Pectin Use in Pediatric Intestinal Rehabilitation

Short Bowel Syndrome Clinical Trial

— PUPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224168
• Other study ID #: 19-06654-FB
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 2021

Study information

• Verified date: January 2020
• Source: Le Bonheur Children's Hospital
• Contact: Meredith L Harvie, MD
• Phone: 901-287-7337
• Email: mharvie[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Green Beans
Please see arm group Green beans for description
• Liquid Pectin
Please see arm group liquid pectin for description

Locations

Country	Name	City	State
United States	Le Bonheur Children's Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital	University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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.

Goulet O, Olieman J, Ksiazyk J, Spolidoro J, Tibboe D, Köhler 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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