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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

IMiND Trial 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.Check my eligibility

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.See study design

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.

IMiND Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My baby was born after 37 weeks of pregnancy.

IMiND Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events and Treatments

Infant fecal microbial diversity

Infant fecal microbiota composition

Secondary outcome measures

Dietary composition

Fecal metabolomics

Glycosidic linkages

+9 more

IMiND 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

UC Davis Foods for Health InstituteUNKNOWN

Mengniu DairyUNKNOWN

University of California, DavisLead Sponsor

910 Previous Clinical Trials

4,706,889 Total Patients Enrolled

1 Trials studying Infant Development

8 Patients Enrolled for Infant Development

Media Library

Pears (NA) Clinical Trial Eligibility Overview. Trial Name: NCT03229863 — N/A

Infant Development Research Study Groups: Sweet Potatos, Pears

Infant Development Clinical Trial 2023: Pears Highlights & Side Effects. Trial Name: NCT03229863 — N/A

Pears (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03229863 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial involve persons of thirty years or greater in age?

"This clinical trial only considers individuals aged 21 to 45. However, there are additional studies available for participants younger or older than this required range; 225 trials geared towards those under 18 and 616 aimed at those over 65 years of age."

Answered by AI

Is it feasible to register at present for this clinical research?

"As per the information on clinicaltrials.gov, this investigation is not presently seeking participants. It was initially listed on April 18th 2017 and has recently been updated on January 26th 2022. Although it isn't searching for patients at present, there are 804 other trials currently recruiting individuals."

Answered by AI

Who is the ideal candidate for participation in this trial?

"To qualify for this medical research, participants must be affected by the targeted infection and between 21-45 years old. This investigation is aiming to enrol a total of 102 patients."

Answered by AI

What objectives is this medical experiment aiming to accomplish?

"The prime purpose of this clinical trial, which will be tracked over 14, 19, 25, 29, 60 90 120 150 and 180 days respectively is to determine the incidence of adverse events and treatments. Secondary aims involve exploring infant secretor status - looking at oligosaccharides present in saliva- as well as fecal microbiota composition; measuring changes in gastrointestinal function for tolerability assessment before and after introduction of complementary foods with markers such as inflammatory mediators; finally gauging the correlation between microbiome abundance/functionality and food glycan composition."

Answered by AI

Recent research and studies

NatureJournal

Enterotypes of the Human Gut Microbiome

Arumugam, Manimozhiyan, MetaHIT Consortium (additional members), Jeroen Raes, Eric Pelletier, Denis Le Paslier, Takuji Yamada, Daniel R. Mende, et al.. 2011. “Enterotypes of the Human Gut Microbiome”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature09944.

Applied and Environmental MicrobiologyJournal

Low Relative Abundances of the Mucolytic Bacterium Akkermansia Muciniphila and Bifidobacterium Spp. In Feces of Children with Autism

Wang, Lv, Claus T. Christophersen, Michael J. Sorich, Jacobus P. Gerber, Manya T. Angley, and Michael A. Conlon. 2011. “Low Relative Abundances of the Mucolytic Bacterium Akkermansia Muciniphila and Bifidobacterium Spp. In Feces of Children with Autism”. Applied and Environmental Microbiology. American Society for Microbiology. doi:10.1128/aem.05212-11.

PediatricsJournal

Factors Influencing the Composition of the Intestinal Microbiota in Early Infancy

Penders, John, Carel Thijs, Cornelis Vink, Foekje F. Stelma, Bianca Snijders, Ischa Kummeling, Piet A. van den Brandt, and Ellen E. Stobberingh. 2006. “Factors Influencing the Composition of the Intestinal Microbiota in Early Infancy”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2005-2824.

AnaerobeJournal