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

Diarrhoea Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01491659
• Other study ID #: B4141002
• Status: Withdrawn
• Phase: Phase 4
• First received: December 5, 2011
• Last updated: September 23, 2013
• Start date: January 2013
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhoea

Intervention

Dietary Supplement:
• Idoform Plus
orally once daily
• Placebo
orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Danisco/Dupont

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of Antibiotic Associated Diarrhea		17 days	No
Secondary	Duration of Antibiotic Associated Diarrhoea		17 days	No
Secondary	Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day		17 days	No
Secondary	Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom		17 days	No
Secondary	Changes in the Gut Microbiota Composition		17 days	No
Secondary	Changes in Markers of Antibiotic Resistance		17 days	No

External Links

•   To obtain contact information for a study center near you, click here.