NCT01491659

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

2 months

First QC Date

December 5, 2011

Last Update Submit

September 23, 2013

Conditions

Diarrhoea

Outcome Measures

Primary Outcomes (1)

  • Occurence of Antibiotic Associated Diarrhea

    17 days

Secondary Outcomes (5)

  • 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

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

    17 days

  • Changes in the Gut Microbiota Composition

    17 days

  • Changes in Markers of Antibiotic Resistance

    17 days

Study Arms (2)

Amoxicillin/clavulanate/Idoform Plus

ACTIVE COMPARATOR
Dietary Supplement: Idoform Plus

Amoxicillin/clavulanate/Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Idoform PlusDIETARY_SUPPLEMENT

orally once daily

Amoxicillin/clavulanate/Idoform Plus
PlaceboDIETARY_SUPPLEMENT

orally once daily

Amoxicillin/clavulanate/Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers 18-70 years of age
  • Subjects with normal gastrointestinal function
  • Subjects willing to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 14, 2011

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 24, 2013

Record last verified: 2013-09