MedTrace Logo

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

NCT03962335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-02-02

No results posted yet for this study

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

Interventions

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

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

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

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Alessandro Casini, MD · Unit of Clinical Nutrition, University Hospital of Careggi, Florence, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-06
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03962335 on ClinicalTrials.gov