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Dietary Supplement

Fiber Food Introduction for Short Bowel Syndrome (GREENBEANS Trial)

N/A

Waitlist Available

Led By Wenjing Zong, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Control arm specific: No history of intestinal pathologies

SBS arm specific: History of SBS diagnosis. History of short bowel syndrome based on surgical/imaging records. Has ileocecal resection (No ICV) and small bowel is in continuity with some portion of colon

Must not have

SBS Arm specific: No diagnosis of SBS. No history of ICV resection

Control Arm specific: has baseline intestinal diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks-6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see how well patients with short bowel syndrome can tolerate dietary fiber compared to those without the condition. The study will look at gastrointestinal symptoms, changes in gut bacteria, and metabolic processes."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed, potential side effects may include increased gastrointestinal discomfort such as bloating, gas, cramps or diarrhea due to introducing fiber into the diet.

Eligibility Criteria

Inclusion Criteria

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

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I have never had intestinal diseases.

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I have a history of short bowel syndrome and have had surgery to remove part of my intestine.

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I get less than 20% of my calories from solid food.

Exclusion Criteria

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

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I have never been diagnosed with short bowel syndrome (SBS) or had a part of my intestine removed.

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I have a pre-existing intestinal disease.

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

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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

Clinical tolerance

Secondary study objectives

Microbiome/Metabolome Analysis

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 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.

0 / 7Eligibility criteria met