DiarrheaPhase 1/2NCT01501305
Influence of Carob and Probiotics on Acute Diarrhea in Children
A Phase 1/2 study testing Mineral solution and Carob powder with probiotics in people with Diarrhea, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- Mineral solution and Carob powder with probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Feb 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acute diarrhea
Who cannot join
- Dehydration
- Chronic diseases
- Chronic diarrhea (more than 2 weeks)
- Septic shock
- Hypovolemia
- On medication
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Jamal Garah, MD contact
About this study
Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.
- Conditions
- Diarrhea
- Being tested
- Mineral solution, Carob powder with probiotics
- Keywords
- influence, carob powder, probiotics, duration
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral solutionDietary supplement
Rehydration mineral solution
Carob powder with probioticsDietary supplement
7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Mineral rehydration solution Receives: Dietary Supplement: Mineral solution |
| Carob powder | Active comparator | Carob powder and probiotics Receives: Dietary Supplement: Carob powder with probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in diarrhea
Measurement of number of vomiting and diarrhea bowel movements before and after intervention
Measured: One week
Secondary outcomes (1)
Number of days until no diarrhea bowel movements
Measurement of number of days until diarrhea is gone
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501305
- Sponsor's protocol ID
- 68-2010
- Status last verified
- Dec 2011
- First submitted
- 26 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Carob and Probiotics on Acute Diarrhea in Children
- ClinicalTrials.gov ID
- NCT01501305
- Acronym / sponsor ID
- 68-2010
- Conditions
- Diarrhea
- Keywords
- influence, carob powder, probiotics, duration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Mineral solutionMineral rehydration solution |
| Carob powder | Active comparator | Dietary Supplement: Carob powder with probioticsCarob powder and probiotics |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Acute diarrhea
Key exclusion criteria (7 listed)
- Dehydration
- Chronic diseases
- Chronic diarrhea (more than 2 weeks)
- Septic shock
- Hypovolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mineral solutionRehydration mineral solution | Dietary supplement | Placebo |
| Carob powder with probiotics7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone | Dietary supplement | Carob powder |
Primary outcome
Reduction in diarrhea
Time frame: One week
Measurement of number of vomiting and diarrhea bowel movements before and after intervention
1 secondary outcome
Number of days until no diarrhea bowel movements
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamal Garah, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mineral solution and Carob powder with probiotics in people with Diarrhea, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamal Garah, MD (972-4-6304333), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in diarrhea (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.