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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Danisco/Dupont
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01491659
First received: December 5, 2011
Last updated: September 23, 2013
Last verified: September 2013
  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:


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 ]

Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 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

Sponsors and Collaborators
Pfizer
Danisco/Dupont
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: September 23, 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 April 14, 2014