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

NCT03962335 | Completed DMC

• 1 other identifier: MAMBA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet Syndrome

Keywords

Gut microbiota; Mediterranean diet; Vegetarian diet; Short chain fatty acids

Outcome Measures

Primary Outcomes (3)

• Disease severity of Behcet syndrome assessed by Behçet Disease Current Activity Form

  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.

  1 year

• Behcet disease's improvement of symptoms assessed by the Global Assessment of Improvement Scale (GAI) modified form

  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".

  1 year

• Behcet disease's severity of gastrointestinal symptoms assessed by the Symptom Severity Scale (SSS) modified form

  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.

  1 year

Secondary Outcomes (6)

• Gut microbiota assessed by Illumina MiSeq platform

  1 year

• Fecal SCFA assessed by Gas Chromatography - Mass Spectrometry system

  1 year

• Inflammatory profile assessed by cytofluorimetric approach

  1 year

• Lipid peroxidation assessed by flow cytometry

  1 year

• Plasma total antioxidant capacity assessed by the oxygen radical absorbance capacity

  1 year

Study Arms (3)

VD group

EXPERIMENTAL

Group that starts with Vegetarian diet (VD)

Behavioral: Vegetarian diet; Behavioral: Mediterranean diet with butyrate; Behavioral: Mediterranean diet

MD+Bt group

EXPERIMENTAL

Group that starts with Mediterranean diet with oral supplementation with butyrate (MD+Bt)

Behavioral: Vegetarian diet; Behavioral: Mediterranean diet with butyrate; Behavioral: Mediterranean diet

MD group

ACTIVE COMPARATOR

Group that starts with Mediterranean diet (MD)

Behavioral: Vegetarian diet; Behavioral: Mediterranean diet with butyrate; Behavioral: Mediterranean diet

Interventions

Vegetarian diet BEHAVIORAL

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

Also known as: VD

MD group; MD+Bt group; VD group

Mediterranean diet with butyrate BEHAVIORAL

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

Also known as: MD+Bt

MD group; MD+Bt group; VD group

Mediterranean diet BEHAVIORAL

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

Also known as: MD

MD group; MD+Bt group; VD group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Unit of Clinical Nutrition, University Hospital of Careggi

Florence, 50134, Italy

Location

Related Publications (14)

• 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

• Neish AS. Microbes in gastrointestinal health and disease. Gastroenterology. 2009 Jan;136(1):65-80. doi: 10.1053/j.gastro.2008.10.080. Epub 2008 Nov 19.

  PMID: 19026645 BACKGROUND

• Candela M, Rampelli S, Turroni S, Severgnini M, Consolandi C, De Bellis G, Masetti R, Ricci G, Pession A, Brigidi P. Unbalance of intestinal microbiota in atopic children. BMC Microbiol. 2012 Jun 6;12:95. doi: 10.1186/1471-2180-12-95.

  PMID: 22672413 BACKGROUND

• Kosiewicz MM, Dryden GW, Chhabra A, Alard P. Relationship between gut microbiota and development of T cell associated disease. FEBS Lett. 2014 Nov 17;588(22):4195-206. doi: 10.1016/j.febslet.2014.03.019. Epub 2014 Mar 26.

  PMID: 24681103 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

• Sonnenburg ED, Sonnenburg JL. Starving our microbial self: the deleterious consequences of a diet deficient in microbiota-accessible carbohydrates. Cell Metab. 2014 Nov 4;20(5):779-786. doi: 10.1016/j.cmet.2014.07.003. Epub 2014 Aug 21.

  PMID: 25156449 BACKGROUND

• Kabeerdoss J, Devi RS, Mary RR, Ramakrishna BS. Faecal microbiota composition in vegetarians: comparison with omnivores in a cohort of young women in southern India. Br J Nutr. 2012 Sep 28;108(6):953-7. doi: 10.1017/S0007114511006362. Epub 2011 Dec 20.

  PMID: 22182464 BACKGROUND

• Haro C, Montes-Borrego M, Rangel-Zuniga OA, Alcala-Diaz JF, Gomez-Delgado F, Perez-Martinez P, Delgado-Lista J, Quintana-Navarro GM, Tinahones FJ, Landa BB, Lopez-Miranda J, Camargo A, Perez-Jimenez F. Two Healthy Diets Modulate Gut Microbial Community Improving Insulin Sensitivity in a Human Obese Population. J Clin Endocrinol Metab. 2016 Jan;101(1):233-42. doi: 10.1210/jc.2015-3351. Epub 2015 Oct 27.

  PMID: 26505825 BACKGROUND

• Candela M, Biagi E, Soverini M, Consolandi C, Quercia S, Severgnini M, Peano C, Turroni S, Rampelli S, Pozzilli P, Pianesi M, Fallucca F, Brigidi P. Modulation of gut microbiota dysbioses in type 2 diabetic patients by macrobiotic Ma-Pi 2 diet. Br J Nutr. 2016 Jul;116(1):80-93. doi: 10.1017/S0007114516001045. Epub 2016 May 6.

  PMID: 27151248 BACKGROUND

• Candela M, Maccaferri S, Turroni S, Carnevali P, Brigidi P. Functional intestinal microbiome, new frontiers in prebiotic design. Int J Food Microbiol. 2010 Jun 15;140(2-3):93-101. doi: 10.1016/j.ijfoodmicro.2010.04.017. Epub 2010 Apr 24.

  PMID: 20471127 BACKGROUND

• International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26.

  PMID: 23441863 BACKGROUND

• Munoz-Gonzalez I, Jimenez-Giron A, Martin-Alvarez PJ, Bartolome B, Moreno-Arribas MV. Profiling of microbial-derived phenolic metabolites in human feces after moderate red wine intake. J Agric Food Chem. 2013 Oct 2;61(39):9470-9. doi: 10.1021/jf4025135. Epub 2013 Sep 19.

  PMID: 24010549 BACKGROUND

• Pagliai G, Dinu M, Fiorillo C, Becatti M, Turroni S, Emmi G, Sofi F. Modulation of gut microbiota through nutritional interventions in Behcet's syndrome patients (the MAMBA study): study protocol for a randomized controlled trial. Trials. 2020 Jun 9;21(1):511. doi: 10.1186/s13063-020-04444-6.

  PMID: 32517729 DERIVED

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Diet, Vegetarian; Diet, Mediterranean; Butyrates

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)

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

Study Officials

• Alessandro Casini, MD

  Unit of Clinical Nutrition, University Hospital of Careggi, Florence, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this trial blinding of participants and investigators will not be possible because of obvious differences between the intervention diets
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Nutrition

Model Details: Randomized crossover open dietary intervention study with 3 arms of intervention

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 24, 2019
• Study Start: January 6, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

IT (1)