Antibiotic-associated DiarrheaPhase 2PLAY ONNCT03181516
Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
A Phase 2 study testing Bifidobacterium animalis subsp. lactis BB-12 in people with Antibiotic-associated Diarrhea, run by Georgetown University at 1 site in United States.
Trial summary
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Bifidobacterium animalis subsp. lactis BB-12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2017to 11 Oct 2023
- Phase
- Phase 2
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is between ages of 3-12 years
- Caregiver has the ability to read, speak and write English or Spanish
- Household has refrigerator for proper storage of drink
- Household has telephone access
- Enrollment must take place within 24 hours of starting antibiotics
- Child was outpatient treated
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- Child was prescribed treatment with a penicillin or cephalosporin class antibiotic regimen for 7-10 days for a respiratory infection;
- The following is a list (non-exhaustive) of inclusive antibiotics:
- Amoxicillin
- Augmentin (amoxicillin/clavulanate)
- Ancef (cefazolin)
- Cefadroxil
- Cephalexin
- Cephradine
- Duricef (cefadroxil)
- Keflex (cephalexin)
- Kefzol (cefazolin)
- Velosef (cephradine)
- Ceclor (cefaclor)
- Cefotan
- Cefoxitin
- Ceftin (cefuroxime)
- Cefzil (cefprozil)
- Lorabid (loracarbef)
- Mefoxin (Cefoxitin)
- Zinacef (cefuroxime)
- Omnicef (cefdinir)
- Suprax (cefixime)
- Dicloxacillin
- Pen-Vee K (penicillin)
Who cannot join
- Developmental delays
- Any chronic condition, such as diabetes or asthma, that requires medication
- Prematurity, or born prior to 37 weeks gestation/of pregnancy
- Congenital anomalies
- Failure to thrive
- Allergy to strawberry
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- Active diarrhea (diarrhea is defined in this study as three or more loose stools per day for two consecutive days)
- Any other medicines used except anti-pyretic medicines (pro re nata concomitant medications are allowed)
- Parental belief of lactose intolerance
- History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
- History of gastrointestinal surgery or disease
- Milk-protein allergy
- Allergy to any component of the product or the yogurt vehicle
- Allergy or a hypersensitivity to the antibiotic prescribed by her/his provider
- Allergy to any of the following medications:
- Tetracycline
- Erythromycin
- Trimethoprim
- Ciprofloxacin
- blood oxygen saturation is less than 90% (if enrollment/baseline visit is completed in person and if the participant was prescribed antibiotics during a telemedicine visit)
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Department of Family Medicine, Research Division
Washington D.C., District of Columbia, 20007
About this study
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products used for AAD are not supported by rigorous independent research, and often results in non-evidence-based usage. The overarching objective is to move research forward for the most well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented with BB-12, and to carry out longitudinal community structure and gene expression analysis of fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population receiving antibiotics. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD.
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- Bifidobacterium animalis subsp. lactis BB-12, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animalis subsp. lactis BB-12Biological
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
ControlOther
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
| Study group | Role | What they receive |
|---|---|---|
| BB-12 | Experimental | Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt Receives: Biological: Bifidobacterium animalis subsp. lactis BB-12 |
| Control | Placebo comparator | Yogurt without Bifidobacterium animalis subsp. lactis BB-12 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Diarrhea
Diarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea.
Measured: 14 days
Adverse Events
Number of reported adverse events over the duration of the study
Measured: Days 0-180
Secondary outcomes (2)
Pediatric Quality-of-life Score
The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory.
Based on the PedsQL form filled out by participants, the scores were translated using the PedsQL form guidelines: 0=100, 1=75, 2=50,3=25,4=0. The raw scores of participants were averaged after translation. The lowest possible score is 0 and the highest possible score is 100. A higher score indicates a healthier lifestyle.
Measured: 7 days
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
This will be a dichotomous (yes or no) outcome of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start30 Sep 2017
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, University of Maryland, Baltimore
- Responsible party
- Principal investigator, Daniel Merenstein, Georgetown University
- Investigators
- Daniel Merenstein, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181516
- Sponsor's protocol ID
- 2016-1489
- Acronym
- PLAY ON
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2017
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No