Can your diet shape your Baby's gut bugs?
NCT ID NCT05123612
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how eating fermented and fiber-rich foods during pregnancy changes the gut bacteria of mothers and their babies. Researchers will track 135 pregnant women and their infants to see if diet affects the types of bacteria passed from mom to baby. The goal is to learn more about how early-life gut health develops.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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135 people
The number who actually took part.
- Started
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Jan 2022
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * \> 18 years of age * Singleton pregnancies * Recruit during the first trimester and up to 22 weeks of pregnancy. * Healthy subjects willing and able to provide blood, stool, vaginal swab, and breast milk samples. * Must be able to provide signed and dated informed consent. Exclusion Criteria: * Pre-pregnancy BMI greater than 40 * Blood pressure SBP: \> 160 mmHg -OR- DBP: \> 90 mmHg * Kidney disease * Liver disease * Anemia * Symptomatic gallstones * History of bariatric surgery * Acute disease at time of enrollment (i.e. flu or gastroenteritis). May delay sampling until subject recovers. * Chronic, clinically significant, unstable (unresolved, requiring on-going changes to medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history * History of active uncontrolled gastrointestinal disorders or diseases including: * Inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; * Irritable bowel syndrome (IBS) (moderate-severe); * Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated) * Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection. * Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time. * Confirmed or suspected autoimmune disease Medications: * Weight loss medications * Regular high dose aspirin * Regular use of prescription opiate pain medication If taken in the past 2 months: * Systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular or oral) * Corticosteroids (intravenous, intramuscular, oral, nasal or inhaled) * Cytokines * Methotrexate or immunosuppressive cytotoxic agents Diet \& Lifestyle: * Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or \> 14 drinks/week. * Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products Maternal chronic medical conditions: * Pre-gestational diabetes (T1 or T2) * History of gestational diabetes * On medication that is an immune modulators or chronic steroid use * Hyperemesis gravidarum Pregnancy history: * Preterm birth * Recurrent pregnancy loss
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stanford University
Stanford, California, 94305, United States
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Other studies related to the condition(s) this trial covers.
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