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Microbiota and Related Metabolome in Omnivore, Vegetarian or Vegan Diets (MRMOVVD)

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ClinicalTrials.gov Identifier: NCT02118857
Recruitment Status : Unknown
Verified April 2014 by Marco Gobbetti, University of Bari.
Recruitment status was:  Recruiting
First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
The human body houses a huge microbial ecosystem, including the intestinal and oral microbiota. Both these ecosystems, and, in particular, the intestinal one, are responsible for maintaining human health. The response of the organism to the diet and the relative alteration of the susceptibility to disease are worth of investigation to comprehend the role of the microbiota to maintain the state of well being in humans. This concept, which is the overall scientific basis of the entire project, perfectly fits with the declared scopes of Horizon 2020. Understanding the impact of omnivore, vegetarian and vegan diets on human intestinal microbiota is aligned to the Grand Societal Challenge of the Horizon 2020 scheme, which is addressing the human nutritional needs and the impact of food on human physiological functions. In particular, studying the link between dietary habits and the intestinal microbiota activity will be pivotal to improve the food-based promotion of health and well being. The project aims at studying how the omnivore, vegetarian and vegan diets may affect the oral intake of microorganims, and the composition of the oral and fecal microbiota. With the aim to build up a permanent European platform for such type of studies, ten Research Units (RUs) are involved in the proposal, with the partnership of 16 National and, especially, foreign Institutions, covering 12 different countries. About 50 omnivore, vegetarian and vegan volunteers, for a total of 150 subjects will be recruited. Volunteers will be asked to fill in diaries, describing their dietary habits, and to collect biological samples (saliva, feces and urine), once a week for three weeks. For obvious ethical constraints, biopsies will be not available in this study. RUs will share their tasks, mainly depending on the nature of the samples to be studied, namely foods and biological samples. Based on the different dietary habits, the presumptive intake of microorganims will be estimated using literature data and, especially, culture-dependent methods. Typing and antibiotic resistance of some food related microbial communities or foods will be also investigated. The microbial diversity of foods, whose microbiota has never been studied in depth, will be characterized by PCR-DGGE and deep sequencing. The metabolome characterization will complete the overview on foods. After collecting and preparing biological samples from the three diet groups, the oral and fecal microbiota will be studied. The viable cell number of several microbial groups will be estimated in fecal samples, before freezing. Preliminarily, the microbial diversity of saliva and fecal ecosystems will be analyzed through PCR-DGGE. PCR assessment of genetic basis of antibiotic resistance will be also carried out. Selected numbers of biological samples will be further subjected to next generation sequencing, aiming at determining representative individuals/samples of the three types of diet. Only for feces, representative samples (e.g., 4/5 for each diet) will be subjected to meta-omics analyses based on meta-genomic, meta-transcriptomic and meta-proteomic approaches. An integrated and iterative workflow will be also developed, by assembling an in house synthetic meta-genome. The functionality of fecal samples and/or of isolates from feces will be characterized based on fecal genotoxic and anti-genotoxic activities, and modulation of the immune response. In agreement with an holistic approach, the metabolome analysis of saliva, feces and urine will complete the characterization of biological samples. All data available from the different RUs will merge into a common database, whose structure will be developed during the project. Based on the literature data (ISI Web of Knowledge), this is the first study that aims at correlating the effect of the main dietary habits on the oral and fecal microbiota through integrated meta-omics analyses.

Condition or disease Intervention/treatment
Diet and Human Microbiota Other: Omnivore, vegetarian and vegan subjects.

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Target Follow-Up Duration: 3 Weeks
Official Title: Microorganisms in Foods and in Humans: Study of the Microbiota and the Related Metabolome as Affected by Omnivore, Vegetarian or Vegan Diets
Study Start Date : January 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Omnivore, vegetarian and vegan subjects.
These subjecs followed the diet from at least two years.
Other: Omnivore, vegetarian and vegan subjects.
Omnivore, vegetarian and vegan subjects collected the feces, urina and saliva samples for 3 weeks from recruiting.

