Pectin Use in Pediatric Intestinal Rehabilitation

NCT ID: NCT04224168

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-01-31

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.

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.

Conditions

Short Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Green Beans

Intervention Type: DIETARY_SUPPLEMENT

Please see arm group Green beans for description

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.

Group Type: EXPERIMENTAL

Liquid Pectin

Intervention Type: DIETARY_SUPPLEMENT

Please see arm group liquid pectin for description

Interventions

Green Beans

Please see arm group Green beans for description

Intervention Type: DIETARY_SUPPLEMENT

Liquid Pectin

Please see arm group liquid pectin for description

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee

OTHER

Sponsor Role: collaborator

Le Bonheur Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Meredith L Harvie, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anushree Algotar, MBBS

Role: STUDY_CHAIR

LeBonheur Children's Hospital

Locations

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meredith L Harvie, MD

Role: CONTACT

mharvie@uthsc.edu

901-287-7337

Facility Contacts

Meredith L Harvie, MD

Role: primary

mharvie@uthsc.edu

901-287-7337

References

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Reference Type: BACKGROUND

PMID: 23159212 (View on PubMed)

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.

Reference Type: BACKGROUND

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Other Identifiers

19-06654-FB

Identifier Type: -

Identifier Source: org_study_id