Prospective, randomised, placebo controlled, double blind monocenter trial for the prophylactic treatment of diarrhoea with rifaximin for travellers to South- and Southeast-Asia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003986-42-DE

Enrollment

258

Registered

2007-10-19

Start date

2008-06-18

Completion date

Unknown

Last updated

2013-06-17

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

Conditions

diarrhoea of travellers to South- and Southeast-Asia MedDRA version: 12.0 Level: LLT Classification code 10021907 Term: Infectious diarrhea

Interventions

Trade Name: Normix Pharmaceutical Form: Coated tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621814 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults = 18 und =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy - Breast feeding - Age 28 days - Travel outside South- and Southeast Asia - Vaccination against cholera using DUKORAL within 12 months prior to inclusion - Time to arrival in the country > 24 hours - nown hypersensitvity against rifaximin or rifamycine-derivatives in general

Design outcomes

Primary

Measure	Time frame
Main Objective: efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea;Secondary Objective: toxicity of rifaximin, prevention of post infectious irritable bowel syndrome;Primary end point(s): Efficacy of the prevention of traveller´s diarhoea (by measurement of frequency and consistence of the stool as well as other gastrointestial complaints) with rifaximin Toxicity of rifaximin	—

Measure

Time frame

Main Objective: efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea;Secondary Objective: toxicity of rifaximin, prevention of post infectious irritable bowel syndrome;Primary end point(s): Efficacy of the prevention of traveller´s diarhoea (by measurement of frequency and consistence of the stool as well as other gastrointestial complaints) with rifaximin Toxicity of rifaximin

—

Countries

Germany

Outcome results

None listed

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