A Phase 1 interventional study of BB-12 supplemented strawberry yogurt and Strawberry flavored yogurt in Children, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 1 Year to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Georgetown University · Phase 1, Interventional, and Other
The investigators believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be more appealing to both children and their parents for long term consumption than pharmaceutical-like preparations. In addition to the benefits associated with the consumption of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense food.
More specifically, the rationale for this Phase I study is to determine safety of this yogurt drink and comply with FDA recommendations pertaining to an Investigational New Drug application. The investigators hypothesize that BB-12 is safe in generally healthy children ages 1-5 years.
Probiotics are live microorganisms that, when administered in sufficient amounts, may improve health. A common use for probiotics is in addressing gastrointestinal issues, such as antibiotic-associated diarrhea (AAD). As an alternative to supplements, probiotics are also included as ingredients in fermented dairy products to produce functional foods, which are foods providing health benefits beyond their nutritional value. Yogurt, for example, is a fermented milk product often considered a functional food. One of the most commonly used probiotics is Bifidobacterium animalis ssp. lactis (BB-12).
Our Primary Aim in Years 1-2 is to conduct a pediatric randomized controlled study to establish the safety of BB-12 fortified yogurt in children. Our Secondary Aims are to examine the fecal microbiota of children prior to, during and following consumption of probiotics. This study will evaluate whether a well-defined, probiotic-containing yogurt can safely be used as an effective delivery vehicle for probiotics. This study is important to help advance probiotic research forward in a systematic, well-accepted manner. Our long-term goal is to create yogurt with sufficient probiotic dosages to positively impact many different aspects of childhood and adult health.
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.
Inclusion criteria for parents/caregivers are:
Inclusion criteria for children are:
Exclusion Criteria:
Parents/caregivers will also be asked to refrain from giving their child any probiotic foods or supplements during the entire 2 weeks of the active intervention period, and 2 weeks before day 1 of starting the yogurt. Parents will be supplied with a list of products to avoid.
Probiotic, Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12), supplemented strawberry yogurt, 4 ounces taken orally for 10 days
Drug: BB-12 supplemented strawberry yogurt
Placebo, strawberry yogurt, 4 ounces taken orally for 10 days
Other: Strawberry flavored yogurt
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
Placebo, strawberry yogurt, 4 ounces taken orally for 10 days
Number of Adverse Events
The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.
Time frame: Days 0-180
Overall Composition of the Gut Microbiota
Relative abundance of operational taxonomic units (OTU) classified at the phylum level
Time frame: 90 days
| Milestone | BB-12 | Control |
|---|---|---|
| Started | 31 | 31 |
| Completed | 29 | 31 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.
| Number of AE reported | BB-12® | Control |
|---|---|---|
| During intervention (day 0-10) | 61 | 35 |
| Post-intervention (day 11-180) | 52 | 38 |
Relative abundance of operational taxonomic units (OTU) classified at the phylum level
| relative abundance (%) | BB-12 | Control |
|---|---|---|
| Firmicutes | 71.7 | 74.1 |
| Bacteroidetes | 14.7 | 11.6 |
| Actinobacteria | 11.1 | 11.9 |
| Proteobacteria | 1.6 | 1.4 |
| Verrucomicrobia | 0.7 | 1.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BB-12® | — | 3/29 (10.3%) | 22/29 (75.9%) |
| Control | — | 0/31 (0%) | 22/31 (71%) |
| Event | BB-12® | Control |
|---|---|---|
| FeverGeneral disorders | 1/29 | 0/31 |
| bronchiolitisRespiratory, thoracic and mediastinal disorders | 1/29 | 0/31 |
| pneumoniaRespiratory, thoracic and mediastinal disorders | 1/29 | 0/31 |
| Event | BB-12® | Control |
|---|---|---|
| Runny noseGeneral disorders | 17/29 | 10/31 |
| OtherGeneral disorders | 5/29 | 12/31 |
| Age, Categorical(Participants) | BB-12® | Control | Total |
|---|---|---|---|
| <=18 years | 29 | 31 | 60 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | BB-12® | Control | Total |
|---|---|---|---|
| Female | 13 | 18 | 31 |
| Male | 16 | 13 | 29 |
| Ethnicity (NIH/OMB)(Participants) | BB-12® | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 8 |
| Not Hispanic or Latino | 26 | 26 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BB-12® | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 21 | 17 | 38 |
| More than one race | 1 | 6 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Child Attends Daycare(Participants) | BB-12® | Control | Total |
|---|---|---|---|
| Yes | 20 | 17 | 37 |
| No | 9 | 14 | 23 |
| Parent's Marital Status(Participants) | BB-12® | Control | Total |
|---|---|---|---|
| Married/Living with partner | 26 | 28 | 54 |
| Single | 3 | 1 | 4 |
| Divorced | 0 | 2 | 2 |
| Total Household Income(Participants) | BB-12® | Control | Total |
|---|---|---|---|
| $15,000-$30,000 | 2 | 1 | 3 |
| $30,001-$75,000 | 6 | 10 | 16 |
| $75,001-$100,000 | 6 | 6 | 12 |
| $100,001-$150,000 | 8 | 8 | 16 |
| >$150,000 | 6 | 6 | 12 |
| No response | 1 | 0 | 1 |
| Smoker in Household-Yes(Participants) | BB-12® | Control | Total |
|---|---|---|---|
| Count of participants | 0 | 3 | 3 |
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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