DiarrhoeaPhase 4NCT01491659
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
A Phase 4 study testing Idoform Plus in people with Diarrhoea, run by Pfizer.
Trial summary
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhoea
- What is being tested?
- Idoform Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2013
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers 18-70 years of age
- Subjects with normal gastrointestinal function
- Subjects willing to provide written informed consent
Who cannot join
- Subjects receiving antibiotic treatment within three months prior to inclusion in the study
- Pregnancy or planned pregnancy
- Breast feeding
- Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or its components
- Subjects with known renal insufficiency
- Subjects using products containing probiotics, fibers and/or prebiotics
Show all 9Show fewer
- Subjects using proton pump inhibitors
- Subjects using H2 antagonists
- Subjects using antacids frequently
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics
- Conditions
- Diarrhoea
- Being tested
- Idoform Plus, Placebo
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idoform PlusDietary supplement
orally once daily
PlaceboDietary supplement
orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin/clavulanate/Idoform Plus | Active comparator | Not described Receives: Dietary Supplement: Idoform Plus |
| Amoxicillin/clavulanate/Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Antibiotic Associated Diarrhea
Measured: 17 days
Secondary outcomes (5)
Duration of Antibiotic Associated Diarrhoea
Measured: 17 days
Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day
Measured: 17 days
Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom
Measured: 17 days
Changes in the Gut Microbiota Composition
Measured: 17 days
Changes in Markers of Antibiotic Resistance
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startJan 2013
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrhoeaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Danisco/Dupont
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491659
- Sponsor's protocol ID
- B4141002
- Status last verified
- Sep 2013
- First submitted
- 5 Dec 2011
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
- ClinicalTrials.gov ID
- NCT01491659
- Acronym / sponsor ID
- B4141002
- Conditions
- Diarrhoea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Danisco/Dupont
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 14 Dec 2011 (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.
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin/clavulanate/Idoform Plus | Active comparator | Dietary Supplement: Idoform Plus |
| Amoxicillin/clavulanate/Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers 18-70 years of age
- Subjects with normal gastrointestinal function
- Subjects willing to provide written informed consent
Key exclusion criteria (9 listed)
- Subjects receiving antibiotic treatment within three months prior to inclusion in the study
- Pregnancy or planned pregnancy
- Breast feeding
- Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or its components
- Subjects with known renal insufficiency
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 |
|---|---|---|
| Idoform Plusorally once daily | Dietary supplement | Amoxicillin/clavulanate/Idoform Plus |
| Placeboorally once daily | Dietary supplement | Amoxicillin/clavulanate/Placebo |
Primary outcome
Occurence of Antibiotic Associated Diarrhea
Time frame: 17 days
5 secondary outcomes
Duration of Antibiotic Associated Diarrhoea
Time frame: 17 days
Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day
Time frame: 17 days
Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom
Time frame: 17 days
Changes in the Gut Microbiota Composition
Time frame: 17 days
Changes in Markers of Antibiotic Resistance
Time frame: 17 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Idoform Plus in people with Diarrhoea, run by Pfizer.
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 9 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: withdrawn, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Occurence of Antibiotic Associated Diarrhea (time frame: 17 days). 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 24 Sep 2013.