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

This study is not yet open for participant recruitment.

Verified April 2013 by Pfizer

Sponsor:

Collaborator:

Danisco/Dupont

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01491659

First received: December 5, 2011

Last updated: April 10, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 5, 2011

Last Updated Date

April 10, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Occurence of Antibiotic Associated Diarrhea [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

antibiotic associated diarrhoea [ Time Frame: 17 days ] [ Designated as safety issue: No ]

The primary objective of the study is to estimate the effect of Idoform Plus compared to placebo during a 10 days treatment with amoxicillin / clavulanate on:

• Incidence of antibiotic-associated diarrhoea (3 or more loose stools per day)

Change History

Complete list of historical versions of study NCT01491659 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of Antibiotic Associated Diarrhoea [ Time Frame: 17 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Changes in the Gut Microbiota Composition [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Changes in Markers of Antibiotic Resistance [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Estimate the effect of Idoform Plus compared to placebo on duration of antibiotic-associated diarrhoea [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Estimate the effect of Idoform Plus compared to placebo on changes in feces consistency [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Estimate the effect of Idoform Plus compared to placebo on changes in gastrointestinal symptoms (pain/stomach cramps; bloating/distension; nausea/upset stomach) [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Estimate the effect of Idoform Plus compared to placebo on changes in microbiotic composition [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Estimate the effect of Idoform Plus compared to placebo on changes in markers of antibiotic resistance [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Diarrhoea

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Amoxicillin/clavulanate/Idoform Plus
Intervention: Dietary Supplement: Idoform Plus
Placebo Comparator: Amoxicillin/clavulanate/Placebo
Intervention: Dietary Supplement: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

April 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01491659

Other Study ID Numbers ^ICMJE

B4141002

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Danisco/Dupont

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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