Whole Food, Plant Based, Tube Fed, Microbiome Pediatric Study

I am so excited to write about this amazing research that is going on RIGHT HERE in PITTSBURGH, PA!

Last year, I had the distinct honor to meet a local pediatric surgeon who is doing some thought-provoking and fascinating MICROBIOME research at Children’s Hospital of Pittsburgh. If you have read my blog in the past you know that I am fascinated with the connection of the microbiome to other conditions such as Autism. And you also know from this blog the I have experienced first hand the amazing impact FOOD can have on HEALTH, specifically my own daughter’s improved health. I look forward to following this study and wait in anticipation of the (positive) results!

This study is currently recruiting subjects (Children ages 2-17) who are tube fed (G tube and any enterally fed child is eligible including children with GJ’s.) If your child falls into this category, I highly encourage you to read further. If not, please consider passing this along to someone whom you know whose child may benefit. (if you are interested, please leave a comment below, message us on our Facebook page,  or use the Contact Us form with your contact info and we will connect you with the lead researcher for this study).

Here is the “Cliff Notes” version of the study details:

Children 2-17 years are eligible in this study if they are predominantly fed via feeding tube and if they have not yet tried a blenderized or whole foods formula.  Participants receive 2 months supply of Nourish®, and all that we need from the children are fecal samples collected before and after initiation of the Nourish diet.

 

Here is more “science” for all of you parents and professionals (like me!) who want the nitty-gritty details along with the annotated bibliography!

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

Objective: What is the overall purpose of this research study?  Determine the effect of the first commercially available whole foods pediatric feeding tube formula (named Nourish) on the gut microbiota.

Specific Aims: List the goals of the proposed study :

Aim 1: We will test the hypothesis that a 2 month conversion of tube-fed children to Nourish from standard pediatric tube feedings will increase the abundance of anaerobic protective species of bacteria within fecal samples.

Aim 2: We will test the hypothesis that a 2 month conversion of tube-fed children to Nourish from standard pediatric tube feedings will increase the concentration of fecal short chain fatty acids.

Aim 3: We will obtain exploratory pilot data about the tolerability of the Nourish diet relative to patient formula regimens prior to study initiation.

Background: Briefly describe previous findings or observations that provide the background leading to this proposal.

The human gut contains 10^14 to 10^15 bacterial organisms, which is 10-100 times the number of cells in the human body (Foster et al., 2013). A healthy microbiota has a balance in variety, distribution, species composition, and metabolic byproducts (Flint et al., 2012). Influences on the microbiome include malnutrition, obesity, illnesses (such as chronic intestinal disorders), and the use of antibiotics (Ottman et al., 2012). In addition, diet has a substantive impact on the composition of the gut microbiota, and changes after dietary interventions take place within days and reverse just as quickly (Flint et al., 2012). Some examples of diet’s influence include breast-fed babies having a more homogeneous and stable microbiota with an abundance of Bifidobacterium spp. vs. formula-fed babies. An adult diet high in protein or fat produces a microbiota that consists of more Bacteroides species while a high plant fiber diet produces a microbiota with more Prevotella (Flint et al.,2012).

The microbiota plays a role in human development and function of metabolism, barrier, and stress (Foster et al., 2013). Within a child’s gut microbiota, the first colonizers are facultative anaerobes. Then, the gut is colonized with obligate anaerobes, like Faecalibacterium spp., Lachnospiraceae, and Bifidobacterium spp., the later of which is considered to be an organism essential for a healthy gut (Flint et al., 2012). The introduction of solid food after 1-3 years affects the microbiota by increasing in Bacteroides, which are linked to inflammation, obesity, and risk of adiposity (Hollister et al., 2015). The microbiome is thought to play an important role in brain development and behavior in children and can be linked to anxiety and depression (Hollister et al., 2015). The main source of short chain fatty acids (SCFA) in the human gut is the microbiota in the colon growing under anaerobic conditions. This is where soluble undigested carbohydrates ferment into substances like butyrate and acetate. SCFA play several functions, which include being a main anion of the colon and energy source for epithelial cells, controlling the appetite through the Free FA Receptor 2/3 (FFAR2 and FFAR3), having anticancer (butyrate) and anti-inflammatory effects, and changing gut motility (Flint et al., 2012). The integrity of the blood brain barrier (BBB) is influenced by SCFAs, due to their role in increasing the expression of claudin-5 and occludin of the tight junction, without which serum metabolites can cross and influence neurological systems (Braniste et al., 2014). Children are fed through a tube connected to their stomach, otherwise known as a G-tube, for various reasons, including chronically for conditions like cerebral palsy, degenerative diseases, and spinal cord injuries or temporarily for failure-to-thrive or oral aversions. Children with G-tubes are traditionally fed a formula diet and can experience constipation, diarrhea, lack of attention, discomfort and failure-to-thrive. Currently available ubiquitous pediatric tube feeding formulas include Pediasure, Nutramigen, and Boost Kid Essentials.

Some of the problems with a formula G-tube diet include a lack of soluble fiber and intolerance of bolus feedings, thus necessitating continuous drip feedings throughout the day. Several studies of chronically ill children fed through G-tubes have reported diarrhea and constipation (Guimber et al., 2010). When these subjects were given fiber supplementation, the children experienced decreased stool pH and increased Bifidobacteria abundance, which led to the diet being well tolerated (Guimber et al., 2010). Liquid Hope ® produced by Functional Formularies ® is a nutritional product that is made of blenderized whole foods and is hypoallergenic. It has is the world’s first commercially available SHELF STABLE whole foods feeding formula. It is widely acknowledged to meet the definition of “medical foods” and therefore is not subject to any regulatory requirements that specifically apply to drugs. Nevertheless, Functional Formularies has undergone two thorough FDA reviews and Liquid Hope has been used for several years with no known safety problems.

A new pediatric product similar to Liquid Hope ®, Nourish ®, is expected to be commercially available in February 2016. This product is nearly identical to Liquid Hope but has been reformulated to more specifically meet the nutritional needs of children. The soluble fiber and natural sugars contained in this nutritional product may have benefits over standard formula used in chronically tube-fed pediatric patients.

In this study, we propose to start pediatric patients on the nutritional product Nourish ® over the course of 2 months and observe changes in the microbiota and abundance of SCFAs.

1. Braniste, V., Al-Asmakh, M., Kowal, C., Anuar, F., Abbaspour, A., Toth, M., Korecka, A., Bakocevic, N., Guan, N.L., Kundu, P., et al. (2014). The gut microbiota influences bloodbrain barrier permeability in mice. Sci. Transl. Med. 6,263ra158.

2. Flint HJ, Scott KP, Louis P, Duncan SH. 2012. The role of the gut microbiota in nutrition and health. Nat. Rev. Gastroenterology. Hepatol. 9:577–89

3. Foster JA, McVey Neufeld K-A. Gut–brain axis: how the microbiome influences anxiety and depression. Trends Neurosci. 2013;36(5):305–12. doi: 10.1016/j.tins.2013.01.005.

4. Guimber D, Bourgois B, Beghin L, et al. Effect of multifibre mixture with prebiotic components on bifidobacteria and stool pH in tube-fed children. Br J Nutr 2010 Nov;104(10):1514-22. PMID: 20687970. X-3, X-4, X-5

5. Hollister, E. B., Riehle, K., Luna, R. A., Weidler, E. M., Rubio-Gonzales, M., Mistretta, T.-A., … Versalovic, J. (2015). Structure and function of the healthy pre-adolescent pediatric gut microbiome. Microbiome, 3, 36. http://doi.org.pitt.idm.oclc.org/10.1186/s40168-015-0101-x

6. Ottman N, Smidt H, de Vos WM and Belzer C (2012) The function of our microbiota: who is out there and what do they do? Front. Cell. Inf. Microbio. 2:104. doi: 10.3389/fcimb.2012.00104

Existing information or knowledge is this research intended to fill?

Currently available tube feeding formulas leave much to be desired but have not been closely studied because there has been a complete absence of alternatives to traditional formula. We believe that the use of whole foods based formulas can revolutionize the approach to nutrition in tube-fed individuals. A major interest in our group involves the connection between diet and the gut microbiota. Here we will test the hypothesis that conversion to Nourish results in rapid transition to a healthier gut microbiome. Although we are not primarily investigating clinical variables in this study, we speculate that future studies may demonstrate that beneficial changes in the microbiota can lead to improved clinical outcomes.

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

For more details or to be considered for enrollment, please contact us.

**At the moment this study is recruiting LOCAL participants due to no funding for any travel expenses. However, if you are a family who is not local to the Pittsburgh, PA area but are interested in this trial, please still reach out and we will try to help connect you with someone locally or pass your name on to the researcher should another trial follow this one that will have the funds to reach a wider audience, in the future.