Study of Human Microbiota in Healthy and Pathological Conditions

NCT03460392 | Unknown

• 1 other identifier: MiscoSP
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Microbial Colonization

Keywords

Human microbiota

Outcome Measures

Primary Outcomes (1)

• Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count

  It is a measure of the bacterial amount

  Up to 24 weeks

Secondary Outcomes (4)

• Chao's indices estimated on the total OTU amount

  Up to 24 weeks

• Simpson's index (D) estimated on the total OTU amount

  Up to 24 weeks

• Shannon's index estimated on the total OTU amount

  Up to 24 weeks

• The OTU abundances will be used to calculate an adjacency matrix based on the Spearman's correlation coefficient (rs) among different bacterial genus

  up to 24 weeks

Study Arms (7)

Neurological and behavioral disorders

Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled.

Drug: Antibiotic therapy

Subjects affected by bone diseases

Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled.

Drug: Antibiotic therapy

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

Healthy subjects

Subjects without any known ongoing disease are enrolled.

Interventions

Antibiotic therapy DRUG

To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time;

Also known as: Probiotics, dietary factors, cosmetics and adjuvants

Neurological and behavioral disorders; Prolonged antibiotic therapy; Subjects affected by bone diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, MI, 20161, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Stool samples; * bone and tissue biopsies; * tissues samples.

MeSH Terms

Conditions

Communicable Diseases

Interventions

Anti-Infective Agents; Probiotics; Cosmetics

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Specialty Uses of Chemicals; Household Products; Technology, Industry, and Agriculture

Study Officials

• Lorenzo Drago, Prof.

  IRCCS Galeazzi Orthopedic Institute, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 9, 2018
• Study Start: June 12, 2017
• Primary Completion: July 31, 2017
• Study Completion: December 31, 2019
• Last Updated: March 9, 2018

Record last verified: 2018-02

Locations

IT (1)