Status:
WITHDRAWN
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Danisco/Dupont
Conditions:
Diarrhoea
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics
Eligibility Criteria
Inclusion
- Healthy volunteers 18-70 years of age
- Subjects with normal gastrointestinal function
- Subjects willing to provide written informed consent
Exclusion
- 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
- Subjects using proton pump inhibitors
- Subjects using H2 antagonists
- Subjects using antacids frequently
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01491659
Start Date
January 1 2013
End Date
March 1 2013
Last Update
September 24 2013
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