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Gut Microbiota and Behcet's Syndrome: a Dietary Intervention Trial (MAMBA Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03962335
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi

Brief Summary:
Behçet's syndrome (BS) is an idiopathic, chronic, multi-systemic inflammatory disorder characterized by ocular disease, skin lesions, vascular, neurological and gastrointestinal involvement. A recent study showed a peculiar dysbiosis of gut microbiota (GM) in BS patients, with specific changes in the profiles of short-chain fatty acids, especially butyrate. Over the last few years, a growing interest on the role of GM in metabolic disturbances has been manifested. Diet is one of the major factors driving the GM composition and functionality. In this context, the influence of diets generally recognized healthy on GM has been explored, but consistent data on autoimmune and inflammatory diseases are not available. The aim of this intervention study is to investigate whether a lacto-ovo-vegetarian diet enriched in substrates with potential for butyrate production or a Mediterranean diet supplemented with oral butyrate could be beneficial for GM and metabolic risk profile in BS.

Condition or disease Intervention/treatment Phase
Behcet Syndrome Behavioral: Vegetarian diet Behavioral: Mediterranean diet with butyrate Behavioral: Mediterranean diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover open dietary intervention study with 3 arms of intervention
Masking: None (Open Label)
Masking Description: In this trial blinding of participants and investigators will not be possible because of obvious differences between the intervention diets
Primary Purpose: Treatment
Official Title: ModulAtion of Gut Microbiota Through Nutritional Interventions in Behcet's Syndrome pAtients: the MAMBA Study
Actual Study Start Date : January 6, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Experimental: VD group
Group that starts with Vegetarian diet (VD)
Behavioral: Vegetarian diet
7-days dietary profile with a Vegetarian diet (VD), containing inulin and resistant starch-rich foods and including no meat and fish, but containing eggs and dairy, for 3 months
Other Name: VD

Behavioral: Mediterranean diet with butyrate
7-days dietary profile with Mediterranean diet with oral supplementation with butyrate (MD+Bt), 2 g/day, for 3 months
Other Name: MD+Bt

Behavioral: Mediterranean diet
7-days dietary profile with Mediterranean diet (MD), including 2 portions per week of fish and 3 portions per week of fresh and processed meat (2 of which fresh or processed red meat), for 3 months
Other Name: MD

Experimental: MD+Bt group
Group that starts with Mediterranean diet with oral supplementation with butyrate (MD+Bt)
Behavioral: Vegetarian diet
7-days dietary profile with a Vegetarian diet (VD), containing inulin and resistant starch-rich foods and including no meat and fish, but containing eggs and dairy, for 3 months
Other Name: VD

Behavioral: Mediterranean diet with butyrate
7-days dietary profile with Mediterranean diet with oral supplementation with butyrate (MD+Bt), 2 g/day, for 3 months
Other Name: MD+Bt

Behavioral: Mediterranean diet
7-days dietary profile with Mediterranean diet (MD), including 2 portions per week of fish and 3 portions per week of fresh and processed meat (2 of which fresh or processed red meat), for 3 months
Other Name: MD

Active Comparator: MD group
Group that starts with Mediterranean diet (MD)
Behavioral: Vegetarian diet
7-days dietary profile with a Vegetarian diet (VD), containing inulin and resistant starch-rich foods and including no meat and fish, but containing eggs and dairy, for 3 months
Other Name: VD

Behavioral: Mediterranean diet with butyrate
7-days dietary profile with Mediterranean diet with oral supplementation with butyrate (MD+Bt), 2 g/day, for 3 months
Other Name: MD+Bt

Behavioral: Mediterranean diet
7-days dietary profile with Mediterranean diet (MD), including 2 portions per week of fish and 3 portions per week of fresh and processed meat (2 of which fresh or processed red meat), for 3 months
Other Name: MD




Primary Outcome Measures :
  1. Disease severity of Behcet syndrome assessed by Behçet Disease Current Activity Form [ Time Frame: 1 year ]
    The disease activity will be assessed by the use of the validated Behçet Disease Current Activity Form (BCDAF), at the baseline and after the dietary intervention. The BCDAF will assess the presence of oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache with a 5-point scale according to the duration of symptoms, with 0 meaning no symptoms and 4 meaning symptoms for 4 weeks. The presence of eyes, large vessels or central nervous system (CNS) involvement are document with "yes/no" answers. In addition, patients will be asked to rate on a 7-point scale how active they felt. Similarly, the clinicians will complete a 7-rating scale to assess their opinion of overall activity of the disease, with lower scores representing better outcomes.

