Dietary Interventions and Butyrate Production in Behçet's Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-27

Study Completion Date

2019-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of a Low- Fermentable-Oligo-Di- Monosaccharides and Polyols Diet Group Intervention on IBS Symptoms and Fatigue

NCT05124262

Irritable Bowel Syndrome

NOT_YET_RECRUITING NA

The Effects of Carbohydrates in Irritable Bowel Syndrome

NCT04830410

Irritable Bowel Syndrome With Diarrhea

COMPLETED NA

Effect of Butyrogenic Fibers in IBS Patients

NCT00314886

Irritable Bowel Syndrome

UNKNOWN NA

Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition

NCT06420843

IBS - Irritable Bowel Syndrome

RECRUITING NA

Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

NCT02161120

Irritable Bowel Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Behcet Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vegetarian diet

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

Group Type EXPERIMENTAL