Probiotic Supplementation for Infants of Diabetic Mothers

Overseen By Marie Hickey Swanson, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Probiotics

Disqualifiers: Alcohol, Tobacco, Type I Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a probiotic supplement can improve the gut health and brain development of babies born to mothers with gestational diabetes. The research focuses on how these supplements might affect the baby's memory and overall development. Participants in one group will take a daily probiotic capsule, while another group will not use any probiotics. This trial is ideal for pregnant individuals diagnosed with gestational diabetes who plan to exclusively breastfeed and are not already taking probiotics. As an unphased trial, participants can contribute to groundbreaking research that may enhance health outcomes for future generations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently taking an over-the-counter probiotic, you would not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that traditional probiotics like Lactobacillus rhamnosus GG are generally safe. These probiotics have proven effective in many situations. Studies indicate that probiotics, as live bacteria, can offer health benefits when taken in the right amounts. Although concerns about unwanted bacteria exist, such cases are rare.

Previous reports suggest that probiotics have a limited impact on gut bacteria balance, meaning they don't significantly alter gut bacteria in infants. Overall, probiotics are well-tolerated, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for infants of diabetic mothers, which typically focus on managing blood sugar levels and monitoring health after birth, the probiotic supplement being studied uses Lactobacillus rhamnosus GG to potentially support gut health from day one. Researchers are excited about this treatment because it introduces beneficial bacteria to the mother's system, which could positively affect the infant's microbiome development. This approach is different because it targets gut health proactively, offering a potentially natural and supplementary way to support infants' overall health right from birth.

What evidence suggests that probiotic supplementation might be an effective treatment for infants of diabetic mothers?

Research has shown that probiotics might benefit babies of mothers with diabetes by enhancing gut health and possibly brain development. In this trial, some participants will receive a probiotic supplement containing Lactobacillus rhamnosus GG. Studies have found that probiotics like Lactobacillus rhamnosus GG can improve the health of pregnant women with gestational diabetes, potentially offering immune benefits to their babies. Although the effect on gut bacteria might be small, probiotics are linked to other health benefits, such as strengthening the immune system. Overall, probiotics are considered safe and may support various health aspects during pregnancy and infancy. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals aged 21-45 with a BMI of 18.5-45 kg/m2, diagnosed with gestational diabetes, and planning to exclusively breastfeed for at least three months. It's not for those who smoke or drink alcohol during pregnancy/lactation, have type I Diabetes, other metabolic/endocrine diseases affecting infant feeding, or are already taking probiotics.

Inclusion Criteria

I am between 21 and 45 years old.

I am in my second or third trimester and have been diagnosed with gestational diabetes.

BMI 18.5-45 kg/m2 at first prenatal visit

Exclusion Criteria

History of type I Diabetes

Alcohol consumption >1 drink per week during pregnancy/lactation

Inability to speak/understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers take one Culturelle® Digestive Daily Probiotic Capsule per day from study enrollment through the first postpartum month

4 weeks

1 visit (in-person) at enrollment

Follow-up

Infant auditory and visual recognition ERP performance assessments at 1 and 6 months of age

6 months

2 visits (in-person) at 1 month and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Probiotic Supplement

Trial Overview The study is examining if taking probiotic supplements during pregnancy can influence the baby's gut bacteria and improve brain development outcomes in infants born to diabetic mothers.

How Is the Trial Designed?

Group I: Probiotic Supplement Experimental Treatment 1 Intervention

Participants (mothers) randomized to this arm will take one Culturelle® Digestive Daily Probiotic Capsule per day from study enrollment through the first postpartum month. Each capsule contains 10 billion CFU of Lactobacillus rhamnosus GG

Group II: No intervention Active Control 1 Intervention

Participants (mothers) randomized to this arm will agree to continue not taking any over the counter probiotic supplements from study enrollment through the first postpartum month.

Probiotic Supplement is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Probiotics for:

• Supportive therapy for gastrointestinal health
• Prevention of antibiotic-associated diarrhea

Approved in United States as Probiotics for:

• Dietary supplement for gut health
• Prevention of necrotizing enterocolitis in preterm infants

Approved in Canada as Probiotics for:

• Natural health product for digestive health
• Supportive therapy for irritable bowel syndrome

Approved in Japan as Probiotics for:

• Food for specified health uses (FOSHU) for gut health
• Prevention of allergic diseases

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

High-dose probiotic supplementation during late pregnancy and lactation significantly alters the cytokine profile in breast milk, enhancing levels of IL-6, IL-10, and TGF-β1, which may benefit infant immune development.

Newborns whose mothers received probiotics showed higher levels of secretory IgA (sIgA) in their stool, indicating improved immune transfer, and experienced fewer gastrointestinal issues like colic and regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial. Baldassarre, ME., Di Mauro, A., Mastromarino, P., et al.[2018]

A survey of 413 mothers in Alberta revealed that while 99.3% were aware of probiotics and 73.1% believed they were beneficial, only 50.8% had given probiotics to their infants, indicating a gap in usage despite awareness.

Many mothers expressed uncertainty about the safety of probiotics for infants, with 36.6% feeling uninformed, highlighting the need for more research and education to support informed decisions about probiotic use in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal perspectives on the use of probiotics in infants: a cross-sectional survey. Bridgman, SL., Azad, MB., Field, CJ., et al.[2021]

Probiotics are commonly used in pediatric care, but their effectiveness is not well-supported for many conditions, leading to concerns about their broad prescription without clear evidence.

While probiotics can be beneficial for certain specific disorders, they may also worsen clinical outcomes in some cases, highlighting the need for careful evaluation of their safety and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of probiotics: review of the evidence with focus on children. Michail, S., Sylvester, F., Fuchs, G., et al.[2007]

Probiotic supplementation during pregnancy and the neonatal period may help reduce adverse outcomes for both mothers and their babies, such as preterm delivery and perinatal infections.

The review discusses the potential benefits of probiotics in preventing gastrointestinal issues and atopic disorders in early life, highlighting their role in promoting overall health during critical developmental stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale of Probiotic Supplementation during Pregnancy and Neonatal Period. Baldassarre, ME., Palladino, V., Amoruso, A., et al.[2019]

Probiotic supplementation during pregnancy may help reduce the risk of complications such as preeclampsia, gestational diabetes, and vaginal infections, potentially benefiting both mothers and infants.

Current evidence suggests probiotics could also influence maternal and infant weight gain and reduce the risk of allergic diseases, but more large-scale, well-designed clinical trials are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics and pregnancy. Gomez Arango, LF., Barrett, HL., Callaway, LK., et al.[2018]

In a study involving 149 pregnant women with gestational diabetes, a daily probiotic intervention did not significantly improve fasting glucose levels or reduce the need for pharmacological therapy compared to a placebo.

However, the probiotic treatment did attenuate the normal increase in total and LDL cholesterol during late pregnancy, suggesting a potential benefit that warrants further investigation in this population at risk for metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of probiotics in women with gestational diabetes mellitus on metabolic health: a randomized controlled trial. Lindsay, KL., Brennan, L., Kennelly, MA., et al.[2022]

Probiotic supplements were found to significantly lower fasting plasma glucose (FPG) and improve insulin levels, insulin resistance, and insulin sensitivity in pregnant women, based on a systematic review of 20 randomized controlled trials involving 2972 participants.

The effects of probiotics were particularly pronounced in women with gestational diabetes mellitus (GDM) and healthy pregnant women, suggesting they may be a beneficial intervention for managing glucose metabolism during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic Supplements Improve Blood Glucose and Insulin Resistance/Sensitivity among Healthy and GDM Pregnant Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pan, YQ., Zheng, QX., Jiang, XM., et al.[2022]

Probiotics, which are beneficial bacteria and yeast found in fermented foods, are gaining attention for their potential to treat and prevent intestinal and other health disorders in infants and children.

This review highlights the need for further studies on the use of probiotics in neonatal enteric conditions to establish clear recommendations for their application in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of probiotics for neonatal enteric diseases. Shane, AL.[2008]

A feasibility study involving 50 obese pregnant women showed that daily probiotic supplementation did not significantly affect gestational weight gain, gestational diabetes mellitus, or infant birth weight, indicating no immediate clinical benefits in these areas.

However, the probiotic group exhibited a significant increase in gut microbiota diversity over time, suggesting that while the probiotics may not have improved pregnancy outcomes, they can positively influence gut health in obese pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multistrain Probiotic Increases the Gut Microbiota Diversity in Obese Pregnant Women: Results from a Randomized, Double-Blind Placebo-Controlled Study. Halkjær, SI., de Knegt, VE., Lo, B., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40507094/

The Effect of Probiotics on Health in Pregnancy and Infants This study assessed the effects of probiotic supplementation on infection frequency and immunity in pregnant women and infants, and on microbiome establishment

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05467150

Study Details | NCT05467150 | Maternal Probiotic ... The purpose of this study is to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved ...

3. withpower.com withpower.com/trial/phase-fetal-diseases-7-2022-aacd9

Probiotic Supplementation for Infants of Diabetic Mothers Research suggests that probiotics may help improve metabolic health in pregnant women with gestational diabetes and could offer immune benefits to infants when ...

4. nature.com nature.com/articles/s41598-018-26423-3

Probiotic supplementation and associated infant gut ... This retrospective clinical comparison suggests that probiotic exposure during infancy has limited effects on gut microbial composition yet is associated with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11018693/

Next-generation probiotics: the upcoming biotherapeutics Traditional probiotic microbes such as Bifidobacterium spp. and Lactobacillus spp. are generally recognized as safe and are effectively used in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10026873/

Emerging issues in probiotic safety: 2023 perspectives - PMC Of particular concern is the presence of unwanted live microbial contaminants. Since probiotics are designed to be administered as live microbes ...

7. nature.com nature.com/articles/s12276-020-0437-6

Live biotherapeutic products: the importance of a defined ... Probiotics have been defined as “Live microorganisms that when administered in adequate amounts confer a health benefit on the host”.