Evidence map›Paper›PMID 32517729›Full record

ArticleTrials2020

Modulation of gut microbiota through nutritional interventions in Behçet's syndrome patients (the MAMBA study): study protocol for a randomized controlled trial.

Giuditta Pagliai, Monica Dinu, Claudia Fiorillo, Matteo Becatti, Silvia Turroni, Giacomo Emmi, Francesco Sofi

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03962335 (ModulAtion of Gut Microbiota Through Nutritional Interventions in Behcet's Syndrome pAtients), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03962335 nacompletednot on this map

ModulAtion of Gut Microbiota Through Nutritional Interventions in Behcet's Syndrome pAtients: the MAMBA Study

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria CareggiRan2019 to 2023Enrolled90ConditionsBehcet SyndromeArmsVegetarian diet, Mediterranean diet with butyrate, Mediterranean diet
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Microbiome in Immune-Mediated Uveitis.International journal of molecular sciences · 2022
    Review
  8. Review
  9. Findings on the Relationship Between Intestinal Microbiome and Vasculitis.Frontiers in cellular and infection microbiology · 2022
    Review
  10. A Contemporary Review of Behcet's Syndrome.Clinical reviews in allergy & immunology · 2021
    Review
  11. Article
  12. Review
  13. Review
  14. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Giuditta PagliaiDepartment of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. giuditta.pagliai@gmail.com.ORCID http://orcid.org/0000-0002-2177-2857
Monica DinuDepartment of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
Claudia FiorilloDepartment of Experimental and Clinical Biomedical Sciences "Mario Serio", University of Florence, Florence, Italy.
Matteo BecattiDepartment of Experimental and Clinical Biomedical Sciences "Mario Serio", University of Florence, Florence, Italy.
Silvia TurroniDepartment of Pharmacy and Biotechnology, Unit of Holobiont Microbiome and Microbiome Engineering, University of Bologna, Bologna, Italy.
Giacomo EmmiDepartment of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
Francesco SofiDepartment of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
Azienda Ospedaliero-Universitaria Careggi · ITUniversity of Florence · ITUniversity of Bologna · IT

Funding

Italian Ministry of Health GR-2016-02361162
6 · The paper itself

Abstract

backgroundBehçet's syndrome (BS) is a systemic inflammatory disorder of unknown etiology, and it is characterized by a wide range of potential clinical manifestations. Recent evidence suggests that the gut microbiota (GM) in BS has low biodiversity with a significant depletion in butyrate producers. The aim of the present project is to investigate whether a dietary intervention could ameliorate the clinical manifestations and modulate the GM of individuals with BS.

methodsThis is a randomized, open, cross-over study that involves 90 individuals with BS, who will be randomly assigned to one of three different diets for 3 months: a lacto-ovo-vegetarian diet (VD), a Mediterranean diet (MD), or a Mediterranean diet supplemented with butyrate (MD-Bt). The VD will contain inulin-resistant and resistant-starch-rich foods, eggs, and dairy in addition to plant-based food, but it will not contain meat, poultry, or fish. The MD will contain all food categories and will provide two portions per week of fish and three portions per week of fresh and processed meat. The MD-Bt will be similar to the MD but supplemented with 1.8 g/day of oral butyrate. The three different diets will be isocaloric and related to the participants' nutritional requirements. Anthropometric measurements, body composition, blood, and fecal samples will be obtained from each participant at the beginning and the end of each intervention phase. The primary outcomes will be represented by the change from baseline of the BS gastrointestinal and systemic symptoms. Changes from baseline in GM composition, short-chain fatty acid (SCFA) production, and the inflammatory and antioxidant profile will be considered as secondary outcomes. DISCUSSION: BS is a rare disease, and, actually, not all the available treatments are target therapies. A supportive treatment based on dietary and lifestyle issues, able to restore immune system homeostasis, could have a high impact on cost sustainability for the treatment of such a chronic and disabling inflammatory condition.

trial registrationclinicaltrials.gov: NCT03962335. Registered on 21 May 2019.

Indexed as

Diet, MediterraneanDiet, VegetarianGastrointestinal MicrobiomeBehcet SyndromeBody CompositionButyratesCross-Over StudiesDietary SupplementsFecesHumansRandomized Controlled Trials as TopicRiskButyratesGut microbiotaMediterranean dietShort-chain fatty acidsVegetarian diet

Identifiers

PMID32517729
PMCPMC7282205
OpenAlexW3034075788

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.