  2. Behcet disease's improvement of symptoms assessed by the Global Assessment of Improvement Scale (GAI) modified form [ Time Frame: 1 year ]
    The Global Assessment of Improvement Scale (GAI) modified form will assess Behcet disease's improvement of symptoms using a 7-point scale, with higher scores meaning an improvement of the symptoms. The severity of abdominal pain, severity of abdominal distention, satisfaction with bowel habits, severity of headache, severity of exhaustion, severity of nausea, attention disorder, muscle/joint pain, and quality of life will be investigated in response to the following question: "Compared to the way you felt before you entered the study, have your symptoms over the past 7 days been: 1) "Substantially Worse", 2) "Moderately Worse, 3) "Slightly Worse", 4) "No Change", 5) "Slightly Improved", 6) "Moderately Improved" or 7) "Substantially Improved".

  3. Behcet disease's severity of gastrointestinal symptoms assessed by the Symptom Severity Scale (SSS) modified form [ Time Frame: 1 year ]
    The Symptom Severity Scale (SSS) modified form is a multidimensional rating scale assessing overall symptoms' severity on a Visual Analogue Scale (VAS). An overall score will be calculated from six items: pain severity, pain frequency, abdominal bloating, bowel habit dissatisfaction, abdominal heaviness, and life interference. The modified SSS ranges from 0 to 600, with higher scores meaning more severe symptoms.


Secondary Outcome Measures :
  1. Gut microbiota assessed by Illumina MiSeq platform [ Time Frame: 1 year ]
    Changes of gut microbiota profiles from baseline. The V3 and V4 hypervariable regions of the 16S rRNA gene will be sequenced on Illumina MiSeq platform, following the Illumina protocol for 16S Metagenomic Sequencing Library Preparation

  2. Fecal SCFA assessed by Gas Chromatography - Mass Spectrometry system [ Time Frame: 1 year ]
    Fecal SCFA's change from baseline, especially butyrate, will be assessed by Gas Chromatography - Mass Spectrometry system

  3. Inflammatory profile assessed by cytofluorimetric approach [ Time Frame: 1 year ]
    Inflammatory cytokines' change from baseline, will be assessed with the Bio-Plex cytokine assay, according to the manufacturer's instructions. In particular, Interleukin (IL)-1ra (pg/mL), IL-4 (pg/mL), IL-6 (pg/mL), IL-8 (pg/mL), IL-10 (pg/mL), IL-12 (pg/mL), IL-17 (pg/mL), monocyte chemoattractant protein (MCP)-1 (pg/mL), macrophage inflammatory protein (MIP)-1beta (pg/mL), vascular endothelial growth factor (VEGF) (pg/mL), tumor necrosis factor (TNF)-alpha (pg/mL), interferon (IFN)-gamma (pg/mL), interferon-gamma-induced protein (IP)-10 (pg/mL), will be measured.

  4. Lipid peroxidation assessed by flow cytometry [ Time Frame: 1 year ]
    Lipid peroxidation markers' change from baseline will be estimated using the Thiobarbituric Acid Reactive Substances (TBARS, pg/mL) assay kit through the flow cytometry.

  5. Plasma total antioxidant capacity assessed by the oxygen radical absorbance capacity [ Time Frame: 1 year ]
    Plasma total antioxidant capacity's (TAC, μmol/mL) change from baseline, will be measured using the oxygen radical absorbance capacity.

  6. Reactive oxygen species (ROS) assessed by flow cytometry [ Time Frame: 1 year ]
    Leukocyte (lymphocyte, monocyte, and granulocyte) reactive oxygen species' (ROS, RFU) change from baseline will be assessed through flow cytometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Behcet syndrome
  • Age 18-65 years
  • Willing to give informed consent
  • Willing to participate in a study where one of the proposed dietary profile is a vegetarian pattern

Exclusion Criteria:

  • Pregnancy or lactation
  • Concomitant presence of serious illness or unstable condition (autoimmune diseases; chronic viral infections; malignancies, recent myocardial infarction, chronic liver disease, inflammatory bowel diseases)
  • Current or recent (past 6 months) participation in weight loss treatment program or use of weight loss medication
  • Adoption of a vegetarian diet for the past 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): NCT03962335


Contacts
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Contact: Francesco Sofi, MD, PhD +390552758042 francesco.sofi@unifi.it

Locations
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Italy
Unit of Clinical Nutrition, University Hospital of Careggi Recruiting
Florence, Italy, 50134
Contact: Francesco Sofi, MD, PhD    +390552758042    francesco.sofi@unifi.it   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Study Director: Alessandro Casini, MD Unit of Clinical Nutrition, University Hospital of Careggi, Florence, Italy
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesco Sofi, Associate Professor of Clinical Nutrition, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT03962335    
Other Study ID Numbers: MAMBA
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi:
Gut microbiota
Mediterranean diet
Vegetarian diet
Short chain fatty acids
Additional relevant MeSH terms:
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Behcet Syndrome
Syndrome
Disease
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular