Microbial ColonizationMOMNCT03222804
Milk Oriented Microbiota
A study testing Bifidobacterium in people with Microbial Colonization, 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 vaginally who consume breast milk, formula, or both 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
- Microbial Colonization
- What is being tested?
- Bifidobacterium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 16 May 2017
- Phase
- Interventional
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with infants age 8 to 12 weeks
- Term infants born >37 weeks gestation
- Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA or within a 20-mile UCDMC
- Women and infants who live in one location
- Infants born vaginally
- Infants who are either exclusively formula-fed, exclusively breastfed or mixed-fed
- Women who are mixed and formula feeding their infants who are willing to switch infant formulas and use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) throughout the first two months of the study
- Women who are breastfeeding but introduce infant formula to their infants during the first two months of the study who are willing to use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) for the first two months of the study
Who cannot join
- Women who have lived in the United States or other developed nation for less than 10 consecutive years
- Multiple infants born to one mother
- Plan to feed infants solid foods before infants turn 5 months of age
- Family history of cow milk or soy allergy and/or infants allergic to cow milk protein or soy
- Infants born by C-section
- Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
Show all 12Show fewer
- Infants who have taken antibiotics 4 weeks before enrollment and more than one course of antibiotics since birth
- Infants who have taken probiotics since birth
- Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants for the first two months of the study
- Mothers who have a chronic metabolic disease or obesity
- Mothers who currently smoke or plan to resume smoking during the study period
- Infants who consume solid foods or other liquids other than breastmilk, infant formula or water
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: Establishing a Milk Oriented Microbiota in Healthy Term Infants
The purpose of this study is to determine if supplementing healthy term infants delivered vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.
Read the detailed description
The purpose of phase 1 of this two phase clinical trial is to determine: 1) the effect of decreasing levels of human milk oligosaccharides on fecal B.infantis during and after 21 days of supplementation with Evolve activated B.infantis using exclusively breastfed, mixed-fed and exclusively formula-fed infants; 2) determine the effect of Evolve activated B.infantis on fecal B.infantis levels in exclusively breastfed infants compared to pre-supplementation levels.
- Conditions
- Microbial Colonization
- Being tested
- Bifidobacterium
- Keywords
- Infants, Probiotic, B. Infantis
- Medical subject headings
- Communicable Diseases
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
Each B. infantis (strain: BIEVC001) dose will be provided in one 625 mg sachet delivering 156 mg of live bacteria at a dose of 9x10^9 CFU plus 469 mg of pharmaceutical-grade lactose as the excipient and dispensed to participants by the study personnel.
| Study group | Role | What they receive |
|---|---|---|
| Exclusively breastfed | Active comparator | Exclusive breastfeeding will be defined at screening as infants who have not consumed any infant formula after 7 days postnatal and have been exclusively breastfed without formula between day 7 of life through the end on the Lead-in period. ). Infants will consume B. infantis for twenty-one consecutive days. Receives: Dietary Supplement: Bifidobacterium |
| Exclusively formula fed | Active comparator | Exclusive formula feeding is defined at screening as infants who consume only infant formula between day 7 of life through the end on the Lead-in period. Infants will consume B. infantis for twenty-one consecutive days. Receives: Dietary Supplement: Bifidobacterium |
| Mixed fed | Active comparator | Mixed feeding is defined at screening as infants who consume a combination of infant formula and breast milk between day 7 of life through the end on the Lead-in period. Infants will consume B. infantis for twenty-one consecutive days. Receives: Dietary Supplement: Bifidobacterium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant fecal B. infantis
The change in infant fecal B. infantis before, during and after supplementation.
Measured: Change from baseline to day 280
Infant fecal Bifidobacterium
The change in infant fecal Bifidobacterium before, during, and after supplementation.
Measured: Change from baseline to day 280
Infant fecal total bacteria
The change in infant fecal total bacteria before, during and after supplementation.
Measured: Change from baseline to day 280
Infant fecal microbiome
The change in infant fecal microbiome before, during and after supplementation.
Measured: Change from baseline to day 280
Infant gastrointestinal symptoms
Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after supplementation will be determined and reported daily by parental self-report questionnaire.
Measured: Change from baseline to day 50
Infant health status
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: Change from baseline to day 280
Secondary outcomes (6)
Maternal secretor status
Determine the relationship between human milk oligosaccharides in breast milk and infant fecal microbiome.
Measured: Change from baseline to day 280
Infant fecal sialic acid concentrations
The change in infant fecal sialic acid and fucose concentrations before, during and after supplementation in infant stool samples.
