Pectin Use in Pediatric Intestinal Rehabilitation (PUPI)

January 9, 2020 updated by: Meredith L Harvie, MD, Le Bonheur Children's Hospital

Pectin Use in Pediatric Intestinal Rehabilitation: Comparison Study of Liquid Pectin Versus Green Beans in Optimizing Enteral Nutrition in Short Bowel Syndrome Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This will be a modified cross over design. Patients who meet eligibility criteria, will be consented in their standard of care intestinal rehab clinic visit. Due to the fact that some patients who qualify for the study may already be on liquid pectin prior to the study, we will not be able to randomize all of the patients prior to starting the intervention. If a patient is on liquid pectin, they will stay on liquid pectin as their first intervention. If the patient is on no form of daily pectin, they will be randomized to either green beans or liquid pectin first. The patient will either be given Ball real fruit liquid pectin, 1g fiber/tsp, (mixed in formula or other liquid) via oral route or gastric tube (gtube) or Gerber stage two green bean baby food, 2gfiber/jar, via oral route or gtube. We will have patients stay on either Ball real fruit liquid pectin or Gerber stage 2 green beans for three months. After the three-month trial on one of the pectin formulation, they will switch to the other. However, we will not start collecting data until a week after the switch to allow for a washout period without compromising potential benefit that the patient was receiving. Each patient will receive 2g/kg of fiber per day(based on previous case reports) with a max of 6g/day. Patients will be followed in the Children's Intestinal Rehabilitation Clinic at Le Bonheur (CIRCLe). Standard of care follow up for short bowel syndrome patients is three months if they are doing well. During the three months, families will be contacted every 4 weeks via patient portal or phone call to ask specific questions on their current form of pectin, amount, days missed, ease/difficulty of administration and clinical symptoms. This will also serve as a reminder to the parents of what they should be providing to the child and will assist in optimizing data collection. After three months of being on one formulation of pectin, they will change to the other formulation and same follow up will occur. Stool output data collection will be delayed one week in between interventions as detailed above to allow for a "wash out" period. Standard of care also includes lab work (complete metabolic panel, magnesium, phosphorous, triglyceride, complete blood count with differential) at each 3 month visit. Trace minerals and soluble vitamins are usually collected annually, but for this study, will plan to obtain serum copper and iron levels after each intervention(x2). However, additional venous puncture will not be required. Therefore, data can be collected prior to intervention and following each intervention, then be compared between the groups. If able, we will collect stool samples from patients prior to intervention and after intervention to evaluate the microbiome. Recruitment in the study would be for a total period of six months. Interventions would be completed over a six month period. This allows us a total of 12 months for recruitment, intervention and data collection.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: Green Beans
Please see arm group Green beans for description
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.
Dietary supplement: Liquid Pectin
Please see arm group liquid pectin for description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight gain
Time Frame: 6 months
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
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Le Bonheur Children's Hospital

Collaborators

University of Tennessee Health Science Center

Investigators

  • Study Chair: Anushree Algotar, MBBS, LeBonheur Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (ACTUAL)

January 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-06654-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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