Dietary Fiber for Short Bowel Syndrome

Overseen By Lindsey Albenberg, DO

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

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 explores the effects of adding dietary fiber, specifically from green bean puree, on individuals with and without short bowel syndrome (SBS). SBS occurs when the intestine is too short to absorb nutrients properly, often necessitating additional nutrition support. The study aims to assess fiber tolerance in people with SBS and its impact on gut health. Individuals who receive outpatient care at the Children's Hospital of Philadelphia and primarily rely on tube feeding with minimal fiber intake may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to enhance understanding of dietary fiber's impact 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 short bowel syndrome?

Research has shown that green bean puree might be safe and easy to digest for people with short bowel syndrome (SBS). In studies, adding green beans to baby formula improved stool consistency in infants with intestinal problems. For example, many babies had softer stools after consuming green beans, suggesting the puree aids digestion.

In another study, adults with SBS who consumed foods with dietary fiber, such as green bean puree, found tube feeding easier to manage. This allowed them to handle their nutrition more comfortably. The puree provides dietary fiber in a form that's easier to digest and absorb, which could benefit those with SBS.

Overall, these findings suggest that green bean puree is a promising and safe option for people with short bowel syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Short Bowel Syndrome, which often involve medications to slow down digestion or surgeries to lengthen the bowel, this approach uses green bean puree as a dietary fiber supplement. Researchers are excited about this treatment because it's a natural, food-based solution that integrates easily into patients' existing enteral feeding routines. By gradually increasing the amount of green bean puree, the method aims to enhance nutrient absorption and digestion without relying on drugs or invasive procedures. This unique approach could offer a gentler and more accessible option for managing Short Bowel Syndrome.

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

This trial will evaluate the effects of adding green bean puree to the diet of patients with short bowel syndrome (SBS). Research has shown that green bean puree can improve stool consistency. One study found that infants with SBS had softer and easier-to-manage stools when green beans were mixed into their formula. Green bean puree offers dietary fiber in an easily digestible form, which is crucial for people with SBS. Patients generally tolerate it well and experience improved stool patterns when they include green bean puree in their diet. This suggests that green bean puree might help manage some symptoms of SBS by supporting digestion and nutrient absorption. ^{1 2 3 6 7}

Who Is on the Research Team?

Christina Bales, MD

Principal Investigator

Children's Hospital of Philadelphia

Lindsey Albenberg, DO

Principal Investigator

Children's Hospital of Philadelphia

Wenjing Zong, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children with Short Bowel Syndrome (SBS) who get most of their nutrition through special formulas without fiber, and a control group without intestinal issues. Participants should be stable on antibiotics if used, and SBS patients must have had part of their bowel removed but still connected to some colon.

Inclusion Criteria

Actively follows at the Children's Hospital of Philadelphia (CHOP) outpatient clinics

I have been on a stable antibiotic regimen for at least 2 weeks.

I have a history of short bowel syndrome, had part of my intestine removed, and still have some of my colon connected.

Exclusion Criteria

My small bowel and colon are not connected due to a stoma.

>5% changes in percentage of calories from oral nutrition, enteral nutrition, and/or parenteral nutrition during the intervention

I have never been diagnosed with Short Bowel Syndrome and have not had surgery to remove part of my intestine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive green bean purees added to enteral formula recipes over 3 weeks, with increasing amounts each week.

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of GI symptoms and microbiome/metabolome changes.

3 weeks-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Green bean puree

Trial Overview The study tests how green bean puree affects kids with SBS compared to healthy controls. It looks at gastrointestinal symptoms, changes in gut bacteria, and metabolites to see if dietary fiber is tolerated differently between the two groups.

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?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

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]

Frequent and long-term consumption of legume seeds, like red kidney beans, significantly increases dietary fiber intake, leading to greater fecal output and higher concentrations of volatile fatty acids (VFA) in feces.

Despite no differences in colonic function between habitual and infrequent legume consumers, the addition of beans to both diets improved colonic health by providing beneficial fiber and influencing fecal characteristics positively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of frequent and long-term bean consumption on colonic function and fermentation. Fleming, SE., O'Donnell, AU., Perman, JA.[2018]

Both whole brown beans and isolated bean dietary fiber can help reduce the amount of atherosclerotic plaque in Apoe-/- mice on high-fat diets, although they did not significantly lower plasma lipid levels.

