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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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diarrhoea
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy volunteers 18-70 years of age

- Subjects with normal gastrointestinal function

- Subjects willing to provide written informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01491659
Pfizer
Withdrawn
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate

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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
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
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Diarrhoea
  • Dietary Supplement: Idoform Plus
    orally once daily
  • Dietary Supplement: Placebo
    orally once daily
  • Active Comparator: Amoxicillin/clavulanate/Idoform Plus
    Intervention: Dietary Supplement: Idoform Plus
  • Placebo Comparator: Amoxicillin/clavulanate/Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Denmark
 
NCT01491659
B4141002
No
Not Provided
Not Provided
Pfizer
Pfizer
Danisco/Dupont
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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