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Improved Quality of Life in Children With Intestinal Failure

Improved Quality of Life in Children With Intestinal Failure - a Randomised Intervention Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04981262
Enrollment
56
Registered
2021-07-28
Start date
2021-09-02
Completion date
2023-12-15
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 The investigators own (unpublished) data show that children with intestinal failure have a lower quality of life than healthy people.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.

Detailed description

Quality of life, gastrointestinal symptoms and family impact are measured using validated forms for four weeks before intervention phase 1, at start-up and after phase 1, as well as after phase 2. Stool samples are collected at the same time points. Weight, height is measured and blood tests are collected at the start and end of phases 1 and 2. Data on diet and nutritional treatment are collected at the start and end of the two phases. The stool samples are analyzed for short fatty acids (marker for good intestinal health), the composition of the intestinal flora and inflammation markers. Blood samples are analyzed for infection markers, intestinal health markers and nutritional markers. Nutritional data are analyzed for nutrient content and the dependence on nutritional support is calculated. The investigators expect that the study will lead to an improved quality of life for the patient group through increased tolerance to food in the intestine, reduced antibiotic use and reduction of gastrointestinal symptoms. The project is patient-oriented.

Interventions

DIETARY_SUPPLEMENTStimulance

Intervention with Prebiotic supplement

Sponsors

University of Oslo
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

are: * 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Quality of life scores before and after treatment with prebiotics6 monthsChanges in Pediatric quality of life inventory scores on an analog scale from 0-100 where higher scores means better outcome
Changes in gastro intestinal symptoms scores before and after treatment with prebiotics6 monthsPediatric quality of life inventory Gastro intestinal symptom scale scores on an analog scale from 0-100 where higher scores means better outcome
Changes in familt impact scores before and after treatment with prebiotics6 monthsPediatric quality of life inventory Family Impact Module scores on an analog scale from 0-100 where higher scores means better outcome

Secondary

MeasureTime frameDescription
Changes in Microbiota6 monthsMeasured by Short Chain Fatty Acids and microbiota composition

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026