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Probiotic

Probiotics for Healthy Infants (IMPRINT Trial)

N/A

Waitlist Available

Led By Mark Underwood, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 4, 6, 8, 10, 12, 18 and 24

Awards & highlights

IMPRINT Trial Summary

This trial is testing whether giving a probiotic supplement to infants will help increase the level of good bacteria in their stool.

Who is the study for?

This trial is for healthy, non-smoking women in their third trimester or who have recently given birth and plan to exclusively breastfeed for at least 3 months. Their infants must be 0-7 days old, delivered full-term without complications that affect breastfeeding or gut bacteria. Participants must live within a 20-mile radius of UC Davis locations.Check my eligibility

What is being tested?

The study tests if giving Bifidobacterium probiotics to healthy newborns (delivered via C-section or vaginal birth) increases beneficial bacteria in their stool over a period of 21 days.See study design

What are the potential side effects?

While the study involves administering probiotics which are generally considered safe, potential side effects could include mild digestive upset such as gas or bloating.

IMPRINT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 4, 6, 8, 10, 12, 18 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 4, 6, 8, 10, 12, 18 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 4, 6, 8, 10, 12, 18 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events and Treatments

Infant fecal B. infantis

Infant fecal Bifidobacterium

+2 more

Secondary outcome measures

Fecal B. infantis-Follow-up

Fecal Bifidobacterium-Follow-up

Fecal gut barrier function barrier markers

+8 more

IMPRINT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Supplement GroupExperimental Treatment1 Intervention

This group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation.

Group II: Control GroupActive Control1 Intervention

This group will receive standard care plus lactation consultation only.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bifidobacterium

2006

N/A

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Evolve BioSystems, Inc.Industry Sponsor

7 Previous Clinical Trials

585 Total Patients Enrolled

University of California, DavisLead Sponsor

910 Previous Clinical Trials

4,706,871 Total Patients Enrolled

Mark Underwood, MDPrincipal InvestigatorUniversity of California, Davis

3 Previous Clinical Trials

359 Total Patients Enrolled

Media Library

Bifidobacterium (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02457338 — N/A

Healthy Subjects Research Study Groups: Control Group, Supplement Group

Healthy Subjects Clinical Trial 2023: Bifidobacterium Highlights & Side Effects. Trial Name: NCT02457338 — N/A

Bifidobacterium (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02457338 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria to be eligible for this medical research?

"This medical study seeks 120 applicants aged 21 to 45 years old with a healthy background. To qualify, candidates must fit the criteria that includes pregnant women in their third trimester or those who have birthed within 7 days via C-section or naturally; non-smokers and infants under one week of age delivered by either method at 37 weeks gestation without any complications affecting breastfeeding or gut microbiota from areas 20 miles surrounding UCDMC and UC Davis Campus."

Answered by AI

Does the protocol for this clinical trial include individuals of advanced age?

"The research team is currently recruiting individuals between 21 and 45 years of age to participate in this trial."

Answered by AI

What objectives are researchers hoping to achieve through this investigation?

"The goals of this trial, which will be evaluated at baseline and on days 10, 14, 17, 21, 25, 29. 32 40 50 and 60 are to assess the presence of Bifidobacterium in infant feces as well as other relevant secondary outcomes such as oligosaccharide consumption via liquid chromatography Chip-TOP mass spectrometry; sialic acid concentrations through enzymatic assay; and GI barrier function markers."

Answered by AI

Are there still openings available for those interested in taking part in this experiment?

"The clinicaltrials.gov website confirms that this trial is no longer recruiting patients, as the last edit to its page was on September 28th 2022. Although participation in this particular study has closed, 839 other trials are currently advertised and looking for volunteers."

Answered by AI

Recent research and studies

Clinical & Experimental AllergyJournal

Caesarean Delivery and Risk of Atopy and Allergic Disesase: Meta-analyses

Bager, P., J. Wohlfahrt, and T. Westergaard. 2008. “Caesarean Delivery and Risk of Atopy and Allergic Disesase: Meta-analyses”. Clinical & Experimental Allergy. Wiley. doi:10.1111/j.1365-2222.2008.02939.x.

Molecular & Cellular ProteomicsJournal

Endo-β-n-acetylglucosaminidases from Infant Gut-associated Bifidobacteria Release Complex N-glycans from Human Milk Glycoproteins

Garrido, Daniel, Charles Nwosu, Santiago Ruiz-Moyano, Danielle Aldredge, J. Bruce German, Carlito B. Lebrilla, and David A. Mills. 2012. “Endo-β-n-acetylglucosaminidases from Infant Gut-associated Bifidobacteria Release Complex N-glycans from Human Milk Glycoproteins”. Molecular & Cellular Proteomics. Elsevier BV. doi:10.1074/mcp.m112.018119.

bifidobacteriumJournal

Elevated Fecal Ph Indicates a Profound Change in the Breastfed Infant Gut Microbiome Due to Reduction of <i>bifidobacterium</i> over the Past Century

Henrick, Bethany M., Andra A. Hutton, Michelle C. Palumbo, Giorgio Casaburi, Ryan D. Mitchell, Mark A. Underwood, Jennifer T. Smilowitz, and Steven A. Frese. 2018. “Elevated Fecal Ph Indicates a Profound Change in the Breastfed Infant Gut Microbiome Due to Reduction of bifidobacterium over the Past Century”. Edited by Julia Oh. Msphere. American Society for Microbiology. doi:10.1128/msphere.00041-18.

The American Journal of Clinical NutritionJournal