Dietary Fiber for Short Bowel Syndrome

Overseen by Christina Bales, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Intestinal diseases, Ileostomy, Jejunostomy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if adding dietary fiber to liquid nutrition helps children with short bowel syndrome (SBS) absorb nutrients better. Researchers will monitor symptoms and gut health to see if the fiber is well-tolerated. The goal is to find out if fiber can improve their condition without causing side effects.

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?

Research suggests that adding fiber to enteral feedings can help manage increased stool output in short bowel syndrome, although there are no standardized guidelines. Blenderized feeds, which include whole food components like green beans, are becoming popular for enteral nutrition, but evidence is still limited. ^{1 2 3 4 5}

Is dietary fiber from beans safe for humans?

Research suggests that beans, which are high in dietary fiber, are generally safe and may even offer health benefits like reducing cancer risk and inflammation. However, specific safety data for green bean puree or similar preparations in humans with short bowel syndrome is limited. ^{1 6 7 8 9}

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

Green bean puree is unique because it provides a natural source of dietary fiber, which can help improve gut health and function. Unlike other treatments that may involve medications or supplements, this approach uses a whole food that is rich in both soluble and insoluble fibers, potentially benefiting digestion and nutrient absorption in a more holistic way. ^{7 10 11 12 13}

Research Team

Lindsey Albenberg, DO

Principal Investigator

Children's Hospital of Philadelphia

Christina Bales, MD

Principal Investigator

Children's Hospital of Philadelphia

Wenjing Zong, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Green bean puree (Dietary Supplement)

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.

Participant Groups

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+

Joseph W. St. Geme III

Children's Hospital of Philadelphia

Chief Medical Officer since 2021

MD, PhD, MPH

Madeline Bell

Children's Hospital of Philadelphia

Chief Executive Officer since 2015

BSc in Nursing from Villanova University, MSc in Organizational Dynamics from the University of Pennsylvania

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Blenderized enteral nutrition in pediatric short gut syndrome: Tolerance and clinical outcomes. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Soluble Fiber Use in Pediatric Short Bowel Syndrome: A Survey on Prevailing Practices. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Conjugated bile acid replacement therapy in short bowel syndrome patients with a residual colon. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Triple tube therapy: a novel enteral feeding technique for short bowel syndrome in low-income countries. [2007]

5. Spain pubmed.ncbi.nlm.nih.gov

[Short bowel: from resection to transplantation]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary cooked navy beans and their fractions attenuate colon carcinogenesis in azoxymethane-induced ob/ob mice. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Genetic Architecture of Dietary Fiber and Oligosaccharide Content in a Middle American Panel of Edible Dry Bean. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Cooked navy and black bean diets improve biomarkers of colon health and reduce inflammation during colitis. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Common Beans and Their Non-Digestible Fraction: Cancer Inhibitory Activity-An Overview. [2020]

10. United States 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. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Influence of frequent and long-term bean consumption on colonic function and fermentation. [2018]

12. Switzerland 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. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Dry Bean: A Protein-Rich Superfood With Carbohydrate Characteristics That Can Close the Dietary Fiber Gap. [2023]