What side effects are associated with this type of intervention?

Dietary fiber is generally well-tolerated in patients with Short Bowel Syndrome, but it can sometimes cause gastrointestinal symptoms such as bloating, gas, and abdominal discomfort. These symptoms are often due to the fermentation of fiber by gut bacteria, which can produce gas and other byproducts. It is important to introduce fiber gradually to minimize these side effects. Other common treatments for SBS, such as parenteral nutrition, can have side effects including infections, liver disease, and metabolic bone disease. Patients should work closely with their healthcare providers to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Short Bowel Syndrome (SBS), including teduglutide (Gattex), which enhances intestinal absorption, and somatropin (Zorbtive), a growth hormone that improves nutrient absorption. These treatments aim to reduce dependence on parenteral nutrition. While dietary fiber is being studied for its impact on gastrointestinal symptoms, microbiome composition, and metabolomics in SBS, it is not yet an FDA-approved treatment specifically for SBS. Current research is exploring how dietary fiber can be integrated into SBS management to improve patient outcomes.

What other types of research exist?

Promising novel alternatives to dietary fiber for Short Bowel Syndrome (SBS) patients include prebiotics, probiotics, and synbiotics. These alternatives can positively impact gastrointestinal symptoms, microbiome composition, and metabolomics. Prebiotics are nondigestible carbohydrates that stimulate beneficial colonic bacteria, while probiotics are live microorganisms that benefit the host. Synbiotics combine both prebiotics and probiotics, potentially offering a more comprehensive approach to modulating the gut microbiota and improving overall gut health.

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Dietary Supplement

Dietary Fiber for Short Bowel Syndrome

N/A

Recruiting

Led By Lindsey Albenberg, DO

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

SBS arm specific: History of SBS diagnosis, ileocecal resection without ICV, small bowel in continuity with some portion of colon

Control arm specific: No history of intestinal pathologies

Must not have

Small bowel and colon not in continuity (e.g., presence of ileostomy or jejunostomy)

SBS Arm specific: No diagnosis of SBS, no history of ICV resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks-6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified for this trial but may include typical reactions to new foods such as gas, bloating or discomfort due to increased fiber intake especially relevant for those with compromised digestive systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have never had any intestinal diseases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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

Select...

I have not changed my antibiotics significantly during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks-6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Symptoms

Secondary study objectives

Microbiome/Metabolome Changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Arm -Active 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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Short Bowel Syndrome (SBS) include parenteral nutrition, enteral nutrition, and dietary modifications. Parenteral nutrition provides essential nutrients directly into the bloodstream, bypassing the digestive system, which is crucial for patients with insufficient bowel length. Enteral nutrition involves feeding through a tube directly into the stomach or small intestine, promoting gut adaptation and function. Dietary fiber, particularly slowly fermentable fibers like psyllium, can improve gastrointestinal symptoms by enhancing stool consistency and promoting beneficial gut microbiota. This is important for SBS patients as it can help manage symptoms, improve nutrient absorption, and reduce dependency on parenteral nutrition.

Probiotics in irritable bowel syndrome: an immunomodulatory strategy?