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

Pfizer

Status and phase: Withdrawn; Phase 4

Conditions: Diarrhoea

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Idoform Plus

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01491659

B4141002

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Amoxicillin/clavulanate/Idoform Plus

Active Comparator group

Treatment:

Dietary Supplement: Idoform Plus

Amoxicillin/clavulanate/Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo