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Probiotic

Probiotic Transmission Between Infants

N/A
Recruiting
Led By Diana Taft, BA, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Maternal vaccination against COVID19 (2 doses Pfizer or Moderna and within 6 months of second dose or 2 doses Pfizer or Moderna and booster.) COVID vaccination is required for maternal participation as this is a study meant to enable transmission of beneficial bacteria species between infants, and infants are too young to be vaccinated.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will test if probiotics consumed by the baby can be shared with other babies in a weekly support group. Results will show if probiotics can be shared between infants.

Who is the study for?
This trial is for mothers intending to exclusively breastfeed for six months, with healthy single babies born at term (>=36 weeks), and who are vaccinated against COVID-19. Infants older than one month, those given non-study probiotics, with congenital abnormalities or immunocompromised status cannot participate.Check my eligibility
What is being tested?
The study tests if beneficial bacteria like B. longum subsp. infantis and L. reuteri can be transmitted between infants during lactation support groups by comparing HMO-consuming and non-HMO consuming probiotics through stool samples before and after attendance.See study design
What are the potential side effects?
While specific side effects are not listed, typical reactions to probiotics in infants may include mild digestive changes such as gas or bloating; however, these products generally have a good safety profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a mother vaccinated against COVID19 with the required doses and timeline.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Transmission of probiotics to non-supplemented infants

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-HMO consuming bacteriaExperimental Treatment1 Intervention
Infants will be given a daily non-HMO consuming probiotic (L. reuteri) for four weeks
Group II: HMO consuming bacteriaExperimental Treatment1 Intervention
Infants will given a daily HMO consuming probiotic (B. infantis) for four weeks

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,256 Total Patients Enrolled
Diana Taft, BA, PhDPrincipal InvestigatorUniversity of Florida

Media Library

B. longum subsp. infantis (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05703659 — N/A
Transmission Research Study Groups: HMO consuming bacteria, Non-HMO consuming bacteria
Transmission Clinical Trial 2023: B. longum subsp. infantis Highlights & Side Effects. Trial Name: NCT05703659 — N/A
B. longum subsp. infantis (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05703659 — N/A

Frequently Asked Questions

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

Does the current research encompass individuals above a certain age group?

"The age requirements for enrollment in this trial stipulate that participants must be above 18 years old and below 62."

Answered by AI

Do I meet the prerequisites to participate in this medical experiment?

"To meet the eligibility criteria for this medical study, candidates must have contracted a transmissible illness and be aged between 18 and 62. The research team is currently recruiting 60 patients."

Answered by AI

Are there current opportunities to participant in this trial?

"According to the details listed on clinicaltrials.gov, this particular medical study is currently not accepting participants. The trial was first launched on February 1st 2023 and last updated a few weeks ago; however, there are two other trials that are presently recruiting patients for their studies."

Answered by AI
~18 spots leftby Aug 2024