Diarrhoea
Conditions
Brief summary
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics
Interventions
DIETARY_SUPPLEMENTIdoform Plus
orally once daily
DIETARY_SUPPLEMENTPlacebo
orally once daily
Sponsors
Danisco/Dupont
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurence of Antibiotic Associated Diarrhea | 17 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed