HealthyIMPRINTNCT02457338
Infant Microbiota and Probiotic Intake Study
A study testing Bifidobacterium in people with Healthy, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bifidobacterium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 7 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, non-smoking women and their infants
- Who are pregnant in their third trimester OR have delivered by C-section or vaginal birth within the past 7 days
- Patients who live within a 20-mile radius from University of California Davis Medical Center (UCDMC) or a 20-mile radius from UC Davis Campus in Davis, California.
- Plan to exclusively breastfeed their infants for at least 3 months
- Infants: 0-7 days old, delivered by C-section or vaginal delivery, born >37 weeks gestation, without medical complications that would preclude breastfeeding or alter gut microbiota
Who cannot join
- Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
- Infants who have taken antibiotics for more than 72 hours of life
- Infants who have consume formula feedings after day 7 of life
- Mothers and their infants who are not discharged from the hospital by day 4 of life due to complications
- Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants anytime throughout the study duration
- Women who have had any breast surgery or injury within the past 5 years that would reduce the chance of successful exclusive breastfeeding
- Mothers who have a chronic metabolic disease or obesity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study
The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.
Read the detailed description
The purpose of this clinical trial is to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis for the first 21 days of life in healthy term breastfed infants delivered via C-section or vaginal delivery on gut bacteria composition during, 1 week, and 1 month after supplementation compared with matched-control term infants receiving standard care. The investigators' specific aim is to compare the fecal microbiota (total B. infantis, total Bifidobacterium, total bacteria and composition of microbiota) between the supplement and control groups.
- Conditions
- Healthy
- Being tested
- Bifidobacterium
- Keywords
- C-section, Infants, Probiotic, B. infantis, Microbiota, Gut, Breast milk, Vaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BifidobacteriumDietary supplement
Also called B. infantis
| Study group | Role | What they receive |
|---|---|---|
| Supplement Group | Experimental | This group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation. Receives: Dietary Supplement: Bifidobacterium |
| Control Group | No intervention | This group will receive standard care plus lactation consultation only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant fecal B. infantis
Measure the change from baseline, during supplementation, and post supplementation
Measured: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal Bifidobacterium
Measure the change from baseline, during supplementation, and post supplementation
Measured: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal total bacteria
Measure the change from baseline, during supplementation, and post supplementation
Measured: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Infant fecal microbiota
Measure the change from baseline, during supplementation, and post supplementation
Measured: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Incidence of Adverse Events and Treatments
Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after B. infantis supplementation will be determined and reported daily by parental self-report questionnaire. General health status of the infant such as occurrence of any illness, health care visits for sickness, fever, antibiotic and medication use and parental assessments of infant's overall health.
Measured: Baseline-days 60
Incidence of Adverse Events and Treatments
Gastrointestinal symptoms and related symptoms (diarrhea, vomiting, constipation, colic, irritability) after B. infantis supplementation will be determined and reported parental self-report questionnaire. General health status of the infant such as occurrence of any illness, health care visits for sickness, fever, antibiotic and medication use and parental assessments of infant's overall health.
Measured: Months 4, 6, 8, 10, 12, 18 and 24
Secondary outcomes (11)
Infant fecal bacteria oligosaccharide consumption
Compare the oligosaccharides in human milk against the oligosaccharides in infant feces before, during, and after B. infantis supplementation by using liquid chromatography Chip-TOP mass spectrometry.
Measured: days 7, 14, 21, 32, 60
Infant fecal sialic acid concentrations
Measure the change in infant fecal sialic acid concentrations before, during, and after B. infantis supplementation in infant stool samples using enzymatic assay.
Measured: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Maternal fecal B. infantis, Bifidobacterium, total bacteria, and microbiota composition
Compare the maternal fecal B. infantis, bifidobacterium, total bacteria, and microbiota composition with changes in infant fecal microbiota
Measured: baseline, day 60
Infant weight
Determine the change in weight across the study duration using a digital infant scale and change in gut microbiota
Measured: birth, hospital discharge, days 15, 33, 61
Fecal inflammatory mediators
Compare GI function between infants in the B. infantis and control groups through the measurement of fecal inflammatory mediators.
Measured: Baseline-days 60
Fecal gut barrier function barrier markers
Compare GI function between infants in the B. infantis and control groups through the measurement of GI barrier function markers.
Measured: Baseline-days 60
Fecal lipopolysaccharide
Compare GI function between infants in the B. infantis and control groups through the measurement of fecal lipopolysaccharide binding.
Measured: Baseline-days 60
Fecal short-chain fatty acids
Determine the relationship between fecal microbiota composition and fecal short chain fatty acids
Measured: Baseline-days 60
Fecal microbiome-Follow-up
next generation sequencing
Measured: Months 4, 6, 8, 10, 12
Fecal B. infantis-Follow-up
Q Polymerase Chain Reaction (PCR)
Measured: Months 4, 6, 8, 10, 12
Fecal Bifidobacterium-Follow-up
Q PCR
Measured: Months 4, 6, 8, 10, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start1 Nov 2014
- Primary completion15 Jul 2016
- Study completion7 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Evolve BioSystems, Inc.
- Responsible party
- Sponsor
- Investigators
- Jennifer Smilowitz, PhD, Principal investigator, University of California, DavisMark Underwood, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457338
- Sponsor's protocol ID
- 631099
- Acronym
- IMPRINT
- Status last verified
- Dec 2025
- First submitted
- 27 May 2015
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Prior E, Santhakumaran S, Gale C, Philipps LH, Modi N, Hyde MJ. Breastfeeding after cesarean delivery: a systematic review and meta-analysis of world literature. Am J Clin Nutr. 2012 May;95(5):1113-35. doi: 10.3945/ajcn.111.030254. Epub 2012 Mar 28.
PubMed 22456657Bager P, Wohlfahrt J, Westergaard T. Caesarean delivery and risk of atopy and allergic disease: meta-analyses. Clin Exp Allergy. 2008 Apr;38(4):634-42. doi: 10.1111/j.1365-2222.2008.02939.x. Epub 2008 Feb 11.
PubMed 18266879Pei Z, Heinrich J, Fuertes E, Flexeder C, Hoffmann B, Lehmann I, Schaaf B, von Berg A, Koletzko S; Influences of Lifestyle-Related Factors on the Immune System and the Development of Allergies in Childhood plus Air Pollution and Genetics (LISAplus) Study Group. Cesarean delivery and risk of childhood obesity. J Pediatr. 2014 May;164(5):1068-1073.e2. doi: 10.1016/j.jpeds.2013.12.044. Epub 2014 Feb 5.
PubMed 24508442Bager P, Simonsen J, Nielsen NM, Frisch M. Cesarean section and offspring's risk of inflammatory bowel disease: a national cohort study. Inflamm Bowel Dis. 2012 May;18(5):857-62. doi: 10.1002/ibd.21805. Epub 2011 Jul 7.
PubMed 21739532Garrido D, Barile D, Mills DA. A molecular basis for bifidobacterial enrichment in the infant gastrointestinal tract. Adv Nutr. 2012 May 1;3(3):415S-21S. doi: 10.3945/an.111.001586.
PubMed 22585920Garrido D, Dallas DC, Mills DA. Consumption of human milk glycoconjugates by infant-associated bifidobacteria: mechanisms and implications. Microbiology (Reading). 2013 Apr;159(Pt 4):649-664. doi: 10.1099/mic.0.064113-0. Epub 2013 Mar 4.
PubMed 23460033Garrido D, Kim JH, German JB, Raybould HE, Mills DA. Oligosaccharide binding proteins from Bifidobacterium longum subsp. infantis reveal a preference for host glycans. PLoS One. 2011 Mar 15;6(3):e17315. doi: 10.1371/journal.pone.0017315.