Measured: Change from baseline to day 280
Infant fecal microbiome and lifestyle
Determine the relationship between the following factors determined by self-report questionnaires: parity, maternal and infant antibiotic intake and maternal use of antimicrobials, infant intake of formula; and the change infant fecal microbiome.
Measured: Change from baseline to day 280
Infant weight
Determine the relationship between infant weight and change in fecal microbiome.
Measured: Change from baseline to day 280
Infant fecal short chain fatty acids
Determine the relationship between fecal short chain fatty acids and fecal microbiome.
Measured: Change from baseline to day 280
Infant gastrointestinal function
Determine the relationship between GI function (fecal inflammatory, GI barrier mediators, LPS) and fecal microbiome.
Measured: Change from baseline to day 280
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start15 May 2017
- Primary completion16 May 2017
- Study completion16 May 2017
Why it stopped: Did not receive funding to start the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The feeding patterns of eighty eligible infants (8 to 12 weeks in age) will be characterized based on a 7-day diet record that will be filled out by their mothers during the 7-day lead-in period starting with Day -7 and ending with Day -1. Of the eighty infants, twenty will be exclusive breast feeders (BF), twenty will be exclusive formula feeders (FF) and forty will be mixed-feeders (MF). Infants in all three feeding groups will consume B. infantis for twenty-one consecutive days. Participants will then enter the observational phase until their infant turns 1 year old.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT03222804
- Sponsor's protocol ID
- 738191
- Acronym
- MOM
- Status last verified
- Dec 2024
- First submitted
- 7 Jul 2017
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bager 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 18266879Thavagnanam S, Fleming J, Bromley A, Shields MD, Cardwell CR. A meta-analysis of the association between Caesarean section and childhood asthma. Clin Exp Allergy. 2008 Apr;38(4):629-33. doi: 10.1111/j.1365-2222.2007.02780.x.
PubMed 18352976Negele K, Heinrich J, Borte M, von Berg A, Schaaf B, Lehmann I, Wichmann HE, Bolte G; LISA Study Group. Mode of delivery and development of atopic disease during the first 2 years of life. Pediatr Allergy Immunol. 2004 Feb;15(1):48-54. doi: 10.1046/j.0905-6157.2003.00101.x.
PubMed 14998382Renz-Polster H, David MR, Buist AS, Vollmer WM, O'Connor EA, Frazier EA, Wall MA. Caesarean section delivery and the risk of allergic disorders in childhood. Clin Exp Allergy. 2005 Nov;35(11):1466-72. doi: 10.1111/j.1365-2222.2005.02356.x.
PubMed 16297144Eggesbo M, Botten G, Stigum H, Nafstad P, Magnus P. Is delivery by cesarean section a risk factor for food allergy? J Allergy Clin Immunol. 2003 Aug;112(2):420-6. doi: 10.1067/mai.2003.1610.
PubMed 12897751Lewis ZT, Totten SM, Smilowitz JT, Popovic M, Parker E, Lemay DG, Van Tassell ML, Miller MJ, Jin YS, German JB, Lebrilla CB, Mills DA. Maternal fucosyltransferase 2 status affects the gut bifidobacterial communities of breastfed infants. Microbiome. 2015 Apr 10;3:13. doi: 10.1186/s40168-015-0071-z. eCollection 2015.
PubMed 25922665Ninonuevo MR, Park Y, Yin H, Zhang J, Ward RE, Clowers BH, German JB, Freeman SL, Killeen K, Grimm R, Lebrilla CB. A strategy for annotating the human milk glycome. J Agric Food Chem. 2006 Oct 4;54(20):7471-80. doi: 10.1021/jf0615810.
PubMed 17002410Ninonuevo MR, Perkins PD, Francis J, Lamotte LM, LoCascio RG, Freeman SL, Mills DA, German JB, Grimm R, Lebrilla CB. Daily variations in oligosaccharides of human milk determined by microfluidic chips and mass spectrometry. J Agric Food Chem. 2008 Jan 23;56(2):618-26. doi: 10.1021/jf071972u. Epub 2007 Dec 19.
PubMed 18088092Ninonuevo MR, Ward RE, LoCascio RG, German JB, Freeman SL, Barboza M, Mills DA, Lebrilla CB. Methods for the quantitation of human milk oligosaccharides in bacterial fermentation by mass spectrometry. Anal Biochem. 2007 Feb 1;361(1):15-23. doi: 10.1016/j.ab.2006.11.010. Epub 2006 Nov 27.
PubMed 17181994Sela 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 19033196Sela 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, Garrido D, Lerno L, Wu S, Tan K, Eom HJ, Joachimiak A, Lebrilla CB, Mills DA. Bifidobacterium longum subsp. infantis ATCC 15697 alpha-fucosidases are active on fucosylated human milk oligosaccharides. Appl Environ Microbiol. 2012 Feb;78(3):795-803. doi: 10.1128/AEM.06762-11. Epub 2011 Dec 2.
PubMed 22138995Sela DA, Li Y, Lerno L, Wu S, Marcobal AM, German JB, Chen X, Lebrilla CB, Mills DA. An infant-associated bacterial commensal utilizes breast milk sialyloligosaccharides. J Biol Chem. 2011 Apr 8;286(14):11909-18. doi: 10.1074/jbc.M110.193359. Epub 2011 Feb 2.
PubMed 21288901Garrido 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, 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 21423604
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Milk Oriented Microbiota in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT03222804
- Acronym / sponsor ID
- MOM / 738191
- Conditions
- Microbial Colonization
- Keywords
- Infants, Probiotic, B. Infantis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive funding to start the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Evolve BioSystems, Inc.
- Study start
- 15 May 2017 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 19 Jul 2017 (actual)
- 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 vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.
Detailed description
The purpose of phase 1 of this two phase clinical trial is to determine: 1) the effect of decreasing levels of human milk oligosaccharides on fecal B.infantis during and after 21 days of supplementation with Evolve activated B.infantis using exclusively breastfed, mixed-fed and exclusively formula-fed infants; 2) determine the effect of Evolve activated B.infantis on fecal B.infantis levels in exclusively breastfed infants compared to pre-supplementation levels.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The feeding patterns of eighty eligible infants (8 to 12 weeks in age) will be characterized based on a 7-day diet record that will be filled out by their mothers during the 7-day lead-in period starting with Day -7 and ending with Day -1. Of the eighty infants, twenty will be exclusive breast feeders (BF), twenty will be exclusive formula feeders (FF) and forty will be mixed-feeders (MF). Infants in all three feeding groups will consume B. infantis for twenty-one consecutive days. Participants will then enter the observational phase until their infant turns 1 year old.
| Arm | Type | Receives |
|---|---|---|
| Exclusively breastfed | Active comparator | Dietary Supplement: BifidobacteriumExclusive breastfeeding will be defined at screening as infants who have not consumed any infant formula after 7 days postnatal and have been exclusively breastfed without formula between day 7 of life through the end on the Lead-in period. ). Infants will consume B. infantis for twenty-one consecutive days. |
| Exclusively formula fed | Active comparator | Dietary Supplement: BifidobacteriumExclusive formula feeding is defined at screening as infants who consume only infant formula between day 7 of life through the end on the Lead-in period. Infants will consume B. infantis for twenty-one consecutive days. |
| Mixed fed | Active comparator | Dietary Supplement: BifidobacteriumMixed feeding is defined at screening as infants who consume a combination of infant formula and breast milk between day 7 of life through the end on the Lead-in period. Infants will consume B. infantis for twenty-one consecutive days. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women with infants age 8 to 12 weeks
- Term infants born >37 weeks gestation
- Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA or within a 20-mile UCDMC
- Women and infants who live in one location
- Infants born vaginally
Key exclusion criteria (12 listed)
- Women who have lived in the United States or other developed nation for less than 10 consecutive years
- Multiple infants born to one mother
- Plan to feed infants solid foods before infants turn 5 months of age
- Family history of cow milk or soy allergy and/or infants allergic to cow milk protein or soy
- Infants born by C-section
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. infantisEach B. infantis (strain: BIEVC001) dose will be provided in one 625 mg sachet delivering 156 mg of live bacteria at a dose of 9x10^9 CFU plus 469 mg of pharmaceutical-grade lactose as the excipient and dispensed to participants by the study personnel. | Dietary supplement | Exclusively breastfed, Exclusively formula fed, Mixed fed |
Primary outcome
Infant fecal B. infantis
Time frame: Change from baseline to day 280
The change in infant fecal B. infantis before, during and after supplementation.
Infant fecal Bifidobacterium
Time frame: Change from baseline to day 280
The change in infant fecal Bifidobacterium before, during, and after supplementation.
Infant fecal total bacteria
Time frame: Change from baseline to day 280
The change in infant fecal total bacteria before, during and after supplementation.
Infant fecal microbiome
Time frame: Change from baseline to day 280
The change in infant fecal microbiome before, during and after supplementation.
Infant gastrointestinal symptoms
Time frame: Change from baseline to day 50
Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after supplementation will be determined and reported daily by parental self-report questionnaire.
Infant health status
Time frame: Change from baseline to day 280
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.
6 secondary outcomes
Maternal secretor status
Time frame: Change from baseline to day 280
Infant fecal sialic acid concentrations
Time frame: Change from baseline to day 280
Infant fecal microbiome and lifestyle
Time frame: Change from baseline to day 280
Infant weight
Time frame: Change from baseline to day 280
Infant fecal short chain fatty acids
Time frame: Change from baseline to day 280
Infant gastrointestinal function
Time frame: Change from baseline to day 280
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- 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 18352976Thavagnanam S, Fleming J, Bromley A, Shields MD, Cardwell CR. A meta-analysis of the association between Caesarean section and childhood asthma. Clin Exp Allergy. 2008 Apr;38(4):629-33. doi: 10.1111/j.1365-2222.2007.02780.x.
- Background: PubMed 14998382Negele K, Heinrich J, Borte M, von Berg A, Schaaf B, Lehmann I, Wichmann HE, Bolte G; LISA Study Group. Mode of delivery and development of atopic disease during the first 2 years of life. Pediatr Allergy Immunol. 2004 Feb;15(1):48-54. doi: 10.1046/j.0905-6157.2003.00101.x.
- Background: PubMed 16297144Renz-Polster H, David MR, Buist AS, Vollmer WM, O'Connor EA, Frazier EA, Wall MA. Caesarean section delivery and the risk of allergic disorders in childhood. Clin Exp Allergy. 2005 Nov;35(11):1466-72. doi: 10.1111/j.1365-2222.2005.02356.x.
- Background: PubMed 12897751Eggesbo M, Botten G, Stigum H, Nafstad P, Magnus P. Is delivery by cesarean section a risk factor for food allergy? J Allergy Clin Immunol. 2003 Aug;112(2):420-6. doi: 10.1067/mai.2003.1610.
- Background: PubMed 25922665Lewis ZT, Totten SM, Smilowitz JT, Popovic M, Parker E, Lemay DG, Van Tassell ML, Miller MJ, Jin YS, German JB, Lebrilla CB, Mills DA. Maternal fucosyltransferase 2 status affects the gut bifidobacterial communities of breastfed infants. Microbiome. 2015 Apr 10;3:13. doi: 10.1186/s40168-015-0071-z. eCollection 2015.
- Background: PubMed 17002410Ninonuevo MR, Park Y, Yin H, Zhang J, Ward RE, Clowers BH, German JB, Freeman SL, Killeen K, Grimm R, Lebrilla CB. A strategy for annotating the human milk glycome. J Agric Food Chem. 2006 Oct 4;54(20):7471-80. doi: 10.1021/jf0615810.
- Background: PubMed 18088092Ninonuevo MR, Perkins PD, Francis J, Lamotte LM, LoCascio RG, Freeman SL, Mills DA, German JB, Grimm R, Lebrilla CB. Daily variations in oligosaccharides of human milk determined by microfluidic chips and mass spectrometry. J Agric Food Chem. 2008 Jan 23;56(2):618-26. doi: 10.1021/jf071972u. Epub 2007 Dec 19.
- Background: PubMed 17181994Ninonuevo MR, Ward RE, LoCascio RG, German JB, Freeman SL, Barboza M, Mills DA, Lebrilla CB. Methods for the quantitation of human milk oligosaccharides in bacterial fermentation by mass spectrometry. Anal Biochem. 2007 Feb 1;361(1):15-23. doi: 10.1016/j.ab.2006.11.010. Epub 2006 Nov 27.
- Background: PubMed 19033196Sela 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.
- Background: PubMed 21342711Sela 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.
- Background: PubMed 22138995Sela DA, Garrido D, Lerno L, Wu S, Tan K, Eom HJ, Joachimiak A, Lebrilla CB, Mills DA. Bifidobacterium longum subsp. infantis ATCC 15697 alpha-fucosidases are active on fucosylated human milk oligosaccharides. Appl Environ Microbiol. 2012 Feb;78(3):795-803. doi: 10.1128/AEM.06762-11. Epub 2011 Dec 2.
Related trials for Microbial Colonization
RecruitingPhase 1
Restoration of the Gut Microbiome After Cesarean Section
Microbial Colonization
Recruiting
The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation
Bacterial Vaginosis, Microbial Colonization
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
RecruitingObservational study
Understanding the Burn Wound Microbiome: Comparing Traditional Wound Cultures to Next Generation Sequencing Technology
Microbial Colonization, Burns
Recruiting
Microbial Evaluation of MK1 and Clip Attachments in Implant Overdentures
Evaluation of Microbial Colonization Around Implants and Overdenture Surfaces Using MK1 and Clip Attachments
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 Microbial Colonization, 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 8 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: withdrawn, as of the sponsor's last update on 11 Dec 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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: Change from baseline to day 280). 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 NCT03222804, which also lists 56 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 11 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.