Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Dr. Philipp Zanger, MD MSc DTM258 enrolled

Overview

The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

258

Conditions

Diarrhoea

Interventions

RifaximinDRUG

400 mg per day, oral use, maximum duration 28 days

LactoseDRUG

Coated Tablet, Oral Use

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ≥ 18 and \< 65 years * Good general condition (according to history and clinical examination) * Written informed consent * No pregnancy * No breast feeding * Efficacious contraception (e.g. oral, double-barrier) during the study and 4 weeks after termination of the study * No participation in other clinical trials 4 weeks before, during participation, and 4 weeks after participation in this study * Planned travel period between 6 and 28 days * Planned travel to South- and Southeast Asia * Planned time to arrival in South- or Southeast Asia ≤ 24 hours Exclusion Criteria: * Pregnancy * Breast feeding * Age \< 18 and ≥ 65 years * No written informed consent * Chronic gastrointestinal disease and/ or immune insufficiency * Low general condition (according to history and clinical examination) * Regular medication with gastrointestinal side-effects and/or immunosuppressive medication * Participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study * No efficacious contraception * Planned travel period \< 6 and \> 28 days * Planned travel outside South- and Southeast Asia * Vaccination against cholera using DUKORAL within 12 months prior to inclusion * Planned time to arrival in South- or Southeast Asia \> 24 hours * Known hypersensitivity against rifaximin or rifamycin-derivatives in general * Known lactose intolerance

Locations (1)

Institute of Tropical Medicine, University Hospital of Tübingen

Tübingen, Germany

Outcomes

Primary Outcomes

Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection.

Time frame: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany

Secondary Outcomes

Documentation of adverse effects and tolerance of prophylaxis with rifaximin.

Time frame: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany

Evaluation of prevention of post infectious irritable bowel syndrome.

Time frame: From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany

Data from ClinicalTrials.gov

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