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

NCT ID: NCT01491659

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

Brief Summary

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

Detailed Description

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Conditions

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Diarrhoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Amoxicillin/clavulanate/Idoform Plus

Group Type ACTIVE_COMPARATOR

Idoform Plus

Intervention Type DIETARY_SUPPLEMENT

orally once daily

Amoxicillin/clavulanate/Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

orally once daily

Interventions

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Idoform Plus

orally once daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

orally once daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danisco/Dupont

UNKNOWN

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Countries

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Denmark

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4141002&StudyName=A%20Study%20to%20Evaluate%20the%20Effect%20and%20Safety%20of%20Idoform%20Plus%20on%20Bowel%20Side%20Effects%20in%20Healthy%20Subjects%20Treated%20With%20Amoxicillin/%20Clavul

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

Other Identifiers

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B4141002

Identifier Type: -

Identifier Source: org_study_id