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Maternal & Offspring Microbiome Study (MOMS)

Primary Purpose

Pregnancy Related, Microbiome, Immune Function

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fiber
Fermented Foods
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Related focused on measuring Pregnancy, Microbiome, Immune function, Inflammation

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Fiber

Fermented Foods

Fiber + Fermented Foods

Comparator

Arm Description

Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.

Participants will be asked to consume 6 servings of fermented foods per day.

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.

Participants will receive usual care for pregnancy and postpartum.

Outcomes

Primary Outcome Measures

Difference in total number of species detected in stool as a measure of infant microbiota diversity.
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.

Secondary Outcome Measures

Change in the total number of species detected in stool as a measure of maternal microbiota diversity.
Change in differences in total number of species (ASVs- Amplicon Sequence Variants) detected in stool from baseline to 36 weeks of pregnancy between fiber, fermented, fiber + fermented, and comparator arms.
Change in the maternal inflammatory marker profile
Change in the differences in inflammatory markers (β-NGF, LIF-R, IL-12B, IL10, CASP-8, LAP TGF-β-1, CD6, CD5, MCP-2, IL6, CCL20, IL18, VEGFA, MMP-10, MCP-4, CCL4, CXCL10, CCL19, FGF-21) detected in blood samples from baseline to 36 weeks of pregnancy between fiber, fermented, fiber + fermented, and comparator arms.
Characterize the infant inflammatory marker profile
Difference in amount of inflammatory markers (β-NGF, LIF-R, IL-12B, IL10, CASP-8, LAP TGF-β-1, CD6, CD5, MCP-2, IL6, CCL20, IL18, VEGFA, MMP-10, MCP-4, CCL4, CXCL10, CCL19, FGF-21) detected in heel stick blood between fiber, fermented, fiber + fermented, and comparator arms at 6 months postpartum.
Characterize the infant allergy marker profile
Difference in amount of allergy markers (skin prick testing) detected in heel stick blood between fiber, fermented, fiber + fermented, and comparator arms at 6 months postpartum.
Infant Growth
Difference in weight-for-length growth chart percentiles between fiber, fermented, fiber + fermented, and comparator arms at 18 months postpartum.
Maternal Weight
Differences in the number of participants who gained weight within the pregnancy weight gain recommendations between fiber, fermented, fiber + fermented, and comparator arms measured at 36 weeks.
Maternal systolic blood pressure
Change from baseline in systolic blood pressure at 36 weeks of pregnancy.
Maternal diastolic blood pressure
Change from baseline in diastolic blood pressure at 36 weeks of pregnancy.
Maternal LDL-cholesterol
Change from baseline in LDL cholesterol at 36 weeks of pregnancy.
Maternal HDL-cholesterol
Change from baseline in HDL cholesterol at 36 weeks of pregnancy.
Maternal triglycerides
Change from baseline in triglycerides at 36 weeks of pregnancy.
Maternal glucose
Change from baseline in glucose at 36 weeks of pregnancy.
Maternal fasting insulin
Change from baseline in fasting insulin at 36 weeks of pregnancy.

