A Study to Evaluate the Effect and Safety of Idoform Plus... | NCT01491659

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

NCT01491659

Sponsor

Pfizer

Status

Withdrawn

Last Update Posted

Sep 24, 2013Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Diarrhoea

Interventions

Idoform Plus
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Dec 5, 2011

First Submission Date that Met QC Criteria

Dec 13, 2011

First Posted Date

Dec 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2013

Last Update Posted Date

Sep 24, 2013Estimated

Name	Class
Danisco/Dupont	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amoxicillin/clavulanate/Idoform Plus	Active Comparator		Dietary Supplement: Idoform Plus
Amoxicillin/clavulanate/Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Idoform Plus	Dietary Supplement	orally once daily	Amoxicillin/clavulanate/Idoform Plus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurence of Antibiotic Associated Diarrhea		17 days

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms