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NCT01501305 Clinical Trial

Influence of Carob and Probiotics on Acute Diarrhea in Children

Diarrhea Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01501305
Other study ID # 68-2010
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received December 26, 2011
Last updated December 28, 2011
Start date January 2012
Est. completion date February 2013

Study information
Verified date December 2011
Source Hillel Yaffe Medical Center
Contact Jamal Garah, MD
Phone 972-4-6304333
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date February 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

- Acute diarrhea

Exclusion Criteria:

- Dehydration

- Chronic diseases

- Chronic diarrhea (more than 2 weeks)

- Septic shock

- Hypovolemia

- On medication

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Mineral solution
Rehydration mineral solution
• Carob powder with probiotics
7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in diarrhea Measurement of number of vomiting and diarrhea bowel movements before and after intervention One week No
Secondary Number of days until no diarrhea bowel movements Measurement of number of days until diarrhea is gone 1 week No
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