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Dietary Interventions and Butyrate Production in Behçet's Patients

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ClinicalTrials.gov Identifier: NCT03274648
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
GIACOMO EMMI, Azienda Ospedaliero-Universitaria Careggi

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.

Condition or disease Intervention/treatment Phase
BehçEt Disease Dietary Supplement: Oral butyrate Dietary Supplement: Vegetarian diet Dietary Supplement: Habitual diet Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Modulation of Butyrate Production in Behçet's Patients: a Dietary Intervention Trial
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vegetarian Diet

Arm Intervention/treatment
Experimental: vegetarian diet
vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
Dietary Supplement: 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

Experimental: Habitual diet + oral butyrate
habitual diet supplemented with 2.4g/day of oral butyrate
Dietary Supplement: Oral butyrate
Patients follow the habitual diet supplemented with 2.4g/day of oral butyrate

Active Comparator: Habitual diet
habitual diet without supplementation
Dietary Supplement: Habitual diet
Patients follow the habitual diet




Primary Outcome Measures :
  1. Evaluation of gut microbiota composition [ Time Frame: 0-3 months ]
  2. 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]

  3. Complete blood count [ Time Frame: 0-3 months ]
    composite score

  4. 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

  5. Glycemic profile [ Time Frame: 0-3 months ]
    composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index

  6. Vitamin profile [ Time Frame: 0-3 months ]
    composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D

  7. 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

  8. Kidney function tests [ Time Frame: 0-3 months ]
    composite score taking into account the levels of : serum creatinine, urea, uric acid

  9. Mineral profile [ Time Frame: 0-3 months ]
    composite score taking into account the levels of: sodium, potassium, magnesium, calcium

  10. Iron metabolism [ Time Frame: 0-3 months ]
    composite score taking into account the levels of: iron, ferritin

  11. Thyroid function [ Time Frame: 0-3 months ]
    measurement of TSH levels

  12. 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)

  13. 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)

  14. Circulating levels of inflammatory cytokines [ Time Frame: 0-3 months ]
    composite score

  15. Oxidative stress markers [ Time Frame: 0-3 months ]
    composite score


Secondary Outcome Measures :
  1. Evaluation Behçet's symptoms frequency and severity [ Time Frame: 0-3 months ]
    Participants are asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274648


Contacts
Contact: Giacomo Emmi, MD 0039 055 7947520 giacomo.emmi@unifi.it

Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi

Publications:
Responsible Party: GIACOMO EMMI, Principal Investigator, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT03274648     History of Changes
Other Study ID Numbers: butyrate2017
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No