Adults on AntibioticsPhase 1PHASENCT00848003
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics
A Phase 1 study testing Bifidobacterium animalis subsp. lactis strain BB-12 in people with Adults on Antibiotics, run by Georgetown University at 1 site in United States.
Trial summary
We 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adults on Antibiotics
- What is being tested?
- Bifidobacterium animalis subsp. lactis strain BB-12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2011
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to speak and write English or Spanish
- Refrigerator for proper storage of drink
- Telephone access
- Enrollment must take place within 24 hours of starting antibiotics
- Treatment with a penicillin class antibiotic regimen for 10 days for an upper respiratory infection;
- The following is a list of inclusive antibiotics:
Show all 30Show fewer
- 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)
- Antibiotic prescribed at least twice a day
- Outpatients
Who cannot join
- Chronic conditions, such as diabetes or asthma, that require daily medication
- Allergy to strawberry
- Active diarrhea
- Allergy to penicillin class antibiotic
- Any other medicines used except prescribed antibiotic and anti-pyretic medicines
- Allergy to any of the following medications
Show all 12Show fewer
- Tetracycline
- Erythromycin
- Trimethoprim
- Ciprofloxacin
- Lactose intolerance.
- During baseline physical exam, any of the following will be grounds for exclusion; systolic blood pressure>140, systolic blood pressure <90, diastolic >90, oxygen saturation <98%, pulse rate >100, pulse rate <55 and respiratory rate >17. These include all vital signs that fall outside of the "normal" range, including Grade 1 through Grade 4.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
We 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 our drink and comply with the FDA's recommendations pertaining to an IND application, we will conduct a phase I safety study.
We hypothesize that BB-12 is safe in healthy adults ages 18 and over.
- Conditions
- Adults on Antibiotics
- Being tested
- Bifidobacterium animalis subsp. lactis strain BB-12, Placebo
- Keywords
- Probiotics, BB-12, Yogurt, Antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animalis subsp. lactis strain BB-12Drug
Also called BB-12 probiotic supplemented yogurt
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
PlaceboDrug
Also called Strawberry flavored yogurt
Strawberry flavored yogurt
| Study group | Role | What they receive |
|---|---|---|
| 1. Active | Active comparator | Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12)
Probiotic, BB-12, supplemented yogurt, 4 ounces taken orally for 10 days Receives: Drug: Bifidobacterium animalis subsp. lactis strain BB-12 |
| 2. Placebo | Placebo comparator | Strawberry flavored yogurt Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics.
Measured: 1 year
Secondary outcomes (1)
In addition to safety diary, participants will keep a daily diary to track number of bowel movements, if drink was consumed, if illness resulted in change in activity, over-the-counter medicines used and other illness symptoms.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (102)Papers the sponsor has linked to this study.
- Other trials for Adults on AntibioticsStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Principal investigator, Daniel Merenstein, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848003
- Sponsor's protocol ID
- R21AT003600-01A1
- Other IDs
- IND # 13691
- Acronym
- PHASE
- Status last verified
- May 2013
- First submitted
- 18 Feb 2009
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heath and Nutritional Properties of Probiotics in Food Including Powder Milk With Live Lactic Acid Bacteria: Food and Agriculture Organization of the United Nations and World Health Organization2005; 2001.
Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
PubMed 11297958Lin HC, Su BH, Chen AC, Lin TW, Tsai CH, Yeh TF, Oh W. Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants. Pediatrics. 2005 Jan;115(1):1-4. doi: 10.1542/peds.2004-1463.
PubMed 15629973Mastrandrea F, Coradduzza G, Serio G, Minardi A, Manelli M, Ardito S, Muratore L. Probiotics reduce the CD34+ hemopoietic precursor cell increased traffic in allergic subjects. Eur Ann Allergy Clin Immunol. 2004 Apr;36(4):118-22.
PubMed 15180351Rosenfeldt V, Michaelsen KF, Jakobsen M, Larsen CN, Moller PL, Pedersen P, Tvede M, Weyrehter H, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in young children hospitalized with acute diarrhea. Pediatr Infect Dis J. 2002 May;21(5):411-6. doi: 10.1097/00006454-200205000-00012.
