Trial record 14 of 147 for:    Open Studies | "Minerals"

Influence of Carob and Probiotics on Acute Diarrhea in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmaceutical Solutions
Locust bean gum
Therapeutic Uses
Pharmacologic Actions
Antidiarrheals
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 28, 2014