PubMed 21423604Garrido D, Nwosu C, Ruiz-Moyano S, Aldredge D, German JB, Lebrilla CB, Mills DA. Endo-beta-N-acetylglucosaminidases from infant gut-associated bifidobacteria release complex N-glycans from human milk glycoproteins. Mol Cell Proteomics. 2012 Sep;11(9):775-85. doi: 10.1074/mcp.M112.018119. Epub 2012 Jun 27.
PubMed 22745059Garrido D, Ruiz-Moyano S, Jimenez-Espinoza R, Eom HJ, Block DE, Mills DA. Utilization of galactooligosaccharides by Bifidobacterium longum subsp. infantis isolates. Food Microbiol. 2013 Apr;33(2):262-70. doi: 10.1016/j.fm.2012.10.003. Epub 2012 Oct 22.
PubMed 23200660Ruiz-Moyano S, Totten SM, Garrido DA, Smilowitz JT, German JB, Lebrilla CB, Mills DA. Variation in consumption of human milk oligosaccharides by infant gut-associated strains of Bifidobacterium breve. Appl Environ Microbiol. 2013 Oct;79(19):6040-9. doi: 10.1128/AEM.01843-13. Epub 2013 Jul 26.
PubMed 23892749Underwood MA, Kalanetra KM, Bokulich NA, Lewis ZT, Mirmiran M, Tancredi DJ, Mills DA. A comparison of two probiotic strains of bifidobacteria in premature infants. J Pediatr. 2013 Dec;163(6):1585-1591.e9. doi: 10.1016/j.jpeds.2013.07.017. Epub 2013 Aug 29.
PubMed 23993139Underwood MA, Kalanetra KM, Bokulich NA, Mirmiran M, Barile D, Tancredi DJ, German JB, Lebrilla CB, Mills DA. Prebiotic oligosaccharides in premature infants. J Pediatr Gastroenterol Nutr. 2014 Mar;58(3):352-60. doi: 10.1097/MPG.0000000000000211.
PubMed 24135979Smilowitz JT, Lebrilla CB, Mills DA, German JB, Freeman SL. Breast milk oligosaccharides: structure-function relationships in the neonate. Annu Rev Nutr. 2014;34:143-69. doi: 10.1146/annurev-nutr-071813-105721. Epub 2014 May 15.
PubMed 24850388Sela DA. Bifidobacterial utilization of human milk oligosaccharides. Int J Food Microbiol. 2011 Sep 1;149(1):58-64. doi: 10.1016/j.ijfoodmicro.2011.01.025. Epub 2011 Jan 26.
PubMed 21342711Sela DA, Chapman J, Adeuya A, Kim JH, Chen F, Whitehead TR, Lapidus A, Rokhsar DS, Lebrilla CB, German JB, Price NP, Richardson PM, Mills DA. The genome sequence of Bifidobacterium longum subsp. infantis reveals adaptations for milk utilization within the infant microbiome. Proc Natl Acad Sci U S A. 2008 Dec 2;105(48):18964-9. doi: 10.1073/pnas.0809584105. Epub 2008 Nov 24.
PubMed 19033196
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study
- ClinicalTrials.gov ID
- NCT02457338
- Acronym / sponsor ID
- IMPRINT / 631099
- Conditions
- Healthy
- Keywords
- C-section, Infants, Probiotic, B. infantis, Microbiota, Gut, Breast milk, Vaginal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Evolve BioSystems, Inc.
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 7 Jun 2027 (estimated)
- First posted
- 29 May 2015 (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.
The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.
