NCT01070277

Brief Summary

Study hypotheses is that Antiparasitic therapy in patients with chronic diarrhea after travel to a developing country, with a negative stool findings, will be significantly effective in eliminating diarrhea and other gastro-intestinal complaints compared to similar patients receiving placebo.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
2 years until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 27, 2014

Status Verified

August 1, 2014

Enrollment Period

3.8 years

First QC Date

February 15, 2010

Last Update Submit

August 26, 2014

Conditions

Chronic DiarrheaAbdominal PainBloating

Keywords

chronic diarrheatravelersParasitesalbendazoletinidazole

Outcome Measures

Primary Outcomes (1)

  • improvement in gastrointestinal complaints

    3 months

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days

Drug: Placebo control

Tinidazole and Albendazole treatment

EXPERIMENTAL

Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days

Drug: Tinidazole and Albendazole

Interventions

Tinidazole and AlbendazoleDRUG

Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days

Tinidazole and Albendazole treatment
Placebo controlDRUG

2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days

Placebo arm

Eligibility Criteria

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

You may qualify if:

  • Diarrhea (3 or more soft stools per day) for at least two weeks after a trip to a developing country in the past year
  • Stool sample negative for bacteria, parasites and helminthes at least once
  • Has not received, until now, antiparasitic or antihelminthic therapy

You may not qualify if:

  • Bloody diarrhea
  • Fever during enrolment 5. Allergy to the offered medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chaim Sheba Medical Center, Tel Hashomer, Israel

Ramat Gan, Israel

NOT YET RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Abdominal Pain

Interventions

TinidazoleAlbendazole

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbamatesAcids, AcyclicCarboxylic AcidsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, The Center of Geographic Medicine

Study Record Dates

First Submitted

February 15, 2010

First Posted

February 18, 2010

Study Start

March 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

August 27, 2014

Record last verified: 2014-08

Locations

IL(2)