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Pears + Sweet Potatoes for Infant Development (IMiND Trial)

N/A

Waitlist Available

Led By Jennifer Smilowitz, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Term infants born >37 weeks gestation

Be between 18 and 65 years old

Must not have

Family history of immunodeficiency syndrome(s)

Infants with any GI tract abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how a baby's eating habits and gut health affect their development.

Who is the study for?

This trial is for mother-infant pairs near UC Davis, California. Infants must be born full-term and exclusively breastfed for at least 5 months, ready to start solids between 4-7.5 months old without any GI abnormalities or recent antibiotic use. Mothers should be healthy, aged 21-45, non-smokers, and willing to avoid giving infants formula or supplements during the study.

What is being tested?

The study investigates how introducing solid foods like pears and sweet potatoes to exclusively breastfed infants affects their gut microbiome and development. It tracks changes in fecal microbiota as these new foods are introduced and relates them to developmental milestones.

What are the potential side effects?

Since this trial involves common food items (pears and sweet potatoes) given to infants starting on solids, there aren't typical side effects like with medications; however, potential reactions could include normal digestive adjustments or food sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby was born after 37 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My family has a history of immune system disorders.

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My infant has a gastrointestinal (GI) tract abnormality.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events and Treatments

Infant fecal microbial diversity

Infant fecal microbiota composition

Secondary study objectives

Dietary composition

Fecal metabolomics

Glycosidic linkages

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sweet PotatosExperimental Treatment1 Intervention

Infants will consume commercially available baby food sweet potato (SP) (Plum Organics, Just Sweet Potato) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of sweet potato to their infant at least three times per day for seven days in a row.

Group II: PearsExperimental Treatment1 Intervention

Infants will consume commercially available baby food pear (P) (Earth's Best, First Pears) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of pears to their infant at least three times per day for seven days in a row.

0 / 3Eligibility criteria met