Detailed description
The purpose of this clinical trial is to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis for the first 21 days of life in healthy term breastfed infants delivered via C-section or vaginal delivery on gut bacteria composition during, 1 week, and 1 month after supplementation compared with matched-control term infants receiving standard care. The investigators' specific aim is to compare the fecal microbiota (total B. infantis, total Bifidobacterium, total bacteria and composition of microbiota) between the supplement and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Experimental | Dietary Supplement: BifidobacteriumThis group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation. |
| Control Group | No intervention | –This group will receive standard care plus lactation consultation only. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, non-smoking women and their infants
- Who are pregnant in their third trimester OR have delivered by C-section or vaginal birth within the past 7 days
- Patients who live within a 20-mile radius from University of California Davis Medical Center (UCDMC) or a 20-mile radius from UC Davis Campus in Davis, California.
- Plan to exclusively breastfeed their infants for at least 3 months
- Infants: 0-7 days old, delivered by C-section or vaginal delivery, born >37 weeks gestation, without medical complications that would preclude breastfeeding or alter gut microbiota
Key exclusion criteria (7 listed)
- Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
- Infants who have taken antibiotics for more than 72 hours of life
- Infants who have consume formula feedings after day 7 of life
- Mothers and their infants who are not discharged from the hospital by day 4 of life due to complications
- Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants anytime throughout the study duration
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 |
|---|---|---|
| BifidobacteriumAlso: B. infantis | Dietary supplement | Supplement Group |
Primary outcome
Infant fecal B. infantis
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Infant fecal Bifidobacterium
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Infant fecal total bacteria
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Infant fecal microbiota
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Measure the change from baseline, during supplementation, and post supplementation
Incidence of Adverse Events and Treatments
Time frame: Baseline-days 60
Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after B. infantis supplementation will be determined and reported daily by parental self-report questionnaire. General health status of the infant such as occurrence of any illness, health care visits for sickness, fever, antibiotic and medication use and parental assessments of infant's overall health.
Incidence of Adverse Events and Treatments
Time frame: Months 4, 6, 8, 10, 12, 18 and 24
Gastrointestinal symptoms and related symptoms (diarrhea, vomiting, constipation, colic, irritability) after B. infantis supplementation will be determined and reported parental self-report questionnaire. General health status of the infant such as occurrence of any illness, health care visits for sickness, fever, antibiotic and medication use and parental assessments of infant's overall health.
11 secondary outcomes
Infant fecal bacteria oligosaccharide consumption
Time frame: days 7, 14, 21, 32, 60
Infant fecal sialic acid concentrations
Time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
Maternal fecal B. infantis, Bifidobacterium, total bacteria, and microbiota composition
Time frame: baseline, day 60
Infant weight
Time frame: birth, hospital discharge, days 15, 33, 61
Fecal inflammatory mediators
Time frame: Baseline-days 60
Fecal gut barrier function barrier markers
Time frame: Baseline-days 60
Fecal lipopolysaccharide
Time frame: Baseline-days 60
Fecal short-chain fatty acids
Time frame: Baseline-days 60
Fecal microbiome-Follow-up
Time frame: Months 4, 6, 8, 10, 12
Fecal B. infantis-Follow-up
Time frame: Months 4, 6, 8, 10, 12
Fecal Bifidobacterium-Follow-up
Time frame: Months 4, 6, 8, 10, 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 22456657Prior E, Santhakumaran S, Gale C, Philipps LH, Modi N, Hyde MJ. Breastfeeding after cesarean delivery: a systematic review and meta-analysis of world literature. Am J Clin Nutr. 2012 May;95(5):1113-35. doi: 10.3945/ajcn.111.030254. Epub 2012 Mar 28.
- Background: PubMed 18266879Bager P, Wohlfahrt J, Westergaard T. Caesarean delivery and risk of atopy and allergic disease: meta-analyses. Clin Exp Allergy. 2008 Apr;38(4):634-42. doi: 10.1111/j.1365-2222.2008.02939.x. Epub 2008 Feb 11.
- Background: PubMed 24508442Pei Z, Heinrich J, Fuertes E, Flexeder C, Hoffmann B, Lehmann I, Schaaf B, von Berg A, Koletzko S; Influences of Lifestyle-Related Factors on the Immune System and the Development of Allergies in Childhood plus Air Pollution and Genetics (LISAplus) Study Group. Cesarean delivery and risk of childhood obesity. J Pediatr. 2014 May;164(5):1068-1073.e2. doi: 10.1016/j.jpeds.2013.12.044. Epub 2014 Feb 5.
