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Effect of intestinal imbalance on the defense cells of the body

Investigation of the effect of Gut Dysbiosis on histone post-translational modifications in neutrophils

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8c2qyhj
Enrollment
Unknown
Registered
2022-03-24
Start date
2021-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis

Interventions

Oral antibiotic therapy will be performed for 3 days with neomycin 500 mg/3 times a day, metronidazole 500 mg/3 times a day and vancomycin 125 mg/4 times a day. Antibiotics-treated subjects (10 subjec

Sponsors

Instituto de Biologia - Universidade Estadual de Campinas
Lead Sponsor
Instituto de Biologia - Universidade Estadual de Campinas
Collaborator

Eligibility

Sex/Gender
Male
Age
20 Years to 29 Years

Inclusion criteria

Inclusion criteria: Male, volunteer subjects; age between 20 and 29 years; eutrophic (Body Mass Index between 18.5 and 29.9); non smokers; in good general health.

Exclusion criteria

Exclusion criteria: Recent (up to 60 days before treatment) history of: antibiotic or corticosteroid therapy; vaccination; continuous drug therapy. Diagnosis or clinical signs of: metabolic diseases; acute or chronic inflammatory diseases ; autoimmune diseases; allergy or atopy; cancer; digestive system diseases; acute or chronic infectious disease known to impair general health or immune responses (for examples: HIV infection, hepatitis C, influenza, acute herpes simplex); depression, hypochondria, or other psychiatric illnesses that may lead to risky behaviors. Not mentioned conditions that may interfere with the study will follow medical advice regarding exclusion or permanency in the study.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the list of differentially expressed genes (DEG) in in vitro stimulated or unstimulated neutrophils from treated and untreated subjects. Such gene list is obtained by transcriptome sequencing (RNAseq) followed by bioinformatics data analysis and statistical treatment.

Secondary

MeasureTime frame
Oral administration of antibiotics to healthy subjects is expected to promote temporary disruption of the gut microbiota (dysbiosis). Such an outcome will be evaluated by identifying the amount and type of microorganism found in stool samples (by 16S rRNA). Stool samples will be obtained from antibiotics-treated subjects (before and after treatment), or not treated.

Countries

Brazil

Contacts

Public ContactMarco Vinolo

Universidade Estadual de Campinas - UNICAMP

mvinolo@gmail.com+55 19 3521-6570

Outcome results

None listed

Source: REBEC (via WHO ICTRP)