Blastocystis Hominis InfectionsPhase 4NCT01521403
Is it Effective to Treat Patients With Blastocystis Hominis Infection?
A Phase 4 study testing Metronidazole in people with Blastocystis Hominis Infections, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blastocystis Hominis Infections
- What is being tested?
- Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2012to 30 Dec 2022
- Phase
- Phase 4
- 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
- ≥ 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
Who cannot join
- Fever > 37.5°
- bloody diarrhoea
- weight loss > 10% of usual body weight
- significant decrease of general condition
- oncological diseases
- immune deficiencies
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland
Lausanne, Canton of Vaud, 1011
About this study
Official title: Is it Effective to Treat Patients With Blastocystis Hominis Infection? A Double-blind Placebo Controlled Randomized Trial
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.
Read the detailed description
Prevalence of B. hominis is between 30-50% in developing countries. Many travellers visit developing countries and are therefore at risk to be infected by this parasite. It's frequent that travellers return from developing countries with gastro-intestinal symptoms and approximately 10% of them have B. hominis as the sole parasite identified in the stools. Some anti-infective drugs, including metronidazole, trimethoprim-sulfamethoxazole and nitazoxanide, have shown to have activity against B. hominis, but there is still controversy about the pathogenic potential of B. hominis and there is no consensus about the indications for treatment.
It is hypothesised that metronidazole is more effective than placebo in returning travellers with gastrointestinal symptoms and B. hominis as the sole intestinal parasite identified in the stool.
- Conditions
- Blastocystis Hominis Infections
- Being tested
- Metronidazole, Placebo
- Keywords
- Blastocystis hominis, Metronidazole
- Medical subject headings
- Blastocystis Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
3x500 mg/day for 10 days
PlaceboDrug
3x1 tablet per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Active comparator | Metronidazole 3x500 mg per day for 10 days Receives: Drug: Metronidazole |
| Placebo | Placebo comparator | Placebo 3x1 tablet per day for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10-14 days after treatment with Metronidazol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startNov 2012
- Primary completion31 Dec 2018
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastocystis Hominis InfectionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge de Valliere, University of Lausanne Hospitals
- Investigators
- Serge de Valliere, MD, MSc, Principal investigator, Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521403
- Sponsor's protocol ID
- CVMV-Blastocystis hominis
- Status last verified
- Aug 2022
- First submitted
- 25 Jan 2012
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Effective to Treat Patients With Blastocystis Hominis Infection? A Double-blind Placebo Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT01521403
- Acronym / sponsor ID
- CVMV-Blastocystis hominis
- Conditions
- Blastocystis Hominis Infections
- Keywords
- Blastocystis hominis, Metronidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 30 Jan 2012 (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.
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.
Detailed description
Prevalence of B. hominis is between 30-50% in developing countries. Many travellers visit developing countries and are therefore at risk to be infected by this parasite. It's frequent that travellers return from developing countries with gastro-intestinal symptoms and approximately 10% of them have B. hominis as the sole parasite identified in the stools. Some anti-infective drugs, including metronidazole, trimethoprim-sulfamethoxazole and nitazoxanide, have shown to have activity against B. hominis, but there is still controversy about the pathogenic potential of B. hominis and there is no consensus about the indications for treatment.
It is hypothesised that metronidazole is more effective than placebo in returning travellers with gastrointestinal symptoms and B. hominis as the sole intestinal parasite identified in the stool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Active comparator | Drug: MetronidazoleMetronidazole 3x500 mg per day for 10 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 3x1 tablet per day for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- Fever > 37.5°
- bloody diarrhoea
- weight loss > 10% of usual body weight
- significant decrease of general condition
- oncological diseases
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 |
|---|---|---|
| Metronidazole3x500 mg/day for 10 days | Drug | Metronidazole |
| Placebo3x1 tablet per day for 10 days | Drug | Placebo |
Primary outcome
Improvement of gastro-intestinal symptoms
Time frame: 10-14 days after treatment with Metronidazol
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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.
Serge de Valliere, MD, MSc principal investigator
Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole in people with Blastocystis Hominis Infections, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 4 inclusion and 10 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of gastro-intestinal symptoms (time frame: 10-14 days after treatment with Metronidazol). 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 23 Aug 2022.