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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

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ClinicalTrials.gov Identifier: NCT01491659
Recruitment Status : Withdrawn
First Posted : December 14, 2011
Last Update Posted : September 24, 2013
Sponsor:
Collaborator:
Danisco/Dupont
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Diarrhoea Dietary Supplement: Idoform Plus Dietary Supplement: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2013
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Amoxicillin/clavulanate/Idoform Plus Dietary Supplement: Idoform Plus
orally once daily
Placebo Comparator: Amoxicillin/clavulanate/Placebo Dietary Supplement: Placebo
orally once daily



Primary Outcome Measures :
  1. Occurence of Antibiotic Associated Diarrhea [ Time Frame: 17 days ]

Secondary Outcome Measures :
  1. Duration of Antibiotic Associated Diarrhoea [ Time Frame: 17 days ]
  2. 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 ]
  3. Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom [ Time Frame: 17 days ]
  4. Changes in the Gut Microbiota Composition [ Time Frame: 17 days ]
  5. Changes in Markers of Antibiotic Resistance [ Time Frame: 17 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491659


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01491659     History of Changes
Other Study ID Numbers: B4141002
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013

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