Clinical trial NCT05123612: Maternal & Offspring Microbiome Study
Official title: Effects of Fermented & Fiber-rich Foods on Maternal & Offspring Microbiome Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Microbiome
Immune Function
Inflammation
Keywords: Pregnancy
Microbiome
Immune function
Inflammation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to learn how different dietary interventions affect microbiota diversity in pregnant women and the transmission of microbiota to their infants during pregnancy, birth, and postpartum.

Detailed description: This research study aims to understand the relationship of dietary fiber, fermented foods, and the microbiome, specifically during pregnancy and postpartum. The investigators know that the composition of the microbiome can have an important effect on overall health, and a greater variety will confer more health benefits. Research suggests that maternal microbiota play an important role in the development of their offspring's microbiota during pregnancy, childbirth, and breastfeeding. The purpose of this study is to assess how diet impacts maternal microbiome during pregnancy and their infant's microbiome up to about two years postpartum.

Potential pregnant participants will be recruited during their first trimester up to 22 weeks. After completion of the baseline visit and sample collection, they will be randomized to start a diet high in fiber, high in fermented foods, high in both fiber and fermented foods, or a usual care group. Participants will be asked to provide blood, stool, vaginal swab, and breast milk samples periodically throughout the study. Cord blood will be collected after childbirth, and infant blood from a heel stick will be collected twice. They will also be asked to fill out online questionnaires and perform dietary recalls with study diet assessors.

After completing the study, participants will be invited to continue to participate in an extension of the study for approximately three and a half additional years. The purpose of this extension is to continue to assess how diet impacts the mother's microbiome postpartum and the child's microbiome up to about 5 years of age.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in total number of species detected in stool as a measure of infant microbiota diversity.
timeFrame: 1 month postpartum
Secondary outcomes:
measure: Change in the total number of species detected in stool as a measure of maternal microbiota diversity.
timeFrame: Baseline and 36 weeks of pregnancy
measure: Change in the maternal inflammatory marker profile
timeFrame: Baseline and 36 weeks of pregnancy
measure: Characterize the infant inflammatory marker profile
timeFrame: 6 months postpartum
measure: Characterize the infant allergy marker profile
timeFrame: 6 months postpartum
measure: Infant Growth
timeFrame: 18 months postpartum
measure: Maternal Weight
timeFrame: 36 weeks of pregnancy
measure: Maternal systolic blood pressure
timeFrame: Baseline and 36 weeks of pregnancy
measure: Maternal diastolic blood pressure
timeFrame: Baseline and 36 weeks of pregnancy
measure: Maternal LDL-cholesterol
timeFrame: Baseline and 36 weeks of pregnancy
measure: Maternal HDL-cholesterol
timeFrame: Baseline and 36 weeks of pregnancy
measure: Maternal triglycerides
timeFrame: Baseline and 36 weeks of pregnancy
measure: Maternal glucose
timeFrame: Baseline and 36 weeks of pregnancy
measure: Maternal fasting insulin
timeFrame: Baseline and 36 weeks of pregnancy
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Christopher D Garnder, PhD
role: PRINCIPAL_INVESTIGATOR
References: