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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Le Bonheur Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Tennessee Health Science Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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