Outcome Measures

Primary Outcome Measures :
  1. Quantitative determination of microrganisms (cell density:Log CFU/g) in food and in biological samples (saliva, feces and urina) through culture independent approach on different selective culture media. [ Time Frame: For 3 weeks from recruiting ]
    Omnivore, vegetarian and vegan subjects followed the specific diet from at least two years.

Secondary Outcome Measures :
  1. Global analysis of microbial diversity (rarefaction maximum predicted (RFM), Chao and Shannon diversity index) from food and biological samples, and integrated meta-omics (metagenomics, metatranscriptomics, metaproteomics, metabolomics). [ Time Frame: For 3 weeks from recruiting. ]

Other Outcome Measures:
  1. Genotoxicity (Comet assay) and residual genotoxic activity of the compounds (SOS-Chromotest) from samples of fecal water (FW). [ Time Frame: For 3 weeks from recruiting. ]

Biospecimen Retention:   Samples With DNA
Feces, urine and saliva samples

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study focused on enrolling of 150 healthy volunteers including an equal number of omnivores, vegetarians and vegans (age 18-59 years, male/female ratio ca. 1:1). Recruited volunteers will be asked to sign a consensus document, to record their dietary habits and to collect biological samples (saliva, feces and urine).

Inclusion Criteria:

  • Age (18 - 59 years).
  • BMI (18.5-24.9 kg/m2).
  • No usual intake of drugs and dietary supplements / pharmacological pre-and probiotics.
  • No taking antibiotics in the last three months.
  • Absence of intestinal (Crohn's disease, ulcerative colitis, bacterial contamination syndrome, constipation, celiac disease, irritable bowel disease) and metabolic (diabetes type 1 and type 2, cardiovascular and neurovascular diseases, cancer, neurodegenerative diseases, rheumatoid arthritis, allergies) diseases.
  • No pregnancy and breast-feeding.

Exclusion Criteria:

  • Inability to give the informed consent.
Contacts and Locations

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): NCT02118857

Contact: Marco Gobbetti, Professor 00390805442949 ext 0039 marco.gobbetti@uniba.it

Università di Bari Recruiting
Bari, Italy, 70126
Contact: Marco Gobbetti, Professor    00390805442948 ext 0039    marco.gobbetti@uniba.it   
Principal Investigator: Marco Gobbetti, Professor         
Università di Bari Recruiting
Bari, Italy, 70126
Contact: Maria De Angelis, Professor    00390805442946 ext 0039    maria.deangelis@uniba.it   
Sub-Investigator: Gianluigi Cardinali, Prof         
Sub-Investigator: Danilo Ercolini, Prof         
Sub-Investigator: Erasmo Neviani, Prof         
Sub-Investigator: Aldo Corsetti, Prof         
Sub-Investigator: Patrizia Brigidi, Prof         
Sub-Investigator: Francesca Clementi         
Sub-Investigator: Luca Simone Cocolin, Prof         
Sub-Investigator: Mauro Rossi, Dr         
Sub-Investigator: Lucia Vannini, Dr         
Principal Investigator: Marco Gobbetti, Prof         
Sponsors and Collaborators
University of Bari
University Of Perugia
Federico II University
University of Parma
University of Teramo
University of Bologna
Università Politecnica delle Marche
University of Turin, Italy
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Study Chair: Marco Gobbetti, Professor University of Bari
More Information

Responsible Party: Marco Gobbetti, Full professor, University of Bari
ClinicalTrials.gov Identifier: NCT02118857     History of Changes
Other Study ID Numbers: PRIN-2014-GB
MG160102 ( Registry Identifier: MARCO GOBBETTI )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014

Keywords provided by Marco Gobbetti, University of Bari:
Microorganisms and foods
Fecal microbiota
Salivary microbiota