Back to resultsInfluence of Carob and Probiotics on Acute Diarrhea in Children
Primary Purpose
Diarrhea
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Mineral solution
Carob powder with probiotics
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring influence, carob powder, probiotics, duration
Eligibility Criteria
Inclusion Criteria:
- Acute diarrhea
Exclusion Criteria:
- Dehydration
- Chronic diseases
- Chronic diarrhea (more than 2 weeks)
- Septic shock
- Hypovolemia
- On medication
- Pregnancy
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Carob powder
Arm Description
Mineral rehydration solution
Carob powder and probiotics
Outcomes
Primary Outcome Measures
Reduction in diarrhea
Measurement of number of vomiting and diarrhea bowel movements before and after intervention
Secondary Outcome Measures
Number of days until no diarrhea bowel movements
Measurement of number of days until diarrhea is gone
Full Information
NCT ID
NCT01501305
First Posted
December 26, 2011
Last Updated
December 28, 2011
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01501305
Brief Title
Influence of Carob and Probiotics on Acute Diarrhea in Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
influence, carob powder, probiotics, duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Mineral rehydration solution
Arm Title
Carob powder
Arm Type
Active Comparator
Arm Description
Carob powder and probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Mineral solution
Intervention Description
Rehydration mineral solution
Intervention Type
Dietary Supplement
Intervention Name(s)
Carob powder with probiotics
Intervention Description
7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone
Primary Outcome Measure Information:
Title
Reduction in diarrhea
Description
Measurement of number of vomiting and diarrhea bowel movements before and after intervention
Time Frame
One week
Secondary Outcome Measure Information:
Title
Number of days until no diarrhea bowel movements
Description
Measurement of number of days until diarrhea is gone
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute diarrhea
Exclusion Criteria:
Dehydration
Chronic diseases
Chronic diarrhea (more than 2 weeks)
Septic shock
Hypovolemia
On medication
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamal Garah, MD
Phone
972-4-6304333
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
12. IPD Sharing Statement
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Influence of Carob and Probiotics on Acute Diarrhea in Children
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