Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 10359 for:    Anti-Infective Agents AND Bacterial

Study of Human Microbiota in Healthy and Pathological Conditions (MicroSP)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03460392
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Brief Summary:

The aim of the present study is to characterize the bacterial composition (microbiota) colonizing to the human body in different physio - pathological conditions (lifestyle, motor activity, surgical operations, probiotic and prebiotic consumption, antibiotic therapies, chemotherapeutic therapies), nervous and musculoskeletal diseases, gastrointestinal and metabolic disorders , oral and vaginal diseases, etc.). In particular, they will be investigate:

  • the changes in the bacterial abundance
  • the potential microbial interactions with the human host
  • the microbial networks describing on the bacterial interactions within a specific composition of the human microbiota

Condition or disease Intervention/treatment
Microbial Colonization Drug: Antibiotic therapy

Detailed Description:

The main objective of this study is to deepen the knowledge about the bacterial communities associated to the human organism. In particular, the present study aims to evaluate how the microbiota (intestinal, cutaneous, vaginal, nasal, bronchial, breast milk, salivary, oral, etc.) is subject to quantitative and qualitative changes consequently to different events involving the human host. The project trys to highlight which microorganisms may be involved in the onset or progression of certain pathological condition, as well as to identify which bacterial genera can be more subject to variations due to specific non-pathological events.

Secondary objectives of this study are:

  • To define a "healthy microbiome", that is to understand which are the main bacteria that commonly compose the human microbiome in physiological conditions, differentiating it from that present in certain pathological conditions.
  • To characterize the physiological effects that bacterial changes of the human microbiota have on the host.
  • To evaluate whether the use of probiotics, prebiotics, dietary and nutritional factors, cosmetics, and oral, nasal, vaginal, or pharmacological therapies of any kind can influence the microbial network of the human microbiota associated to different body districts.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Study of Human Microbiota in Healthy and Pathological Conditions
Actual Study Start Date : June 12, 2017
Actual Primary Completion Date : July 31, 2017
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Neurological and behavioral disorders
Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled.
Drug: Antibiotic therapy
To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time;
Other Name: Probiotics, dietary factors, cosmetics and adjuvants

Subjects affected by bone diseases
Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled.
Drug: Antibiotic therapy
To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time;
Other Name: Probiotics, dietary factors, cosmetics and adjuvants

Dysmetabolic and/or endocrine disorders
Patients with endocrine disorders, such as thyroid disfunctions, or with metabolic disorders, including diabetes mellitus,are enrolled.
Subjects performing agonistic activity
Subjects performing physical activity at agonistic level are enrolled.
Gastroenteric disorders
Subjects affected by gastric and/or enteric disorders are enrolled.
Prolonged antibiotic therapy
Patients subjected to prolonged antibiotic therapies and undergone a variety of surgical procedures are enrolled.
Drug: Antibiotic therapy
To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time;
Other Name: Probiotics, dietary factors, cosmetics and adjuvants

Healthy subjects
Subjects without any known ongoing disease are enrolled.



Primary Outcome Measures :
  1. Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count [ Time Frame: Up to 24 weeks ]
    It is a measure of the bacterial amount


Secondary Outcome Measures :
  1. Chao's indices estimated on the total OTU amount [ Time Frame: Up to 24 weeks ]
    It is a measure of bacterial diversity

  2. Simpson's index (D) estimated on the total OTU amount [ Time Frame: Up to 24 weeks ]
    It is a measure of bacterial diversity

  3. Shannon's index estimated on the total OTU amount [ Time Frame: Up to 24 weeks ]
    It is a measure of bacterial diversity

  4. The OTU abundances will be used to calculate an adjacency matrix based on the Spearman's correlation coefficient (rs) among different bacterial genus [ Time Frame: up to 24 weeks ]
    It is a measure of strength of linear association between different bacterial genera


Biospecimen Retention:   Samples With DNA
  • Stool samples;
  • bone and tissue biopsies;
  • tissues samples.


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

For each cohoort 15 healthy subjects will be enrolled (controls), for a total of 90 subjects.

The study involves the recruitment of 180 subjects (90 pathological and 90 healthy and recruited

Criteria

Inclusion Criteria:

  • subjects suffering from neurological/behavioral diseases;
  • subjects suffering of bone diseases;
  • subjects affected of dysmetabolic / or endocrine disorders;
  • subjects with physical activities at a competitive level;
  • subjects affected of gastrointestinal disorders;
  • subjects with prolonged antibiotic therapies and undergoing surgery

Exclusion Criteria:

  • no use of probiotics in the month prior the sampling;
  • no use of antibiotics in the month prior the sampling;
  • no consumption of yogurt in the month prior the sampling;

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): NCT03460392


Locations
Layout table for location information
Italy
IRCCS Istituto Ortopedico Galeazzi
Milan, MI, Italy, 20161
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
Layout table for investigator information
Principal Investigator: Lorenzo Drago, Prof. IRCCS Galeazzi Orthopedic Institute, Milan, Italy

Additional Information:

Layout table for additonal information
Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03460392     History of Changes
Other Study ID Numbers: MiscoSP
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: February 2018

Keywords provided by Istituto Ortopedico Galeazzi:
Human microbiota

Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents