Back to results

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

Primary Purpose

Diarrhoea

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Idoform Plus

Placebo

About this trial

This is an interventional prevention trial for Diarrhoea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Amoxicillin/clavulanate/Idoform Plus

Amoxicillin/clavulanate/Placebo

Arm Description

Outcomes

Primary Outcome Measures

Occurence of Antibiotic Associated Diarrhea

Secondary Outcome Measures

Duration of Antibiotic Associated Diarrhoea

Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day

Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom

Changes in the Gut Microbiota Composition

Changes in Markers of Antibiotic Resistance

Full Information

NCT ID

NCT01491659

First Posted

December 5, 2011

Last Updated

September 23, 2013

Sponsor

Pfizer

Collaborators

Danisco/Dupont

1. Study Identification

Unique Protocol Identification Number

NCT01491659

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Withdrawn

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

Danisco/Dupont

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhoea

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amoxicillin/clavulanate/Idoform Plus

Arm Type

Active Comparator

Arm Title

Amoxicillin/clavulanate/Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Idoform Plus

Intervention Description

orally once daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

orally once daily

Primary Outcome Measure Information:

Title

Occurence of Antibiotic Associated Diarrhea

Time Frame

17 days

Secondary Outcome Measure Information:

Title

Duration of Antibiotic Associated Diarrhoea

Time Frame

17 days

Title

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

Title

Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom

Time Frame

17 days

Title

Changes in the Gut Microbiota Composition

Time Frame

17 days

Title

Changes in Markers of Antibiotic Resistance

Time Frame

17 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

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

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs