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Influence of Carob and Probiotics on Acute Diarrhea in Children

This study is not yet open for participant recruitment.
Verified December 2011 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01501305
First received: December 26, 2011
Last updated: December 28, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Diarrhea
 Dietary Supplement: Mineral solution
Dietary Supplement: Carob powder with probiotics
 Phase 1
Phase 2

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

Resource links provided by NLM:

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

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Reduction in diarrhea [ Time Frame: One week ] [ Designated as safety issue: No ]
    Measurement of number of vomiting and diarrhea bowel movements before and after intervention


Secondary Outcome Measures:
  • Number of days until no diarrhea bowel movements [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measurement of number of days until diarrhea is gone


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute diarrhea

Exclusion Criteria:

  • Dehydration
  • Chronic diseases
  • Chronic diarrhea (more than 2 weeks)
  • Septic shock
  • Hypovolemia
  • On medication
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501305

Contacts
Contact: Jamal Garah, MD 972-4-6304333

Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01501305     History of Changes
Other Study ID Numbers: 68-2010
Study First Received: December 26, 2011
Last Updated: December 28, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
influence
carob powder
probiotics
duration

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Locust bean gum
 Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013