Improved Quality of Life in Children With Intestinal Failure

NCT04981262 | Completed

• 1 other identifier: 170851
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Children with intestinal failure have a lack of tolerance for food in the intestine. The children are dependent on intravenous nutrition over a long period of time period to ensure growth and development. The condition is characterized by bacterial overgrowth in the intestine, with nausea, vomiting, diarrhea and flatulence as physical symptoms. Mental health is affected in the form of lower quality of life, lack of school participation and less social contact with peers. The investigators own (unpublished) data show that children with intestinal failure have a lower quality of life than healthy people. Standard treatment is antibiotics, but the effect of these is short-lived, and many must have repeated courses. Prebiotics are indigestible carbohydrates (fiber) in foods that positively affect the bacterial flora and promote intestinal health. In this project the investigators want to see if supply of prebiotics can change the bacterial balance, reduce symptoms of bacterial overgrowth and increase quality of life. The study is unique, as Prebiotics have not previously been used in the treatment of intestinal failure. If successful, it can pave the way for a new and better treatment method that can potentially be transferred to other conditions with imbalance in the intestinal flora. The study is a randomized intervention study and is consist of two phases. In phase 1, the effect of 4 weeks of open intervention with prebiotics is studied to establish so-called "proof of concept". Data from phase 1 are used to look at connections between the composition of intestinal flora, nutritional status and bowel function. The intervention involves the use of a prebiotic product (Stimulance, Nutricia), which is added to childs regular food. In phase 2, patients are randomized into two groups. One group will continue with the product for 6 months, while the other group does not receive prebiotics.

Conditions

Intestinal Pseudo-Obstruction; Short Bowel Syndrome; Malabsorption Syndrome Autoimmune Enteropathy; Bacterial Overgrowth

Outcome Measures

Primary Outcomes (3)

• Changes in Quality of life scores before and after treatment with prebiotics

  Changes in Pediatric quality of life inventory scores on an analog scale from 0-100 where higher scores means better outcome

  6 months

• Changes in gastro intestinal symptoms scores before and after treatment with prebiotics

  Pediatric quality of life inventory Gastro intestinal symptom scale scores on an analog scale from 0-100 where higher scores means better outcome

  6 months

• Changes in familt impact scores before and after treatment with prebiotics

  Pediatric quality of life inventory Family Impact Module scores on an analog scale from 0-100 where higher scores means better outcome

  6 months

Secondary Outcomes (1)

• Changes in Microbiota

  6 months

Study Arms (3)

Stimulance

EXPERIMENTAL

4 weeks intervention with Stimulance for all participants

Dietary Supplement: Stimulance

Stimulance 6 months

EXPERIMENTAL

6 months intervention

Dietary Supplement: Stimulance

No intervention

NO INTERVENTION

6 months control group

Interventions

Stimulance DIETARY_SUPPLEMENT

Intervention with Prebiotic supplement

Stimulance; Stimulance 6 months

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with congenital malformations or diseases requiring intestinal surgery leading to short bowel syndrome or
• Diagnosed with conditions and diseases leading to intestinal failure e.g pseudo obstruction.
• And Treated with parenteral nutrition for minimum 60 days within a 74 day period.

You may not qualify if:

• Children in need of temporary advanced nutrition intervention due to illness, e.g. infections.
• Children with temporary malfunctioning gut due to advanced medical treatment, for example cancer treatment or transplantation

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hopspital

Oslo, 0424, Norway

Location

Related Publications (1)

• Thomassen RA, Kvammen JA, Bentsen BS, Bratlie M, Bohn SK, Farstad H, Kahrs C, Ngo L, Nybo C, Saeland C, Tjora E, Tronstad RR, Stordal K, Brun AC, Henriksen C. Effect of prebiotics on gastrointestinal symptoms and quality of life in children with intestinal failure: A pilot study. J Pediatr Gastroenterol Nutr. 2025 Oct;81(4):975-985. doi: 10.1002/jpn3.70186. Epub 2025 Aug 6.

  PMID: 40770855 DERIVED

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction; Short Bowel Syndrome; Autoimmune enteropathy

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Malabsorption Syndromes; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rut Anne Thomassen

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Anne Charlotte Brun, MD PhD

  Oslo University Hospital

  STUDY DIRECTOR

• Christine Henriksen, PhD

  University of Oslo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian

Model Details: Intervention with prebiotics to all participants for 4 weeks. Then randomisation to continue with prebiotics for 6 months or no intervention.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 28, 2021
• Study Start: September 2, 2021
• Primary Completion: December 2, 2023
• Study Completion: December 15, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)