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A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate

This study is not yet open for participant recruitment.
Verified April 2013 by Pfizer
Sponsor:
Collaborator:
Danisco/Dupont
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01491659
First received: December 5, 2011
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics


Condition Intervention Phase
Diarrhoea
 Dietary Supplement: Idoform Plus
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Diarrhea
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Occurence of Antibiotic Associated Diarrhea [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Antibiotic Associated Diarrhoea [ Time Frame: 17 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom [ Time Frame: 17 days ] [ Designated as safety issue: No ]
  • Changes in the Gut Microbiota Composition [ Time Frame: 17 days ] [ Designated as safety issue: No ]
  • Changes in Markers of Antibiotic Resistance [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amoxicillin/clavulanate/Idoform Plus Dietary Supplement: Idoform Plus
orally once daily
Placebo Comparator: Amoxicillin/clavulanate/Placebo Dietary Supplement: Placebo
orally once daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers 18-70 years of age
  • Subjects with normal gastrointestinal function
  • Subjects willing to provide written informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491659

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Denmark
Pfizer Investigational Site Not yet recruiting
Hoersholm, Denmark, DK-2970
Sponsors and Collaborators
Pfizer
Danisco/Dupont
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01491659     History of Changes
Other Study ID Numbers: B4141002
Study First Received: December 5, 2011
Last Updated: April 10, 2013
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013