CompletedNCT03181516PLAY ONUpdated Feb 21, 2025Results posted

Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics

A Phase 2 interventional study of Bifidobacterium animalis subsp. lactis BB-12 and Control in Antibiotic-associated Diarrhea, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by Georgetown University · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 255
Allocation: Randomized
Ages: 3 Years to 12 Years
Sex: All

Study 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). 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 studied

Antibiotic-associated Diarrhea

Browse trials for

Diarrhea 852

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 255 is above the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years to 12 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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
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)

Exclusion criteria

Exclusion Criteria:

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
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:
1. Tetracycline
2. Erythromycin
3. Trimethoprim
4. 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)

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 255 participants (actual)

Study arms

Experimental
BB-12
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Biological: Bifidobacterium animalis subsp. lactis BB-12
Placebo comparator
Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Other: Control

Interventions

BiologicalBifidobacterium animalis subsp. lactis BB-12
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
OtherControl
Yogurt without Bifidobacterium animalis subsp. lactis BB-12

What researchers measure

Primary outcomes

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.
Time frame: 14 days
Adverse Events
Number of reported adverse events over the duration of the study
Time frame: Days 0-180

Secondary outcomes

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.
Time frame: 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.
Time frame: 14 days

Results

Posted Feb 21, 2025

Participant flow

Participant flow — Overall Study
Milestone	BB-12	Control
Started	125	130
Completed	109	121
Not completed	16	9
Withdrew: Withdrawal by subject	14	7
Withdrew: Lost to follow-up	2	2

Outcome measures

PrimaryNumber 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.

Time frame:: 14 days
Reported as:: Count of participants · Participants

Number of Participants Experiencing Diarrhea
Participants	BB-12	Control
Yes	3	2
No	122	128

PrimaryAdverse Events

Number of reported adverse events over the duration of the study

Time frame:: Days 0-180
Reported as:: Number · AE events

Adverse Events
AE events	BB-12	Control
Adverse Events	144	148

SecondaryPediatric 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.

Time frame:: 7 days
Reported as:: Mean · score on a scale

Pediatric Quality-of-life Score
score on a scale	BB-12	Control
Pediatric Quality-of-life Score	85 ± 19	91 ± 10

SecondaryNumber 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.

Time frame:: 14 days
Reported as:: Number · Events

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.
Events	BB-12	Control
Loose stools	25	19
Constipation	15	21
Fever	11	14
Flatulence	6	4
Lack of Appetite	8	10
Pain	16	14
Rash	4	10
Vomiting	8	2
Cough	13	17
Earache	6	1
Nasal Congestion	14	12
Runny nose	10	9
Sore throat	5	13
Diarrhea	3	2

Adverse events

Collected over 180 Days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BB-12	0/125 (0%)	0/125 (0%)	64/125 (51.2%)
Control	0/130 (0%)	0/130 (0%)	69/130 (53.1%)

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	BB-12	Control
Loose StoolsGastrointestinal disorders	24/125	17/130
ConstipationGastrointestinal disorders	13/125	18/130
PainGeneral disorders	16/125	14/130
CoughRespiratory, thoracic and mediastinal disorders	12/125	16/130
Nasal CongestionRespiratory, thoracic and mediastinal disorders	13/125	12/130
FeverRespiratory, thoracic and mediastinal disorders	10/125	12/130
Sore ThroatRespiratory, thoracic and mediastinal disorders	5/125	11/130
Runny NoseRespiratory, thoracic and mediastinal disorders	10/125	9/130
Lack of AppetiteGastrointestinal disorders	7/125	10/130
RashGeneral disorders	4/125	9/130

Baseline characteristics

Age, Continuous
Age, Continuous(years)	BB-12	Control	Total
Mean	6.97 ± 2.71	6.44 ± 2.87	6.70 ± 2.80

Sex: Female, Male
Sex: Female, Male(Participants)	BB-12	Control	Total
Female	53	64	117
Male	65	62	127

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	BB-12	Control	Total
Hispanic or Latino	58	58	116
Not Hispanic or Latino	61	68	129
Unknown or Not Reported	6	4	10

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	BB-12	Control	Total
American Indian or Alaska Native	0	1	1
Asian	4	4	8
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	3	5
White	77	82	159
More than one race	19	17	36
Unknown or Not Reported	23	23	46

Region of Enrollment
Region of Enrollment(participants)	BB-12	Control	Total
United States	125	130	255

Health Insurance Status
Health Insurance Status(participants)	BB-12	Control	Total
Yes	110	123	233
No	10	4	14
Unknown	5	3	8

Smoking in the Household
Smoking in the Household(Participants)	BB-12	Control	Total
Yes	7	2	9
No	112	125	237
Unknown	6	3	9

Marital Status of Accompanying Guardian
Marital Status of Accompanying Guardian(Participants)	BB-12	Control	Total
Single	16	12	28
Married	82	92	174
Living with a Partner	13	6	19
Divorced	4	2	6
Separated	2	5	7
Widowed	0	1	1
Not reported/Unknown	8	12	20

1 further baseline measures are reported on the registry.

Study locations

1 site

Georgetown University Department of Family Medicine, Research Division
Washington, District of Columbia 20007, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jul 28, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03181516
Lead sponsor: Georgetown University
Collaborators: Penn State University, University of Maryland, Baltimore
Responsible party: Daniel Merenstein (Professor and Director of Research Programs, Georgetown University) — Principal investigator
First posted: Jun 8, 2017
Start date: Sep 30, 2017
Primary completion: Oct 11, 2023
Completion: Oct 11, 2023
Results posted: Feb 21, 2025
Last update: Feb 21, 2025

Study contacts

Daniel Merenstein, MD

principal investigator · Georgetown University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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