A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
Phase 4
Withdrawn
- Conditions
- Diarrhoea
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Idoform Plus
- Registration Number
- NCT01491659
- Lead Sponsor
- Pfizer
- Brief Summary
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amoxicillin/clavulanate/Placebo Placebo - Amoxicillin/clavulanate/Idoform Plus Idoform Plus -
- Primary Outcome Measures
Name Time Method Occurence of Antibiotic Associated Diarrhea 17 days
- Secondary Outcome Measures
Name Time Method Duration of Antibiotic Associated Diarrhoea 17 days Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day 17 days Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom 17 days Changes in the Gut Microbiota Composition 17 days Changes in Markers of Antibiotic Resistance 17 days