NCT01501305

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

1 year

First QC Date

December 26, 2011

Last Update Submit

December 28, 2011

Conditions

Diarrhea

Keywords

influencecarob powderprobioticsduration

Outcome Measures

Primary Outcomes (1)

  • Reduction in diarrhea

    Measurement of number of vomiting and diarrhea bowel movements before and after intervention

    One week

Secondary Outcomes (1)

  • Number of days until no diarrhea bowel movements

    1 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Mineral rehydration solution

Dietary Supplement: Mineral solution

Carob powder

ACTIVE COMPARATOR

Carob powder and probiotics

Dietary Supplement: Carob powder with probiotics

Interventions

Mineral solutionDIETARY_SUPPLEMENT

Rehydration mineral solution

Placebo
Carob powder with probioticsDIETARY_SUPPLEMENT

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

Carob powder

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Acute diarrhea

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Jamal Garah, MD

CONTACT

972-4-6304333

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2011

First Posted

December 29, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations

IL(1)