Dietary Interventions and Butyrate Production in Behçet's Patients

January 27, 2020 updated by: GIACOMO EMMI, Azienda Ospedaliero-Universitaria Careggi

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50134
        • AOU Careggi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of gut microbiota composition
Time Frame: 0-3 months
0-3 months
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]
0-3 months
Complete blood count
Time Frame: 0-3 months
composite score
0-3 months
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
0-3 months
Glycemic profile
Time Frame: 0-3 months
composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index
0-3 months
Vitamin profile
Time Frame: 0-3 months
composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D
0-3 months
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
0-3 months
Kidney function tests
Time Frame: 0-3 months
composite score taking into account the levels of : serum creatinine, urea, uric acid
0-3 months
Mineral profile
Time Frame: 0-3 months
composite score taking into account the levels of: sodium, potassium, magnesium, calcium
0-3 months
Iron metabolism
Time Frame: 0-3 months
composite score taking into account the levels of: iron, ferritin
0-3 months
Thyroid function
Time Frame: 0-3 months
measurement of TSH levels
0-3 months
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)
0-3 months
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)
0-3 months
Circulating levels of inflammatory cytokines
Time Frame: 0-3 months
composite score
0-3 months
Oxidative stress markers
Time Frame: 0-3 months
composite score
0-3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
0-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliero-Universitaria Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • butyrate2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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