Baby Foods - Plant for Gut Microbiomes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Colorado Anschutz Medical Campus, Aurora, CO
Gut Microbiomes+1 More
Baby Foods - Plant - Other
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether different foods during the time of early complementary feeding affects growth and the development of bacteria living inside your baby's gut.

See full description

Eligible Conditions

  • Gut Microbiomes
  • Linear Growth

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Baby Foods - Plant will improve 5 primary outcomes and 9 secondary outcomes in patients with Gut Microbiomes. Measurement will happen over the course of Over 6 months.

Over 6 months
Body composition
Dietary intake
Gut Microbiome
Head Circumference
Length
Plasma alpha 1-acid glycoprotein (AGP)
Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)
Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)
Serum c-reactive protein (CRP-hs)
Total calories in breast milk
Total carbohydrates in breast milk
Total fat in breast milk
Total protein in breast milk
Weight

Trial Safety

Trial Design

4 Treatment Groups

Study Provided Diet - Meat
1 of 4
Study Provided Diet - Plant
1 of 4
Study Provided Diet - Dairy
1 of 4
Traditional Diet
1 of 4
Experimental Treatment
Non-Treatment Group

This trial requires 300 total participants across 4 different treatment groups

This trial involves 4 different treatments. Baby Foods - Plant is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Study Provided Diet - Meat
Other
A group of complementary foods provided to participants by researchers.
Study Provided Diet - Plant
Other
A group of complementary foods provided to participants by researchers.
Study Provided Diet - Dairy
Other
A group of complementary foods provided to participants by researchers.
Traditional Diet
Other
No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly over 6 months for reporting.

Closest Location

University of Colorado Anschutz Medical Campus - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Full term;
Generally healthy without conditions that would affect protein metabolism or growth
No previous complementary food exposure
Vaginal delivery
No prior exposure of antibiotics during delivery or after birth
Able to consume study foods
Single birth.

Patient Q&A Section

Can gut microbiomes be cured?

"The gut microbiome is highly plastic. Despite the presence of efficient treatments, the dynamics of most gut microbial species are difficult to modulate. This may be one factor limiting treatment outcomes." - Anonymous Online Contributor

Unverified Answer

What causes gut microbiomes?

"The gut microbiome is the first cellular interface between the host and the external environment and it can have an enormous impact on host fitness. To better understand and treat disease, we need a clearer understanding of what impacts the microbiome and when, how, and why it does so. This is especially important when considering the role of the gut microbiome in human health, disease and drug response." - Anonymous Online Contributor

Unverified Answer

What are common treatments for gut microbiomes?

"The treatment of gut microbiomes differs across different diseases and locations of the gut. Clinician-oriented treatments and drugs that target specific bacterial or bacterial-host-target interactions may help to improve human health." - Anonymous Online Contributor

Unverified Answer

How many people get gut microbiomes a year in the United States?

"The proportion of individuals in the United States getting gut microbiomes is likely much higher than what we found in Germany, where we studied 10,000 samples. There is a high percentage of individuals with normal-appearing small and large intestine microbiome profiles, and these profiles could not be separated by socioeconomic status or geographic location. The low proportion of individuals with known risk factors for gut microbiome disorders (diabetes, obesity) suggests that these risk factors are not the main drivers of the normal-appearing profiles." - Anonymous Online Contributor

Unverified Answer

What is gut microbiomes?

"The composition of the gut microbiome can be changed by lifestyle, drugs (e.g. antibiotics), and diseases (e.g. diabetes). A better understanding of these interactions could lead to improvements in treatment of diseases, such as obesity and diabetes." - Anonymous Online Contributor

Unverified Answer

What are the signs of gut microbiomes?

"Findings from a recent study suggests that a combination of diet and the microbiomes influence each other. Furthermore, this study is the first of its kind to demonstrate that the microbiome and diet influence the immune system." - Anonymous Online Contributor

Unverified Answer

What is the latest research for gut microbiomes?

"Gut microbiota-based therapy may help modulate the imbalance of gut microbiota and regulate immune function. The development of strategies to activate, reestablish, and modify bacterial communities may provide a new avenue for manipulation of inflammatory diseases." - Anonymous Online Contributor

Unverified Answer

How does baby foods - plant work?

"The infant diet has a profound impact on gut microbiota, and these changes are likely to have a profound impact on later immune competence. In a recent study, findings suggest that it may be possible to modulate early infant colonisation by nutrition to create an appropriate adult microbiota, thereby lowering the risk of a number of complex human diseases." - Anonymous Online Contributor

Unverified Answer

Does gut microbiomes run in families?

"Differences in gut microbiomes between monozygotic and dizygotic twins were minimal, suggesting that most of the variation in bacterial composition is genetically determined rather than environmental. No specific bacterial genera appeared more common in monozygotic twins (of either sex), suggesting that genetic factors influence the gut microbiome as well as environmental factors. Future studies are needed to address the role of gut microbiota in the physiology and pathology of inflammatory bowel disease." - Anonymous Online Contributor

Unverified Answer

Does baby foods - plant improve quality of life for those with gut microbiomes?

"The GF baby group had more favourable GI and mood outcomes than the BF baby group and those without GFs, over a four-month period. GFs may beneficially support a baby and its microbiome." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of baby foods - plant?

"We observed that about half of the plant related products marketed to babies have reported adverse reactions, mainly dermatitis. We also observed the presence of species of gut microbiota in both nonfood related samples and some food related samples. Future work will investigate the link between gut flora and gut related GI reactions to baby foods in a prospective cohort study." - Anonymous Online Contributor

Unverified Answer

How serious can gut microbiomes be?

"The majority of human-associated microbial species can be readily found in a healthy gut microbiome; however, most can not be reliably isolated, detected and characterized by culture methods. For species that are clinically relevant, we need new reliable and sensitive techniques for their reliable detection." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
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