Effects of Fermented & Fiber-rich Foods on Maternal & Offspring Microbiome Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Difference in total number of species detected in stool as a measure of infant microbiota diversity.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •> 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.
排除标准
- •Pre-pregnancy BMI greater than 40
- •Blood pressure SBP: > 160 mmHg -OR- DBP: > 90 mmHg
- •Kidney disease
- •Liver disease
- •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
研究组 & 干预措施
Fiber
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.
干预措施: Fiber (Behavioral)
Fermented Foods
Participants will be asked to consume 6 servings of fermented foods per day.
干预措施: Fermented Foods (Behavioral)
Fiber + Fermented Foods
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day and to consume 6 servings of fermented foods per day.
干预措施: Fiber (Behavioral)
Fiber + Fermented Foods
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day and to consume 6 servings of fermented foods per day.
干预措施: Fermented Foods (Behavioral)
Comparator
Participants will receive usual care for pregnancy and postpartum.
结局指标
主要结局
Difference in total number of species detected in stool as a measure of infant microbiota diversity.
时间窗: 1 month postpartum
Difference in total number of species (ASVs - Amplicon Sequence Variants) detected in stool between the fiber, fermented, fiber + fermented and comparator arms at 1 month postpartum.
次要结局
- Characterize the infant allergy marker profile(6 months postpartum)
- Characterize the infant inflammatory marker profile(6 months postpartum)
- Change in the maternal inflammatory marker profile(Baseline and 36 weeks of pregnancy)
- Maternal Weight(36 weeks of pregnancy)
- Maternal glucose(Baseline and 36 weeks of pregnancy)
- Maternal fasting insulin(Baseline and 36 weeks of pregnancy)
- Change in the total number of species detected in stool as a measure of maternal microbiota diversity.(Baseline and 36 weeks of pregnancy)
- Infant Growth(18 months postpartum)
- Maternal triglycerides(Baseline and 36 weeks of pregnancy)
- Maternal LDL-cholesterol(Baseline and 36 weeks of pregnancy)
- Maternal HDL-cholesterol(Baseline and 36 weeks of pregnancy)
- Maternal systolic blood pressure(Baseline and 36 weeks of pregnancy)
- Maternal diastolic blood pressure(Baseline and 36 weeks of pregnancy)
研究者
Christopher Gardner
Rehnborg Farquhar Professor of Medicine
Stanford University