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Is it safe to prescribe antibiotics at the commonly administered dose for patients with stomach reduction surgery? Study of available concentration of oral amoxicillin

Is it safe to prescribe antibiotics in tablets dosage form for bariatric patients? Oral bioavailability study of amoxicillin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3dgcpv
Enrollment
Unknown
Registered
2016-12-05
Start date
2017-01-09
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

Nutritional and metabolic diseases, Obesity, Bariatric Surgery.

Interventions

Will be selected 40 patients, aged between 18 and 55 years. The recruitment of the research subjects will be by multimedia, posters and direct contact with gastric surgeons of Maringa and region, for
Drug
Behavioural
Q45.070
G03.787.151

Sponsors

Núcleo de Pesquisa Clínica e Bioequivalência
Lead Sponsor
Universidade Estadual de Maringá (UEM)
Collaborator

Eligibility

Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Health volunteers who have undergone bariatric surgery by the technique Roux in Y gastric band at least 3 months ago; To be over 18 years or under 55 years old; Has signed the Written Informed Consent Form.

Exclusion criteria

Exclusion criteria: Intolerance or hypersensitivity to Amoxicillin; Renal or hepatic faillure; Pregnancy; Brest-Feeding; Alcohol or illicit drugs user; Use of prokinetic drug (metoclopramide, erythromycin or domperidone); Enrollment at Clinical Study in the last 3 months; Show thrombocytopenia, anemia; Bariatric patients by others techniques then Roux in Y gastric band; Be under 18 or over 55 years old; Bariatric surgery over 5 years ago; Bariatric surgery for less than 3 months.

Design outcomes

Primary

MeasureTime frame
Statistically significant difference (p <0.05) in the pharmacokinetic parameters between the group that received suspension versus tablet, which will be calculated from the concentration curve versus time.

Secondary

MeasureTime frame
Statistically significant difference (p <0.05) in the pharmacokinetic parameters only between the group that received suspension versus tablet.

Countries

Brazil

Contacts

Public ContactElza Grimshaw

Núcleo de Pesquisa Clínica e Bioequivalência

ekimura@uem.br+55(44)3011-9201

Outcome results

None listed

Source: REBEC (via WHO ICTRP)