NCT04224168

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 8, 2020

Last Update Submit

January 9, 2020

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

  • Weight gain

    Z-score will be used to evaluate overall weight gain. This will standardize weight between ages. Weight will be taken prior to intervention and after each intervention.

    6 months

  • Stooling pattern

    Will use postcards to characterize stooling consistency and amount of stool. They will be weekly postcards that are mailed back to the clinic. Will take the average consistency and amount each week and compare before and after each intervention.

    6 months

Study Arms (2)

Green Beans

EXPERIMENTAL

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.

Dietary Supplement: Green Beans

Liquid Pectin

EXPERIMENTAL

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.

Dietary Supplement: Liquid Pectin

Interventions

Green BeansDIETARY_SUPPLEMENT

Please see arm group Green beans for description

Green Beans
Liquid PectinDIETARY_SUPPLEMENT

Please see arm group liquid pectin for description

Liquid Pectin

Eligibility Criteria

Age6 Months - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (11)

  • Goulet O, Olieman J, Ksiazyk J, Spolidoro J, Tibboe D, Kohler H, Yagci RV, Falconer J, Grimble G, Beattie RM. Neonatal short bowel syndrome as a model of intestinal failure: physiological background for enteral feeding. Clin Nutr. 2013 Apr;32(2):162-71. doi: 10.1016/j.clnu.2012.09.007. Epub 2012 Sep 25.

    PMID: 23159212BACKGROUND

  • Drenckpohl, D., et al., Adding Dietary Green Beans to Formula Resolves the Diarrhea Associated With a Bowel Resection in Neonates. ICAN: Infant, Child, & Adolescent Nutrition, 2013. 5(1): p. 8-13.

    BACKGROUND

  • Wessel J, Kotagal M, Helmrath MA. Management of Pediatric Intestinal Failure. Adv Pediatr. 2017 Aug;64(1):253-267. doi: 10.1016/j.yapd.2017.03.010. No abstract available.

    PMID: 28688591BACKGROUND

  • Rabbani GH, Teka T, Zaman B, Majid N, Khatun M, Fuchs GJ. Clinical studies in persistent diarrhea: dietary management with green banana or pectin in Bangladeshi children. Gastroenterology. 2001 Sep;121(3):554-60. doi: 10.1053/gast.2001.27178.

    PMID: 11522739BACKGROUND

  • Harvie ML, Norris MAT, Sevilla WMA. Soluble Fiber Use in Pediatric Short Bowel Syndrome: A Survey on Prevailing Practices. Nutr Clin Pract. 2018 Aug;33(4):539-544. doi: 10.1002/ncp.10089. Epub 2018 May 16.

    PMID: 29767462BACKGROUND

  • Drenckpohl D, Hocker J, Shareef M, Vegunta R, Colgan C. Adding dietary green beans resolves the diarrhea associated with bowel surgery in neonates: a case study. Nutr Clin Pract. 2005 Dec;20(6):674-7. doi: 10.1177/0115426505020006674.

    PMID: 16306306BACKGROUND

  • Homann HH, Kemen M, Fuessenich C, Senkal M, Zumtobel V. Reduction in diarrhea incidence by soluble fiber in patients receiving total or supplemental enteral nutrition. JPEN J Parenter Enteral Nutr. 1994 Nov-Dec;18(6):486-90. doi: 10.1177/0148607194018006486.

    PMID: 7602722BACKGROUND

  • Becker B, Kuhn U, Hardewig-Budny B. Double-blind, randomized evaluation of clinical efficacy and tolerability of an apple pectin-chamomile extract in children with unspecific diarrhea. Arzneimittelforschung. 2006;56(6):387-93. doi: 10.1055/s-0031-1296739.

    PMID: 16889120BACKGROUND

  • Koruda MJ, Rolandelli RH, Settle RG, Saul SH, Rombeau JL. Harry M. Vars award. The effect of a pectin-supplemented elemental diet on intestinal adaptation to massive small bowel resection. JPEN J Parenter Enteral Nutr. 1986 Jul-Aug;10(4):343-50. doi: 10.1177/0148607186010004343.

    PMID: 3747092BACKGROUND

  • Rabbani GH, Teka T, Saha SK, Zaman B, Majid N, Khatun M, Wahed MA, Fuchs GJ. Green banana and pectin improve small intestinal permeability and reduce fluid loss in Bangladeshi children with persistent diarrhea. Dig Dis Sci. 2004 Mar;49(3):475-84. doi: 10.1023/b:ddas.0000020507.25910.cf.

    PMID: 15139502BACKGROUND

  • Nakao M, Ogura Y, Satake S, Ito I, Iguchi A, Takagi K, Nabeshima T. Usefulness of soluble dietary fiber for the treatment of diarrhea during enteral nutrition in elderly patients. Nutrition. 2002 Jan;18(1):35-9. doi: 10.1016/s0899-9007(01)00715-8.

    PMID: 11827762BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anushree Algotar, MBBS

    LeBonheur Children's Hospital

    STUDY CHAIR

Central Study Contacts

Meredith L Harvie, MD

CONTACT

901-287-7337mharvie@uthsc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)