Influence of Carob and Probiotics on Acute Diarrhea in Children

December 28, 2011 updated by: Hillel Yaffe Medical Center
Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute diarrhea

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in diarrhea
Time Frame: One week
Measurement of number of vomiting and diarrhea bowel movements before and after intervention
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days until no diarrhea bowel movements
Time Frame: 1 week
Measurement of number of days until diarrhea is gone
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

December 26, 2011

First Submitted That Met QC Criteria

December 28, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 28, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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