60 Participants Needed

Fiber Food Introduction for Short Bowel Syndrome

(GREENBEANS Trial)

Recruiting at 1 trial location
WZ
Overseen ByWenjing Zong, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Green bean puree for Short Bowel Syndrome?

There is limited direct evidence for green bean puree in short bowel syndrome, but blenderized feeds, which include whole food components like green beans, are emerging as a preferred approach for enteral nutrition in these patients, suggesting potential benefits.12345

Is green bean puree safe for human consumption?

Green beans can cause allergic reactions in some people, including reactions from eating, touching, or inhaling steam from cooking them. These reactions are due to a specific protein in green beans that can trigger allergies.678910

How does green bean puree treatment for short bowel syndrome differ from other treatments?

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 compromised intestines. Unlike other treatments that might focus on medication or supplements, this approach uses a natural food source to potentially improve gut health and nutrient absorption.1112131415

What is the purpose of this trial?

Short bowel syndrome (SBS) is a rare but challenging condition in which patients have insufficient bowel length to meet fluid, electrolyte, and nutrient requirements without parenteral support.The purpose of this study is to determine how well dietary fiber is tolerated in patients with or without short bowel syndrome based on assessment of gastrointestinal symptoms, weight, and corresponding changes in microbiome composition and metabolomics.

Research Team

WZ

Wenjing Zong, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

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
See 6 more

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
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Short Bowel Syndrome ArmExperimental Treatment1 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 ArmActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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.
[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.
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.
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]

References

[Short bowel: from resection to transplantation]. [2016]
Effect of high dose growth hormone with glutamine and no change in diet on intestinal absorption in short bowel patients: a randomised, double blind, crossover, placebo controlled study. [2019]
Blenderized enteral nutrition in pediatric short gut syndrome: Tolerance and clinical outcomes. [2023]
Triple tube therapy: a novel enteral feeding technique for short bowel syndrome in low-income countries. [2007]
Conjugated bile acid replacement therapy in short bowel syndrome patients with a residual colon. [2017]
Green bean (Phaseolus vulgaris): a new source of IgE-binding lipid transfer protein. [2010]
Green bean hypersensitivity: an occupational allergy in a homemaker. [2019]
Modification of physicochemical, functional properties, and digestibility of macronutrients in common bean (Phaseolus vulgaris L.) flours by different thermally treated whole seeds. [2022]
Identification and characterization of the major allergen of green bean (Phaseolus vulgaris) as a non-specific lipid transfer protein (Pha v 3). [2018]
[Post-marketing safety profile of avocado-soybean unsaponifiables]. [2023]
The Effect of a Diet Containing Extruded Faba Bean Seeds on Growth Performance and Selected Microbial Activity Indices in the Large Intestine of Piglets. [2021]
Influence of a natural-ingredient diet containing Phaseolus vulgaris on the colonization by segmented, filamentous bacteria of the small bowel of mice. [2007]
13.United Statespubmed.ncbi.nlm.nih.gov
Genetic Architecture of Dietary Fiber and Oligosaccharide Content in a Middle American Panel of Edible Dry Bean. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Effect of short-term consumption of yellow peas as noodles on the intestinal environment: A single-armed pre-post comparative pilot study. [2023]
15.United Statespubmed.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. [2023]
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