PubMed 12150178Vanderhoof JA, Whitney DB, Antonson DL, Hanner TL, Lupo JV, Young RJ. Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children. J Pediatr. 1999 Nov;135(5):564-8. doi: 10.1016/s0022-3476(99)70053-3.
PubMed 10547243Pelletier S, Kundrat S, Hasler CM. Effects of a functional foods nutrition education program with cardiac rehabilitation patients. J Cardiopulm Rehabil. 2003 Sep-Oct;23(5):334-40. doi: 10.1097/00008483-200309000-00002.
PubMed 14512777Pelletier S, Kundrat S, Hasler CM. Effects of an educational program on intent to consume functional foods. J Am Diet Assoc. 2002 Sep;102(9):1297-300. doi: 10.1016/s0002-8223(02)90286-5.
PubMed 12792631Hasler CM, Bloch AS, Thomson CA, Enrione E, Manning C. Position of the American Dietetic Association: Functional foods. J Am Diet Assoc. 2004 May;104(5):814-26. doi: 10.1016/j.jada.2004.03.015.
PubMed 15127071Van den Driessche M, Veereman-Wauters G. Functional foods in pediatrics. Acta Gastroenterol Belg. 2002 Jan-Mar;65(1):45-51.
PubMed 12014316Research MM. The Live Active Culture Yogurt Survey. Monroe Mendelsohn Research. Available at: http://www.dannon.com/dn/dnstore/cgi-bin/ProdDetEv_Cat_240861_SubCat_240857_NavRoot_200_NavID_241709_ProdID_289256.htm. Accessed May 24, 2005.
Tuohy KM, Rouzaud GC, Bruck WM, Gibson GR. Modulation of the human gut microflora towards improved health using prebiotics--assessment of efficacy. Curr Pharm Des. 2005;11(1):75-90. doi: 10.2174/1381612053382331.
PubMed 15638753Veilleux BG, Rowland I. Simulation of the rat intestinal ecosystem using a two-stage continuous culture system. J Gen Microbiol. 1981 Mar;123(1):103-15. doi: 10.1099/00221287-123-1-103.
PubMed 7033452Clausen MR, Bonnen H, Tvede M, Mortensen PB. Colonic fermentation to short-chain fatty acids is decreased in antibiotic-associated diarrhea. Gastroenterology. 1991 Dec;101(6):1497-504. doi: 10.1016/0016-5085(91)90384-w.
PubMed 1955116Engelbrektson AL, Korzenik JR, Sanders ME, Clement BG, Leyer G, Klaenhammer TR, Kitts CL. Analysis of treatment effects on the microbial ecology of the human intestine. FEMS Microbiol Ecol. 2006 Aug;57(2):239-50. doi: 10.1111/j.1574-6941.2006.00112.x.
PubMed 16867142
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics
- ClinicalTrials.gov ID
- NCT00848003
- Acronym / sponsor ID
- PHASE / R21AT003600-01A1
- Conditions
- Adults on Antibiotics
- Keywords
- Probiotics, BB-12, Yogurt, Antibiotics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Medstar Health Research Institute
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 20 Feb 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.
We 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 our drink and comply with the FDA's recommendations pertaining to an IND application, we will conduct a phase I safety study.
We hypothesize that BB-12 is safe in healthy adults ages 18 and over.
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 |
|---|---|---|
| 1. Active | Active comparator | Drug: Bifidobacterium animalis subsp. lactis strain BB-12Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) Probiotic, BB-12, supplemented yogurt, 4 ounces taken orally for 10 days |
| 2. Placebo | Placebo comparator | Drug: PlaceboStrawberry flavored yogurt |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Ability to speak and write English or Spanish
- Refrigerator for proper storage of drink
- Telephone access
- Enrollment must take place within 24 hours of starting antibiotics
- Treatment with a penicillin class antibiotic regimen for 10 days for an upper respiratory infection;
Key exclusion criteria (12 listed)
- Chronic conditions, such as diabetes or asthma, that require daily medication
- Allergy to strawberry
- Active diarrhea
- Allergy to penicillin class antibiotic
- Any other medicines used except prescribed antibiotic and anti-pyretic medicines
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 |
|---|---|---|
| Bifidobacterium animalis subsp. lactis strain BB-12Also: BB-12 probiotic supplemented yogurtBifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days | Drug | 1. Active |
| PlaceboAlso: Strawberry flavored yogurtStrawberry flavored yogurt | Drug | 2. Placebo |
Primary outcome
The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics.
