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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 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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER

2,005 Previous Clinical Trials

42,882,173 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,582,760 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor recruiting participants at present?

"Indeed, the information available on clinicaltrials.gov verifies that this medical trial is actively enrolling eligible participants. The study was posted on May 8th 2022 and recently updated on June 26th 2022; 60 patients have to be sourced from a single site for inclusion in the research."

Answered by AI

May I be a candidate for this research?

"This medical trial is recruiting sixty individuals between 4 months and 18 years old with short gut syndrome. To be eligible, patients must have had an ileocecal resection procedure or imaging records that prove the presence of this condition; not more than 20% of their daily calorie intake should come from fiber-lacking sources (with only a few bites of fibre containing foods allowed); they may use antibiotics as long as it's part of a stable regimen starting 2 weeks before the intervention until study end/week 3; previous history of unsuccessful dietary fibres introduction is okay if clinically steady at recruitment time. Additionally, those in control arm should"

Answered by AI

Does this research involve participants aged eighty-five and over?

"This trial's eligibility criteria necessitate that participants be between 4 Months and 18 years old. Clinicaltrials.gov currently lists 378 studies for patients in this age bracket and 986 studies available to those over 65."

Answered by AI

What is the current size of this clinical trial's participant pool?

"Affirmative. Per the information available on clinicaltrials.gov, enrollment is open for this medical experiment which was first advertised on May 8th 2022 and most recently updated June 26th 2022. The trial requires 60 participants to be sourced from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fiber Food Introduction in Pediatric Short Bowel Syndrome

Wenjing Zong 2022. "Fiber Food Introduction in Pediatric Short Bowel Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05432648.