NCT01521403

Brief Summary

The objective of this study is to determine whether in the setting of primary health care it is effective to treat with metronidazole returning travellers with gastrointestinal symptoms and B. hominis in the stool or not.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

6.2 years

First QC Date

January 25, 2012

Last Update Submit

August 22, 2022

Conditions

Blastocystis Hominis Infections

Keywords

Blastocystis hominisMetronidazole

Outcome Measures

Primary Outcomes (1)

  • Improvement of gastro-intestinal symptoms

    The improvement of the following symptoms will be evaluated: * Presence of unusually soft or unformed stools in the last 3 days (yes or no) * Average number of stools per day in the last 3 days * Maximal abdominal pain in the last 3 days on a scale from 0-10 * Bloating in last 3 days on a scale from 0-10 * Flatulence in last 3 days on a scale from 0-10

    10-14 days after treatment with Metronidazol

Study Arms (2)

Metronidazole

ACTIVE COMPARATOR

Metronidazole 3x500 mg per day for 10 days

Drug: Metronidazole

Placebo

PLACEBO COMPARATOR

Placebo 3x1 tablet per day for 10 days

Drug: Placebo

Interventions

MetronidazoleDRUG

3x500 mg/day for 10 days

Metronidazole
PlaceboDRUG

3x1 tablet per day for 10 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years
  • Gastrointestinal symptoms for more than 10 days
  • B. hominis in any quantity in at least one stool specimen out of 3 examined
  • No other pathogenic micro-organism identified

You may not qualify if:

  • Fever \> 37.5°
  • bloody diarrhoea
  • weight loss \> 10% of usual body weight
  • significant decrease of general condition
  • oncological diseases
  • immune deficiencies
  • known chronic intestinal diseases
  • use of anti-protozoan drugs in the last 2 weeks
  • use of anti-coagulant treatment or antabuse
  • pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Blastocystis Infections

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsAmebiasisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Serge de Valliere, MD, MSc

    Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, Consultant, Principal Investigator

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 30, 2012

Study Start

November 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 30, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)