Recruiting

Pectin

Sponsor:

Le Bonheur Children's Hospital

Code:

NCT04224168

Conditions

Short Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Green Beans

Liquid Pectin

Study Details

Brief summary:

Pediatric short bowel patients, age 6 months to 21 years old, followed in our intestinal rehabilitation clinic, will be screened for qualification in the study. If meets qualification, will be consented for the study. The study involves patients receiving green beans in their diet for three months with data collection including stooling patterns as well as labs, and then switching over to liquid pectin for three months. Again data collection will take place. The duration of the study once patient is consented is \~6 months.

Conditions

Short Bowel Syndrome

Study ID

NCT04224168

Start date

Jan 1, 2020

Status verified date

Jan, 2020

Completion date

Jan, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Short bowel syndrome patients followed in CIRCLe
  • >=50% of colon remaining
  • Patients requiring only enteral feeds for nutrition
  • >=6 months of age-21 years of age

Exclusion criteria:

  • Patients with major structural cardiac anomalies and/or end stage renal disease
  • Patients with solid organ transplant
  • Patients >24 months of age without gastric tube
  • Short bowel patients on PN

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Green Beans

Green beans will be provided in the daily diets of the patients enrolled for 3 months via gtube or oral means. Only up to 6g of fiber total from green beans will be given. This equates to 3x 4 ounce jars of green beans per day.

experimental: Liquid Pectin

Liquid pectin will be provided in the daily diets of the patients enrolled for 3 months via gtube or oral means. Only up to 6g of fiber total from liquid pectin will be given. This equates to 6 teaspoons or 30mL of liquid pectin per day.

Interventions

Green Beans

Please see arm group Green beans for description

Liquid Pectin

Please see arm group liquid pectin for description

Primary outcome measure

  • Weight gain [ Time Frame: 6 months ]
  • Stooling pattern [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Meredith L Harvie, MD

901-287-7337mharvie@uthsc.edu

Locations

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Meredith L Harvie, MD

901-287-7337mharvie@uthsc.edu

More Information

Sponsor

Le Bonheur Children's Hospital

Last update posted

Jan 13, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Le Bonheur Children's Hospital on 2020-01-13.