Full Information

First Posted
October 27, 2021
Last Updated
September 27, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05123612
Brief Title
Maternal & Offspring Microbiome Study
Acronym
MOMS
Official Title
Effects of Fermented & Fiber-rich Foods on Maternal & Offspring Microbiome Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. We know that the composition of the microbiome can have an important effect on our 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Microbiome, Immune Function, Inflammation
Keywords
Pregnancy, Microbiome, Immune function, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fiber
Arm Type
Experimental
Arm Description
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.
Arm Title
Fermented Foods
Arm Type
Experimental
Arm Description
Participants will be asked to consume 6 servings of fermented foods per day.
Arm Title
Fiber + Fermented Foods
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
Participants will receive usual care for pregnancy and postpartum.
Intervention Type
Behavioral
Intervention Name(s)
Fiber
Intervention Description
Additional 20 grams of fiber/day.
Intervention Type
Behavioral
Intervention Name(s)
Fermented Foods
Intervention Description
6 servings of fermented foods/day
Primary Outcome Measure Information:
Title
Difference in total number of species detected in stool as a measure of infant microbiota diversity.
Description
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.
Time Frame
1 month postpartum
Secondary Outcome Measure Information:
Title
Change in the total number of species detected in stool as a measure of maternal microbiota diversity.
Description
Change in differences in total number of species (ASVs- Amplicon Sequence Variants) detected in stool from baseline to 36 weeks of pregnancy between fiber, fermented, fiber + fermented, and comparator arms.
Time Frame
Baseline and 36 weeks of pregnancy
Title
Change in the maternal inflammatory marker profile
Description
Change in the differences in inflammatory markers (β-NGF, LIF-R, IL-12B, IL10, CASP-8, LAP TGF-β-1, CD6, CD5, MCP-2, IL6, CCL20, IL18, VEGFA, MMP-10, MCP-4, CCL4, CXCL10, CCL19, FGF-21) detected in blood samples from baseline to 36 weeks of pregnancy between fiber, fermented, fiber + fermented, and comparator arms.
Time Frame
Baseline and 36 weeks of pregnancy
Title
Characterize the infant inflammatory marker profile
Description
Difference in amount of inflammatory markers (β-NGF, LIF-R, IL-12B, IL10, CASP-8, LAP TGF-β-1, CD6, CD5, MCP-2, IL6, CCL20, IL18, VEGFA, MMP-10, MCP-4, CCL4, CXCL10, CCL19, FGF-21) detected in heel stick blood between fiber, fermented, fiber + fermented, and comparator arms at 6 months postpartum.
Time Frame
6 months postpartum
Title
Characterize the infant allergy marker profile
Description
Difference in amount of allergy markers (skin prick testing) detected in heel stick blood between fiber, fermented, fiber + fermented, and comparator arms at 6 months postpartum.
Time Frame
6 months postpartum
Title
Infant Growth
Description
Difference in weight-for-length growth chart percentiles between fiber, fermented, fiber + fermented, and comparator arms at 18 months postpartum.
Time Frame
18 months postpartum
Title
Maternal Weight
Description
Differences in the number of participants who gained weight within the pregnancy weight gain recommendations between fiber, fermented, fiber + fermented, and comparator arms measured at 36 weeks.
Time Frame
36 weeks of pregnancy
Title
Maternal systolic blood pressure
Description
Change from baseline in systolic blood pressure at 36 weeks of pregnancy.
Time Frame
Baseline and 36 weeks of pregnancy
Title
Maternal diastolic blood pressure
Description
Change from baseline in diastolic blood pressure at 36 weeks of pregnancy.
Time Frame
Baseline and 36 weeks of pregnancy
Title
Maternal LDL-cholesterol
Description
Change from baseline in LDL cholesterol at 36 weeks of pregnancy.
Time Frame
Baseline and 36 weeks of pregnancy
Title
Maternal HDL-cholesterol
Description
Change from baseline in HDL cholesterol at 36 weeks of pregnancy.
Time Frame
Baseline and 36 weeks of pregnancy
Title
Maternal triglycerides
Description
Change from baseline in triglycerides at 36 weeks of pregnancy.
Time Frame
Baseline and 36 weeks of pregnancy
Title
Maternal glucose
Description
Change from baseline in glucose at 36 weeks of pregnancy.
Time Frame
Baseline and 36 weeks of pregnancy
Title
Maternal fasting insulin
Description
Change from baseline in fasting insulin at 36 weeks of pregnancy.
Time Frame
Baseline and 36 weeks of pregnancy

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Garnder, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://med.stanford.edu/nutrition/research/current-studies/fefifo-moms.html
Description
Study description

Learn more about this trial

Maternal & Offspring Microbiome Study

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