The whole bean diet increased gut microbiota diversity and altered the composition of gut bacteria, leading to higher production of beneficial short-chain fatty acids (SCFAs), which are important for gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Whole Brown Bean and Its Isolated Fiber Fraction on Plasma Lipid Profile, Atherosclerosis, Gut Microbiota, and Microbiota-Dependent Metabolites in Apoe-/- Mice. Liu, J., Hefni, ME., Witthöft, CM., et al.[2022]

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]

A survey of 94 healthcare professionals revealed that pectin is the most commonly used fiber supplement for managing chronic high stool output in pediatric short bowel syndrome (SBS).

Key factors influencing the initiation and discontinuation of fiber therapy include stool consistency and volume, with many providers discontinuing treatment within 2 weeks if no improvement is observed, particularly due to abdominal distention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble Fiber Use in Pediatric Short Bowel Syndrome: A Survey on Prevailing Practices. Harvie, ML., Norris, MAT., Sevilla, WMA.[2018]

In a study using C57BL/6 mice, diets containing navy or black bean flour reduced inflammatory cytokines and oxidative stress during acute colitis, suggesting a potential anti-inflammatory effect.

However, these bean diets also increased colonic damage and apoptosis, indicating that while they may help reduce inflammation, they could also worsen mucosal injury in the context of colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooked navy and black bean diets improve biomarkers of colon health and reduce inflammation during colitis. Zhang, C., Monk, JM., Lu, JT., et al.[2020]

Dry edible beans are a valuable source of both protein and dietary fiber, with a favorable ratio of these nutrients, yet consumer awareness of this benefit is low.

Research on 275 different bean cultivars showed that they contain significant amounts of soluble, insoluble, and oligosaccharide fiber, suggesting that specific labeling could enhance consumer understanding of their nutritional value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dry Bean: A Protein-Rich Superfood With Carbohydrate Characteristics That Can Close the Dietary Fiber Gap. Brick, MA., Kleintop, A., Echeverria, D., et al.[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]

A study of diverse dry bean cultivars revealed significant genetic variation in dietary fiber content, with total dietary fiber ranging from 20.0% to 27.0% in one population and 20.6% to 25.7% in another, indicating potential for breeding improved varieties.

The modified AOAC 2011.25 method used in this research effectively quantified dietary fiber and oligosaccharides in cooked dry beans, supporting its suitability for future studies on dietary fiber in legumes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of the AOAC 2011.25 integrated total dietary fiber assay to determine the dietary fiber and oligosaccharide content of dry edible beans. Kleintop, AE., Echeverria, D., Brick, LA., et al.[2017]

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 involving 160 male obese mice, diets containing cooked navy beans significantly reduced the incidence of colon cancer lesions compared to a control diet, with reductions of up to 91% for adenomas and adenocarcinomas.

Both the soluble and insoluble fractions of cooked navy beans contributed to their cancer-preventive effects, indicating that consuming whole beans may provide multiple protective benefits against colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary cooked navy beans and their fractions attenuate colon carcinogenesis in azoxymethane-induced ob/ob mice. Bobe, G., Barrett, KG., Mentor-Marcel, RA., et al.[2021]

High consumption of common beans is linked to a lower risk of cancer and chronic diseases, supported by studies showing their health benefits in both human populations and animal models.

The non-digestible compounds in common beans, such as fiber and phytochemicals, may inhibit cancer cell growth and promote cell death, suggesting they play a protective role against cancer through gene and protein modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Beans and Their Non-Digestible Fraction: Cancer Inhibitory Activity-An Overview. Campos-Vega, R., Oomah, BD., Loarca-Piña, G., et al.[2020]

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. journals.sagepub.com journals.sagepub.com/doi/pdf/10.1177/1941406412469403

Adding Dietary Green Beans to Formula Resolves the ... Infants with IF or SBS had improved stool consistency after dietary green beans were added to their formulas. Although the addition of dietary green beans did ...

5. 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.

6. 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 ...

7. 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.