Antibiotic-Associated DiarrheaPhase 3WGAADNCT00826137
Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics
A Phase 3 study testing Inulin and fructo-oligosaccharides. in people with Antibiotic-Associated Diarrhea, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Antibiotic-Associated Diarrhea
- What is being tested?
- Inulin and fructo-oligosaccharides.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Jul 2010
- Phase
- Phase 3
- 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 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children with acute infection.
Who cannot join
- Hypersensitivity to antibiotics, chronic illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children
Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.
Read the detailed description
Group will get either the product or placebo blindly throughout antibiotic treatment with additional 14 days.
- Conditions
- Antibiotic-Associated Diarrhea
- Being tested
- Inulin and fructo-oligosaccharides., Placebo
- Keywords
- prebiotics, Antibiotic-associated diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin and fructo-oligosaccharides.Dietary supplement
Also called Placebo is base powder of product with no oligosaccharides.
Supplement during antibiotic treatment+14 days.
PlaceboDietary supplement
Placebo is base powder of product with no oligosaccharides.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Treated with prebiotics. Receives: Dietary Supplement: Inulin and fructo-oligosaccharides. |
| B | Placebo comparator | Placebo treated. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of diarrhea.
Measured: During antibiotic treatment+14 days
Secondary outcomes (1)
Duration of diarrhea.
Measured: During antibiotic treatment+14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-Associated 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zvi Weizman, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826137
- Sponsor's protocol ID
- Sor472908ctil
- Acronym
- WGAAD
- Status last verified
- Jun 2012
- First submitted
- 29 Dec 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children
- ClinicalTrials.gov ID
- NCT00826137
- Acronym / sponsor ID
- WGAAD / Sor472908ctil
- Conditions
- Antibiotic-Associated Diarrhea
- Keywords
- prebiotics, Antibiotic-associated diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Jan 2009 (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.
Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.
Detailed description
Group will get either the product or placebo blindly throughout antibiotic treatment with additional 14 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Inulin and fructo-oligosaccharides.Treated with prebiotics. |
| B | Placebo comparator | Dietary Supplement: PlaceboPlacebo treated. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children with acute infection.
Key exclusion criteria (1 listed)
- Hypersensitivity to antibiotics, chronic illness.
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 |
|---|---|---|
| Inulin and fructo-oligosaccharides.Also: Placebo is base powder of product with no oligosaccharides.Supplement during antibiotic treatment+14 days. | Dietary supplement | A |
| PlaceboPlacebo is base powder of product with no oligosaccharides. | Dietary supplement | B |
Primary outcome
Prevention of diarrhea.
Time frame: During antibiotic treatment+14 days
1 secondary outcome
Duration of diarrhea.
Time frame: During antibiotic treatment+14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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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.
Zvi Weizman, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inulin and fructo-oligosaccharides. in people with Antibiotic-Associated Diarrhea, run by Soroka University 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 1 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: finished, as of the sponsor's last update on 14 Jun 2012. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of diarrhea. (time frame: During antibiotic treatment+14 days). 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 14 Jun 2012.