Time frame: 1 year
1 secondary outcome
In addition to safety diary, participants will keep a daily diary to track number of bowel movements, if drink was consumed, if illness resulted in change in activity, over-the-counter medicines used and other illness symptoms.
Time frame: 1 year
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 20 May 2013.
- BackgroundHeath and Nutritional Properties of Probiotics in Food Including Powder Milk With Live Lactic Acid Bacteria: Food and Agriculture Organization of the United Nations and World Health Organization2005; 2001.
- Background: PubMed 11297958Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
- Background: PubMed 15629973Lin HC, Su BH, Chen AC, Lin TW, Tsai CH, Yeh TF, Oh W. Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants. Pediatrics. 2005 Jan;115(1):1-4. doi: 10.1542/peds.2004-1463.
- Background: PubMed 15180351Mastrandrea F, Coradduzza G, Serio G, Minardi A, Manelli M, Ardito S, Muratore L. Probiotics reduce the CD34+ hemopoietic precursor cell increased traffic in allergic subjects. Eur Ann Allergy Clin Immunol. 2004 Apr;36(4):118-22.
- Background: PubMed 12150178Rosenfeldt V, Michaelsen KF, Jakobsen M, Larsen CN, Moller PL, Pedersen P, Tvede M, Weyrehter H, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in young children hospitalized with acute diarrhea. Pediatr Infect Dis J. 2002 May;21(5):411-6. doi: 10.1097/00006454-200205000-00012.
- Background: PubMed 10547243Vanderhoof JA, Whitney DB, Antonson DL, Hanner TL, Lupo JV, Young RJ. Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children. J Pediatr. 1999 Nov;135(5):564-8. doi: 10.1016/s0022-3476(99)70053-3.
- Background: PubMed 14512777Pelletier S, Kundrat S, Hasler CM. Effects of a functional foods nutrition education program with cardiac rehabilitation patients. J Cardiopulm Rehabil. 2003 Sep-Oct;23(5):334-40. doi: 10.1097/00008483-200309000-00002.
- Background: PubMed 12792631Pelletier S, Kundrat S, Hasler CM. Effects of an educational program on intent to consume functional foods. J Am Diet Assoc. 2002 Sep;102(9):1297-300. doi: 10.1016/s0002-8223(02)90286-5.
- Background: PubMed 15127071Hasler CM, Bloch AS, Thomson CA, Enrione E, Manning C. Position of the American Dietetic Association: Functional foods. J Am Diet Assoc. 2004 May;104(5):814-26. doi: 10.1016/j.jada.2004.03.015.
- Background: PubMed 12014316Van den Driessche M, Veereman-Wauters G. Functional foods in pediatrics. Acta Gastroenterol Belg. 2002 Jan-Mar;65(1):45-51.
- BackgroundResearch MM. The Live Active Culture Yogurt Survey. Monroe Mendelsohn Research. Available at: http://www.dannon.com/dn/dnstore/cgi-bin/ProdDetEv_Cat_240861_SubCat_240857_NavRoot_200_NavID_241709_ProdID_289256.htm. Accessed May 24, 2005.
- Background: PubMed 15638753Tuohy KM, Rouzaud GC, Bruck WM, Gibson GR. Modulation of the human gut microflora towards improved health using prebiotics--assessment of efficacy. Curr Pharm Des. 2005;11(1):75-90. doi: 10.2174/1381612053382331.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bifidobacterium animalis subsp. lactis strain BB-12 in people with Adults on Antibiotics, run by Georgetown University at 1 site in United States.
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 30 inclusion and 12 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 20 May 2013. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848003, which also lists 102 linked publications.
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 20 May 2013.