Dietary Interventions and Butyrate Production in Behçet's Patients

NCT03274648 | Completed

• 1 other identifier: butyrate2017
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet Syndrome

Outcome Measures

Primary Outcomes (15)

• Evaluation of gut microbiota composition

  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" \[Schnorr SL, Candela M, Rampelli S, Centanni M, Consolandi C, Basaglia G,et al. Gut microbiome of the Hadza hunter-gatherers. Nat Commun 2014;5:3654\]

  0-3 months

• Complete blood count

  composite score

  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

  0-3 months

• Glycemic profile

  composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index

  0-3 months

• Vitamin profile

  composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D

  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

  0-3 months

• Kidney function tests

  composite score taking into account the levels of : serum creatinine, urea, uric acid

  0-3 months

• Mineral profile

  composite score taking into account the levels of: sodium, potassium, magnesium, calcium

  0-3 months

• Iron metabolism

  composite score taking into account the levels of: iron, ferritin

  0-3 months

• Thyroid function

  measurement of TSH levels

  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)

  0-3 months

• Serology for celiac disease

  composite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)

  0-3 months

• Circulating levels of inflammatory cytokines

  composite score

  0-3 months

• Oxidative stress markers

  composite score

  0-3 months

Secondary Outcomes (1)

• Evaluation Behçet's symptoms frequency and severity

  0-3 months

Study Arms (3)

vegetarian diet

EXPERIMENTAL

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 diet + oral butyrate

EXPERIMENTAL

habitual diet supplemented with 2.4g/day of oral butyrate

Dietary Supplement: Oral butyrate

Habitual diet

ACTIVE COMPARATOR

habitual diet without supplementation

Dietary Supplement: Habitual diet

Interventions

Oral butyrate DIETARY_SUPPLEMENT

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

Habitual diet + oral butyrate

Vegetarian diet DIETARY_SUPPLEMENT

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

vegetarian diet

Habitual diet DIETARY_SUPPLEMENT

Patients follow the habitual diet

Habitual diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients affected by Behçet's disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

AOU Careggi

Florence, 50134, Italy

Location

Related Publications (3)

• 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.

  PMID: 25852265 BACKGROUND

• 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. 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.

  PMID: 25435420 BACKGROUND

• 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.

  PMID: 24898225 BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Butyrates; Diet, Vegetarian

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 7, 2017
• Study Start: September 27, 2017
• Primary Completion: May 1, 2019
• Study Completion: July 5, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)