NL-OMON44814
Completed
Not Applicable
The role of the intestinal microbiome in enteric and systemic vaccine immune responses - Rota-biome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- vaccin immunogeniciteit
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 63
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •\* Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination and laboratory tests carried out within 28 days prior to starting antibiotics (day \-9\). A subject with a clinical abnormality or laboratory parameter outside the reference range may be included if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- •\* Male between 18 and 35 years of age, inclusive at the time of signing the informed consent
- •\* Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
- •\* Normal defecation pattern (defined as \*3x/ day and \*3x/week)
Exclusion Criteria
- •\* Baseline anti\-rotavirus immunglobluin A level greater than 20 IU/mL or equivalent geometric mean titer.
- •\* Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavorable for enrollment, including inflammatory diseases.
- •\* Subject with any history of immunodeficiency
- •Subject with a history of thrombocytopenia or bleeding disorder
- •\* Subjects with a history of any type of malignancy
- •\* Subject has a past or current gastrointestinal disease which may influence the gut microbiota
- •\* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- •\* History of alcoholism and/or drinking more than an average of 5 units of alcohol per day
- •\* The subject has received an investigational product within three months of day 0 of the current study
- •\* Use of prescription or non\-prescription drugs and herbal and dietary supplements within 6 months unless in the opinion of the investigator the medication will not interfere with the study procedures or compromise subject safety
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
The role of intestinal bacteria in obese patients with cardiovascular risk (metabolic syndrome)obesitydiabetesmetabolic syndromeC18.452.394.968.500.570RBR-2fm8j9Faculdade de Medicina da Universidade São Paulo
Not yet recruiting
Not Applicable
Het effect van antibiotica en de darmflora op afweerreactiesEndotoxemiaNL-OMON27487Academic Medical Centre, Amsterdam16
Completed
Not Applicable
The role of intestinal microbiota composition and intestinal permeability in the development of (complicated) diverticular disease.Outpocketings of colonic mucosa10013535NL-OMON35377Medisch Universitair Ziekenhuis Maastricht210
Completed
Not Applicable
The influence of the intestinal microbiome on the development of postoperative complications after elective colon surgery - a prospective cohort studyK91.83T79.3Post-traumatic wound infection, not elsewhere classifiedDRKS00014059niversitätsklinikum FreiburgInstitut für Umweltmedizin und KrankenhaushygieneUni-Zentrum Naturheilkunde127
Not yet recruiting
Not Applicable
The role of the gut microbiome in the pathogenesis of IgA nephropathyNL-OMON49937Radboud Universitair Medisch Centrum150