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Influence of Carob and Probiotics on Acute Diarrhea in Children

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ClinicalTrials.gov Identifier: NCT01501305
Recruitment Status : Unknown
Verified December 2011 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 29, 2011
Last Update Posted : December 29, 2011
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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

Condition or disease Intervention/treatment Phase
Diarrhea Dietary Supplement: Mineral solution Dietary Supplement: Carob powder with probiotics Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Minerals
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Mineral rehydration solution
Dietary Supplement: Mineral solution
Rehydration mineral solution
Active Comparator: Carob powder
Carob powder and probiotics
Dietary Supplement: Carob powder with probiotics
7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone

Primary Outcome Measures :
  1. Reduction in diarrhea [ Time Frame: One week ]
    Measurement of number of vomiting and diarrhea bowel movements before and after intervention

Secondary Outcome Measures :
  1. Number of days until no diarrhea bowel movements [ Time Frame: 1 week ]
    Measurement of number of days until diarrhea is gone

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute diarrhea

Exclusion Criteria:

  • Dehydration
  • Chronic diseases
  • Chronic diarrhea (more than 2 weeks)
  • Septic shock
  • Hypovolemia
  • On medication
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501305

Contact: Jamal Garah, MD 972-4-6304333

Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01501305     History of Changes
Other Study ID Numbers: 68-2010
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Hillel Yaffe Medical Center:
carob powder

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Pharmaceutical Solutions
Locust bean gum
Gastrointestinal Agents