- Background: PubMed 21739532Bager P, Simonsen J, Nielsen NM, Frisch M. Cesarean section and offspring's risk of inflammatory bowel disease: a national cohort study. Inflamm Bowel Dis. 2012 May;18(5):857-62. doi: 10.1002/ibd.21805. Epub 2011 Jul 7.
- Background: PubMed 22585920Garrido D, Barile D, Mills DA. A molecular basis for bifidobacterial enrichment in the infant gastrointestinal tract. Adv Nutr. 2012 May 1;3(3):415S-21S. doi: 10.3945/an.111.001586.
- Background: PubMed 23460033Garrido D, Dallas DC, Mills DA. Consumption of human milk glycoconjugates by infant-associated bifidobacteria: mechanisms and implications. Microbiology (Reading). 2013 Apr;159(Pt 4):649-664. doi: 10.1099/mic.0.064113-0. Epub 2013 Mar 4.
- Background: PubMed 21423604Garrido D, Kim JH, German JB, Raybould HE, Mills DA. Oligosaccharide binding proteins from Bifidobacterium longum subsp. infantis reveal a preference for host glycans. PLoS One. 2011 Mar 15;6(3):e17315. doi: 10.1371/journal.pone.0017315.
- Background: PubMed 22745059Garrido D, Nwosu C, Ruiz-Moyano S, Aldredge D, German JB, Lebrilla CB, Mills DA. Endo-beta-N-acetylglucosaminidases from infant gut-associated bifidobacteria release complex N-glycans from human milk glycoproteins. Mol Cell Proteomics. 2012 Sep;11(9):775-85. doi: 10.1074/mcp.M112.018119. Epub 2012 Jun 27.
- Background: PubMed 23200660Garrido D, Ruiz-Moyano S, Jimenez-Espinoza R, Eom HJ, Block DE, Mills DA. Utilization of galactooligosaccharides by Bifidobacterium longum subsp. infantis isolates. Food Microbiol. 2013 Apr;33(2):262-70. doi: 10.1016/j.fm.2012.10.003. Epub 2012 Oct 22.
- Background: PubMed 23892749Ruiz-Moyano S, Totten SM, Garrido DA, Smilowitz JT, German JB, Lebrilla CB, Mills DA. Variation in consumption of human milk oligosaccharides by infant gut-associated strains of Bifidobacterium breve. Appl Environ Microbiol. 2013 Oct;79(19):6040-9. doi: 10.1128/AEM.01843-13. Epub 2013 Jul 26.
- Background: PubMed 23993139Underwood MA, Kalanetra KM, Bokulich NA, Lewis ZT, Mirmiran M, Tancredi DJ, Mills DA. A comparison of two probiotic strains of bifidobacteria in premature infants. J Pediatr. 2013 Dec;163(6):1585-1591.e9. doi: 10.1016/j.jpeds.2013.07.017. Epub 2013 Aug 29.
- Background: PubMed 24135979Underwood MA, Kalanetra KM, Bokulich NA, Mirmiran M, Barile D, Tancredi DJ, German JB, Lebrilla CB, Mills DA. Prebiotic oligosaccharides in premature infants. J Pediatr Gastroenterol Nutr. 2014 Mar;58(3):352-60. doi: 10.1097/MPG.0000000000000211.
- University of California, Davis Foods for Health InstituteLink provided by the sponsor.
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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.
Jennifer Smilowitz, PhD principal investigator
University of California, Davis
Mark Underwood, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium in people with Healthy, run by University of California, Davis 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Infant fecal B. infantis (time frame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60). The study lists 6 primary outcomes in all. 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 NCT02457338, which also lists 30 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 5 Dec 2025.