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Influence of Carob and Probiotics on Acute Diarrhea in Children

NCT ID: NCT01501305

Last Updated: 2011-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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Conditions

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Diarrhea

Keywords

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influence carob powder probiotics duration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Placebo

Mineral rehydration solution

Group Type PLACEBO_COMPARATOR

Mineral solution

Intervention Type DIETARY_SUPPLEMENT

Rehydration mineral solution

Carob powder

Carob powder and probiotics

Group Type ACTIVE_COMPARATOR

Carob powder with probiotics

Intervention Type DIETARY_SUPPLEMENT

7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone

Interventions

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Mineral solution

Rehydration mineral solution

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Acute diarrhea

Exclusion Criteria

* Dehydration
* Chronic diseases
* Chronic diarrhea (more than 2 weeks)
* Septic shock
* Hypovolemia
* On medication
* Pregnancy
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Jamal Garah, MD

Role: CONTACT

Phone: 972-4-6304333

Other Identifiers

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68-2010

Identifier Type: -

Identifier Source: org_study_id