Short Gut SyndromeGREENBEANSNCT06240065
Successful Fiber Food Introduction in Short Bowel Syndrome
A study testing Green bean puree in people with Short Gut Syndrome, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Gut Syndrome
- What is being tested?
- Green bean puree
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Actively follows at UTSW outpatient clinics
- SBS arm specific: History of SBS diagnosis. History of short bowel syndrome based on surgical/imaging records. Small bowel is in continuity with some portion of colon
- Control arm specific: No history of intestinal pathologies
- No or negligible amount (few bites of fiber-containing foods okay) of fiber in tube feeds or by mouth at baseline
- Less than 20% calories from oral food not containing fiber while the other 80% may be by enteral and/or parenteral feedings
- At least 20% calories from fiber-free formula taken orally or via tube
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- Antibiotic use is allowed, however, should be on a stable regimen of antibiotics starting from 2 weeks prior to intervention until end of study or end of week 3 whichever is sooner
- Previous history of fiber introduction failure is acceptable as long as clinically stable at the time of recruitment
- Fiber supplementation is appropriate per primary physician
Who cannot join
- SBS Arm specific: No diagnosis of SBS.
- Control Arm specific: has baseline intestinal diseases
- Small bowel and colon not in continuity (Ex: presence of ileostomy or jejunostomy)
- >5% changes in percentage of calories from PO, EN and/or PN during the intervention
- Addition/discontinuation/significant alteration to antibiotics regimen during study period
- Primary physician does not think fiber supplementation is appropriate clinically
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Children's Medical Center
Dallas, Texas, 75390
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
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.
Read the detailed description
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 goal of SBS treatment is to achieve enteral autonomy using strategies that optimize intestinal absorption while minimizing unpleasant gastrointestinal (GI) side effects. One strategy that has emerged is the addition of soluble fiber to enteral formula, and this strategy has gained popularity in clinical practice as fiber-rich formulas comprised of blenderized whole foods have become commercially available. However, the investigators' preliminary observations suggest that patients with SBS have variable tolerance and growth outcomes on these blenderized feeds. To date, there are no clinical studies documenting the effects of dietary fiber in SBS patients and guidance in enteral nutrition advancement is lacking in this medically complex population. The current study aims to explore the tolerance of controlled fiber addition to enteral formula based on assessment of GI symptoms, and corresponding changes in microbiome composition, and metabolomics in pediatric patients with SBS versus non-SBS controls. The investigators will use a practical approach with fiber introduction and slowly advance to goal fiber intake to understand the factors leading to continuation. Stool, urine, and plasma samples collected pre- and post- intervention will help identify biomarkers that would predict successful fiber tolerance and optimize selection of patients for fiber introduction. While there is no intent to treat, mitigate, prevent, diagnose or cure the symptoms of SBS, the study may help shed light on the underlying mechanism for intolerance to dietary fiber.
- Conditions
- Short Gut Syndrome
- Being tested
- Green bean puree
- Keywords
- nutrition, fiber, sbs, microbiome, metabolome
- Medical subject headings
- Short Bowel Syndrome, MYH9-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green bean pureeOther
Green bean puree as a proxy for fiber-foods
| Study group | Role | What they receive |
|---|---|---|
| Short Bowel Syndrome Arm | Experimental | 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. Receives: Other: Green bean puree |
| Control Arm | Active comparator | 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. Receives: Other: Green bean puree |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical tolerance
To assess the rate of clinical intolerance leading to discontinuation of green beans and symptoms/signs associated with discontinuation of fiber addition in SBS vs controls (no score/scale will be used)
Measured: 3 weeks-6 months
Secondary outcomes (1)
Microbiome/Metabolome Analysis
To assess the correlation between clinical tolerance of fiber and microbiome/metabolome changes in SBS vs controls
Measured: 3 weeks-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start19 Apr 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Gut SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Wenjing Zong, University of Texas Southwestern Medical Center
- Investigators
- Wenjing Zong, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240065
- Sponsor's protocol ID
- STU-2023-1152
- Acronym
- GREENBEANS
- Status last verified
- Nov 2025
- First submitted
- 25 Jan 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Fiber Food Introduction in Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06240065
- Acronym / sponsor ID
- GREENBEANS / STU-2023-1152
- Conditions
- Short Gut Syndrome
- Keywords
- nutrition, fiber, sbs, microbiome, metabolome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 goal of SBS treatment is to achieve enteral autonomy using strategies that optimize intestinal absorption while minimizing unpleasant gastrointestinal (GI) side effects. One strategy that has emerged is the addition of soluble fiber to enteral formula, and this strategy has gained popularity in clinical practice as fiber-rich formulas comprised of blenderized whole foods have become commercially available. However, the investigators' preliminary observations suggest that patients with SBS have variable tolerance and growth outcomes on these blenderized feeds. To date, there are no clinical studies documenting the effects of dietary fiber in SBS patients and guidance in enteral nutrition advancement is lacking in this medically complex population. The current study aims to explore the tolerance of controlled fiber addition to enteral formula based on assessment of GI symptoms, and corresponding changes in microbiome composition, and metabolomics in pediatric patients with SBS versus non-SBS controls. The investigators will use a practical approach with fiber introduction and slowly advance to goal fiber intake to understand the factors leading to continuation. Stool, urine, and plasma samples collected pre- and post- intervention will help identify biomarkers that would predict successful fiber tolerance and optimize selection of patients for fiber introduction. While there is no intent to treat, mitigate, prevent, diagnose or cure the symptoms of SBS, the study may help shed light on the underlying mechanism for intolerance to dietary fiber.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Bowel Syndrome Arm | Experimental | Other: Green bean pureePatients 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. |
| Control Arm | Active comparator | Other: Green bean pureePatients 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 may qualify
- Ages
- 4 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Actively follows at UTSW outpatient clinics
- SBS arm specific: History of SBS diagnosis. History of short bowel syndrome based on surgical/imaging records. Small bowel is in continuity with some portion of colon
- Control arm specific: No history of intestinal pathologies
- No or negligible amount (few bites of fiber-containing foods okay) of fiber in tube feeds or by mouth at baseline
- Less than 20% calories from oral food not containing fiber while the other 80% may be by enteral and/or parenteral feedings
Key exclusion criteria (6 listed)
- SBS Arm specific: No diagnosis of SBS.
- Control Arm specific: has baseline intestinal diseases
- Small bowel and colon not in continuity (Ex: presence of ileostomy or jejunostomy)
- >5% changes in percentage of calories from PO, EN and/or PN during the intervention
- Addition/discontinuation/significant alteration to antibiotics regimen during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green bean pureeGreen bean puree as a proxy for fiber-foods | Other | Control Arm, Short Bowel Syndrome Arm |
Primary outcome
Clinical tolerance
Time frame: 3 weeks-6 months
To assess the rate of clinical intolerance leading to discontinuation of green beans and symptoms/signs associated with discontinuation of fiber addition in SBS vs controls (no score/scale will be used)
1 secondary outcome
Microbiome/Metabolome Analysis
Time frame: 3 weeks-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Short Gut Syndrome
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Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
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Registry for Participants With Short Bowel Syndrome
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A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenjing Zong, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green bean puree in people with Short Gut Syndrome, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical tolerance (time frame: 3 weeks-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.