Antibiotic-associated DiarrheaPhase 2/3NCT01143623
Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
A Phase 2/3 study testing Probiotic in people with Antibiotic-associated Diarrhea, run by Changhai Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD). Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jul 2011
- Phase
- Phase 2/3
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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 30-70 years
- initiating antibiotic therapy
- informed consent
Who cannot join
- current diarrhea
- life threatening illness
- habitual probiotic use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Response Effect of a Proprietary Probiotic Formula for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD).
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- Probiotic, Placebo
- Keywords
- antibiotic, diarrhea, probiotic
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
- acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day
ProbioticDietary supplement
- acidophilus, L. paracasei, B. lactis; 10 billion cfu capsule once per day
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Not described Receives: Dietary Supplement: Probiotic |
| Probiotic-2 | Active comparator | Not described Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of antibiotic-associated diarrhea
Measured: 5 weeks after antibiotic discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionJul 2011
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai DongLian, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143623
- Sponsor's protocol ID
- 09-SBC-2-DAN-03
- Status last verified
- Sep 2011
- First submitted
- 11 Jun 2010
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No