyrate
Patients follow the habitual diet supplemented with 2.4g/day of oral butyrate
• Vegetarian diet
Patients follow a vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
• Habitual diet
Patients follow the habitual diet

Locations

Country	Name	City	State
Italy	AOU Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Consolandi 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. Behçet'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. — View Citation

Skef W, Hamilton MJ, Arayssi T. Gastrointestinal Behçet's disease: a review. World J Gastroenterol. 2015 Apr 7;21(13):3801-12. doi: 10.3748/wjg.v21.i13.3801. Review. — View Citation

Wong 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of gut microbiota composition		0-3 months
Primary	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]	0-3 months
Primary	Complete blood count	composite score	0-3 months
Primary	Lipid variables	composite score taking into account the levels of: total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides	0-3 months
Primary	Glycemic profile	composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index	0-3 months
Primary	Vitamin profile	composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D	0-3 months
Primary	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	0-3 months
Primary	Kidney function tests	composite score taking into account the levels of : serum creatinine, urea, uric acid	0-3 months
Primary	Mineral profile	composite score taking into account the levels of: sodium, potassium, magnesium, calcium	0-3 months
Primary	Iron metabolism	composite score taking into account the levels of: iron, ferritin	0-3 months
Primary	Thyroid function	measurement of TSH levels	0-3 months
Primary	Inflammatory markers	composite score taking into account the levels of: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)	0-3 months
Primary	Serology for celiac disease	composite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)	0-3 months
Primary	Circulating levels of inflammatory cytokines	composite score	0-3 months
Primary	Oxidative stress markers	composite score	0-3 months
Secondary	Evaluation Behçet's symptoms frequency and severity	Participants are asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity.	0-3 months