Successful Fiber Food Introduction in Short Bowel Syndrome

Conditions

• Short Gut Syndrome

Eligibility Criteria

Sex

ALL

Age

4 Months - 17 Years

Healthy Volunteers

Accepted

Interventions

• Green bean puree — OTHER
  Green bean puree as a proxy for fiber-foods

Study Details

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.

Key Dates

Start date

Apr 19, 2024

Status verified

Nov 2025

Primary completion

Apr 30, 2027

Completion

Apr 30, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Short Bowel Syndrome Arm
  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.
• Active Comparator: Control Arm
  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.

Primary Outcome Measure

Clinical tolerance [ Time Frame: 3 weeks-6 months ]

Locations (2)

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