Chronic DiarrheaNCT01070277
Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea
A study testing Tinidazole and Albendazole in people with Chronic Diarrhea and Abdominal Pain, run by Sheba Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diarrhea, Abdominal Pain, Bloating
- What is being tested?
- Tinidazole and Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bloody diarrhea
- Fever during enrolment 5. Allergy to the offered medication
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Chaim Sheba Medical Center, Tel Hashomer, Israel
Ramat Gan
Eli Schwartz, MD, ++97235308456, elischwa@post.tau.ac.il
- Recruiting
Sheba Medical Center
Ramat Gan
Eli Schwartz, M.D, +972-35308456, Eli.schwartz@sheba.health.gov.il
About this study
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.
Read the detailed description
It is common to encounter travelers from developing countries who suffer from persistent diarrhea after returning home. In many cases repeated stool samples are negative for bacteria, parasites and helminthes and the cause of the diarrhea is not found.
The main debate is whether this condition is a persistent parasitic infection (unidentified) or post-infectious irritable bowel syndrome.However, clinical experience suggests that some of these travelers respond to antiparasitic therapy.
This study aims to answer the question whether antiparasitic treatment in these cases is beneficial.
- Conditions
- Chronic Diarrhea, Abdominal Pain, Bloating
- Being tested
- Tinidazole and Albendazole, Placebo control
- Keywords
- chronic diarrhea, travelers, Parasites, albendazole, tinidazole
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinidazole and AlbendazoleDrug
Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days
Placebo controlDrug
2 placebo pills X2 /day for 2 days followed by
1 placebo Pill X2 / day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm | Placebo comparator | 2 placebo pills X2 /day for 2 days followed by
1 placebo Pill X2 / day for 7 days Receives: Drug: Placebo control |
| Tinidazole and Albendazole treatment | Experimental | Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days Receives: Drug: Tinidazole and Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in gastrointestinal complaints
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startMar 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiarrheaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070277
- Sponsor's protocol ID
- SHEBA-08-5059-ES-CTIL
- Status last verified
- Aug 2014
- First submitted
- 15 Feb 2010
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea
- ClinicalTrials.gov ID
- NCT01070277
- Acronym / sponsor ID
- SHEBA-08-5059-ES-CTIL
- Conditions
- Chronic Diarrhea, Abdominal Pain, Bloating
- Keywords
- chronic diarrhea, travelers, Parasites, albendazole, tinidazole
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is common to encounter travelers from developing countries who suffer from persistent diarrhea after returning home. In many cases repeated stool samples are negative for bacteria, parasites and helminthes and the cause of the diarrhea is not found.
The main debate is whether this condition is a persistent parasitic infection (unidentified) or post-infectious irritable bowel syndrome.However, clinical experience suggests that some of these travelers respond to antiparasitic therapy.
This study aims to answer the question whether antiparasitic treatment in these cases is beneficial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo arm | Placebo comparator | Drug: Placebo control2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days |
| Tinidazole and Albendazole treatment | Experimental | Drug: Tinidazole and AlbendazoleTinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Bloody diarrhea
- Fever during enrolment 5. Allergy to the offered medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinidazole and AlbendazoleTinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days | Drug | Tinidazole and Albendazole treatment |
| Placebo control2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days | Drug | Placebo arm |
Primary outcome
improvement in gastrointestinal complaints
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaim Sheba Medical Center, Tel Hashomer, Israel
Ramat Gan, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tinidazole and Albendazole in people with Chronic Diarrhea and Abdominal Pain, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in gastrointestinal complaints (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2014.