Skip to content

Paromomicin and cotrimoxazol versus metronidazol in the eradication of Blastocystis hominis in patients with gastrointestinal symptoms.

Controlled, randomized trial, comparing the efficacy of paromomicin and cotrimoxazol versus metronidazol in the eradication of Blastocystis hominis in patients with gastrointestinal symptoms.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-004414-28-ES
Enrollment
Unknown
Registered
2015-03-27
Start date
2015-06-10
Completion date
Unknown
Last updated
2015-08-24

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

Conditions

Gastrointestinal symptoms by Blastocystis hominis

Interventions

Trade Name: Metronidazol Product Name: metronidazol Product Code: D06BX01 Pharmaceutical Form: Tablet Trade Name: Setrin Forte Product Name: Septrin Forte Product Code: DB00916 Pharmaceutical Form: T

Sponsors

Hospital Universitari Mutua Terrassa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age > 18 years, gastrointestinal clinic symptoms of at least 1 month of duration, positive Blastocystis hominis in faeces. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Other gastrointestinales diseases, allergy to medicines of the study, pregnancy, breastfeeding, antibiotic ingestion in the last month.

Design outcomes

Primary

MeasureTime frame
Main Objective: To analyze the efficacy of the paramomicin and cotrimoxazol in comparison with metronidazol in the eradication of Blastocystis hominis in simptomatic patients.;Secondary Objective: There is not a secondary objective;Primary end point(s): Confirmation of the eradication of the Blastocystis hominis by intention to treat after 4 weeks of finalized treatment, through the determination of negative faeces parasites in 3 samples.;Timepoint(s) of evaluation of this end point: 40 days

Secondary

MeasureTime frame
Secondary end point(s): Clinical response and therapeutic compliance;Timepoint(s) of evaluation of this end point: Clinical response at 10 days and 40 days

Countries

Spain

Contacts

Public ContactNuria Giménez-Gómez

Hospita Universitari Mutua Terrassa

ngimenez@mutuaterrassa.es349373650503918

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026