Influence of Carob and Probiotics on Acute Diarrhea in Children
December 28, 2011 updated by: Hillel Yaffe Medical Center
Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute diarrhea
Exclusion Criteria:
- Dehydration
- Chronic diseases
- Chronic diarrhea (more than 2 weeks)
- Septic shock
- Hypovolemia
- On medication
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Mineral rehydration solution
|
Rehydration mineral solution
|
|
Active Comparator: Carob powder
Carob powder and probiotics
|
7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in diarrhea
Time Frame: One week
|
Measurement of number of vomiting and diarrhea bowel movements before and after intervention
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of days until no diarrhea bowel movements
Time Frame: 1 week
|
Measurement of number of days until diarrhea is gone
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
February 1, 2013
Study Registration Dates
First Submitted
December 26, 2011
First Submitted That Met QC Criteria
December 28, 2011
First Posted (Estimate)
December 29, 2011
Study Record Updates
Last Update Posted (Estimate)
December 29, 2011
Last Update Submitted That Met QC Criteria
December 28, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 68-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.