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WITHDRAWN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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