Fiber Food Introduction for Short Bowel Syndrome

(GREENBEANS Trial)

Enrolling by invitation at 1 trial location

Overseen By Wenjing Zong, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Intestinal diseases, Ileostomy, Jejunostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether people with and without short bowel syndrome (SBS) can tolerate green bean puree. SBS is a condition where the body struggles to absorb nutrients due to insufficient bowel length. Participants will gradually add green bean puree to their enteral formulas over three weeks to observe its effects on digestion, weight, and gut health. The study seeks individuals with a history of SBS, as documented in medical records, or those without intestinal issues who consume little to no fiber. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on gut health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable antibiotic regimen starting from 2 weeks before the study and throughout the study period.

What prior data suggests that green bean puree is safe for patients with or without short bowel syndrome?

Research has shown that adding green bean puree to formulas is generally well-tolerated by both infants and adults with short bowel syndrome (SBS). Studies have found that it can help soften stools. In infants with intestinal problems, including SBS, adding green beans improved stool patterns.

For adults with SBS, adding fiber from green beans has been linked to better tolerance of tube feeding. One study in children with SBS found that switching to a diet that includes green beans improved their nutrition and stool patterns.

Overall, these findings suggest that green bean puree can be a safe and helpful addition to the diet for those with SBS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Short Bowel Syndrome (SBS) that often involve complex dietary adjustments and medications to manage symptoms, this approach introduces green bean puree directly into the enteral nutrition formula. This method not only provides a natural source of fiber but also aims to enhance nutrient absorption and improve gut function by gradually increasing the puree concentration over three weeks. Researchers are excited because this simple, food-based intervention could offer a more accessible and potentially effective way to manage SBS, leveraging the natural benefits of green beans to support digestive health.

What evidence suggests that green bean puree might be an effective treatment for short bowel syndrome?

Research has shown that adding green bean puree to baby formula can soften stools for infants, with 56% experiencing this change. This trial will explore the effects of green bean puree in two groups: one with short bowel syndrome (SBS) and a control group without SBS. The fiber in green beans might help adults with SBS better tolerate tube feeding. Although more research is needed, these early findings suggest that green bean puree could help manage some symptoms of SBS by easing digestion. ^{1 2 3 4 6}

Who Is on the Research Team?

Wenjing Zong, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Short Bowel Syndrome (SBS) who are patients at UTSW outpatient clinics. They must have a history of SBS, confirmed by surgery or imaging, and their small bowel should be connected to some part of the colon without an ileocecal valve. Healthy controls without intestinal issues can also join if they consume minimal fiber and get most calories from non-fiber oral or tube feedings.

Inclusion Criteria

I have never had intestinal diseases.

At least 20% calories from fiber-free formula taken orally or via tube

Actively follows at UTSW outpatient clinics

Exclusion Criteria

My calorie intake from food or feeding tubes changed by more than 5%.

I have a pre-existing intestinal disease.

Primary physician does not think fiber supplementation is appropriate clinically

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are initiated on green bean purees added to enteral formula recipes, with increasing amounts over 3 weeks

3 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including microbiome and metabolome analysis

3 weeks-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Green bean puree

Trial Overview

The study tests how well people with SBS tolerate green bean puree as a source of dietary fiber compared to those without SBS. It looks at gastrointestinal symptoms, changes in gut bacteria, and metabolites produced by the body after eating the puree.

How Is the Trial Designed?

Group I: Short Bowel Syndrome Arm Experimental Treatment 1 Intervention

Patients with SBS will be initiated on green bean purees added to enteral formula recipes, based on kilocalories of enteral formula over 3 weeks. During week 1 subjects will prepare and add 50 mL green bean puree per 1000kcal of enteral feed (5%) to their formula mixture, increasing to 100ml (10%) and 150ml (15%) during weeks 2 and 3, respectively.

Group II: Control Arm Active Control 1 Intervention

Patients without SBS will be initiated on green bean purees added to enteral formula recipes, based on kilocalories of enteral formula over 3 weeks. During week 1 subjects will prepare and add 50 mL green bean puree per 1000kcal of enteral feed (5%) to their formula mixture, increasing to 100ml (10%) and 150ml (15%) during weeks 2 and 3, respectively.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

A study of a Middle American diversity panel of common beans revealed that colored bean seeds, particularly black beans, have higher levels of insoluble dietary fibers and certain antinutritional oligosaccharides, which can impact health positively.

Recent cultivars released since 1997 show increased dietary fiber content, suggesting that breeding efforts have successfully enhanced the nutritional profile of common beans, which could help in reducing chronic diseases like obesity and type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic Architecture of Dietary Fiber and Oligosaccharide Content in a Middle American Panel of Edible Dry Bean. Moghaddam, SM., Brick, MA., Echeverria, D., et al.[2018]

A review of 117 adverse drug reactions (ADRs) related to avocado-soybean unsaponifiables (ASU) in France revealed that 35.9% of these reactions were serious, leading to hospitalization, but no deaths were reported.

The most common ADRs included skin reactions (32.5%), liver issues (16.2%), and gastrointestinal problems (12%), with symptoms often resolving quickly after stopping ASU, indicating a need for careful monitoring despite the low incidence of reported ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Post-marketing safety profile of avocado-soybean unsaponifiables]. Olivier, P., Montastruc, JL.[2023]

Consuming pinto beans daily for 12 weeks significantly lowered total cholesterol levels by about 8% in healthy adults and 4% in those with premetabolic syndrome, indicating a positive effect on heart health.

While bean consumption increased the production of beneficial short-chain fatty acids (SCFAs) like propionate during in vitro fermentation, it did not show clear benefits for reducing colon cancer risk, as it lowered certain other SCFAs and affected only one bacterial population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pinto bean consumption changes SCFA profiles in fecal fermentations, bacterial populations of the lower bowel, and lipid profiles in blood of humans. Finley, JW., Burrell, JB., Reeves, PG.[2023]

Short bowel syndrome (SBS) leads to serious complications like malabsorption and malnutrition due to significant loss of small intestine function, often requiring individualized nutritional support.

Recent outcomes suggest that bowel transplantation (BT) may be the preferred treatment for patients with irreversible intestinal failure, as it offers a higher chance of achieving complete digestive autonomy compared to long-term parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Short bowel: from resection to transplantation]. Rodríguez-Montes, JA.[2016]

In a study of 58 pediatric patients with short bowel syndrome (SBS), those who received blenderized feeds showed improved gastrointestinal symptoms, particularly reduced diarrhea, although they experienced increased gas.

Patients with colonic resection were more likely to discontinue blenderized feeds, and a subgroup of patients who lost weight despite improved diarrhea often had a history of ileocecal valve and colonic resection, suggesting that careful management and titration of these feeds may be necessary for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blenderized enteral nutrition in pediatric short gut syndrome: Tolerance and clinical outcomes. Zong, W., Troutt, R., Merves, J.[2023]

The novel triple tube enteral feeding technique used in 10 neonates with short bowel syndrome (SBS) after extensive bowel resection proved to be a safe and effective method for providing nutrition, eliminating the need for costly total parenteral nutrition.

Despite some surgery-related complications, the technique facilitated weight gain during refeeding, with an average gain of 3 to 6 g/kg per day over a follow-up period of 12 months, indicating its potential for enhancing intestinal adaptation in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triple tube therapy: a novel enteral feeding technique for short bowel syndrome in low-income countries. Pratap, A., Kaur, N., Shakya, VC., et al.[2007]

Cholylsarcosine significantly improved fat absorption in short bowel syndrome patients, increasing daily fat absorption by 44% and providing an additional 261 kcal/day, while also allowing three patients to gain weight without worsening diarrhea.

In contrast, natural conjugated bile acids reduced steatorrhea but led to a significant increase in diarrhea, indicating that cholylsarcosine is a safer and more effective option for enhancing nutritional status in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjugated bile acid replacement therapy in short bowel syndrome patients with a residual colon. Kapral, C., Wewalka, F., Praxmarer, V., et al.[2017]

Citations

1.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/1941406412469403

Adding Dietary Green Beans to Formula Resolves the ...

After the addition of the dietary green beans to their formula, all infants had improvements in stool consistency: 56% of the infants had mushy/soft stools, and ...

2.

researchgate.net

researchgate.net/publication/258127729_Adding_Dietary_Green_Beans_to_Formula_Resolves_the_Diarrhea_Associated_With_a_Bowel_Resection_in_Neonates

Adding Dietary Green Beans to Formula Resolves the ...

After the addition of the dietary green beans to their formula, all infants had improvements in stool consistency: 56% of the infants had mushy/ ...

3.

withpower.com

withpower.com/trial/fiber-food-introduction-for-short-bowel-syndrome-73b13

Fiber Food Introduction for Short Bowel Syndrome

Green bean puree is unique for short bowel syndrome as it introduces dietary fiber in a pureed form, which may be easier to digest and absorb for patients with ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/16306306/

Adding dietary green beans resolves the diarrhea ...

It has been shown that, in adults with short bowel syndrome, providing dietary fiber can improve tolerance to enteral feeding. There are no published ...

5.

nutricialearningcenter.com

nutricialearningcenter.com/globalassets/pdfs/gi-allergy/sbs-webinarslides_cohran_9.24.pdf

Short Bowel Syndrome

SBS outcomes. 30 children with SBS studied retrospectively. Results ... ▫Stage 2 green beans to every 8 ounces of 30 kcal/oz formula.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9283279/

Blenderized Enteral Nutrition in Pediatric Short Gut ...

One study of pediatric patients with SBS demonstrated favorable outcomes in tolerance and stool pattern with transition to a blenderized diet.