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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks-6 months
Awards & highlights

Study Summary

This trial will help researchers understand if dietary fiber is a safe and effective treatment for short bowel syndrome.

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.Check my eligibility
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.See study design
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
Select...
I have a history of short bowel syndrome, had part of my intestine removed, and still have some of my colon connected.
Select...
I have never had any intestinal diseases.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symptoms
Secondary outcome measures
Microbiome/Metabolome Changes

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.

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?

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
2,027 Previous Clinical Trials
42,886,038 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
712 Previous Clinical Trials
8,590,216 Total Patients Enrolled
3 Trials studying Short Bowel Syndrome
76 Patients Enrolled for Short Bowel Syndrome
Lindsey Albenberg, DOPrincipal InvestigatorChildren's Hospital of Philadelphia
3 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Green bean puree (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05432648 — N/A
Short Bowel Syndrome Research Study Groups: Short Bowel Syndrome Arm, Control Arm -
Short Bowel Syndrome Clinical Trial 2023: Green bean puree Highlights & Side Effects. Trial Name: NCT05432648 — N/A
Green bean puree (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05432648 — N/A
~19 spots leftby Jun 2025