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Improved Quality of Life in Children With Intestinal Failure

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ClinicalTrials.gov Identifier: NCT04981262
Recruitment Status : Not yet recruiting
First Posted : July 28, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Rut Anne Thomassen, Oslo University Hospital

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 The investigators own (unpublished) data show that children with intestinal failure have a lower quality of life than healthy people.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

Condition or disease Intervention/treatment Phase
Intestinal Pseudo-Obstruction Short Bowel Syndrome Malabsorption Syndrome Autoimmune Enteropathy Bacterial Overgrowth Dietary Supplement: Stimulance Not Applicable

Detailed Description:

Quality of life and gastrointestinal symptoms 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention with prebiotics to all participants for 4 weeks. Then randomisation to continue with prebiotics for 6 months or no intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improved Quality of Life in Children With Intestinal Failure - a Randomised Intervention Trial
Estimated Study Start Date : September 2, 2021
Estimated Primary Completion Date : June 2, 2022
Estimated Study Completion Date : June 2, 2022


Arm Intervention/treatment
Experimental: Stimulance
4 weeks intervention with Stimulance for all participants
Dietary Supplement: Stimulance
Intervention with Prebiotic supplement

Experimental: Stimulance 6 months
6 months intervention
Dietary Supplement: Stimulance
Intervention with Prebiotic supplement

No Intervention: No intervention
6 months control group



Primary Outcome Measures :
  1. Changes in Quality of life scores before and after treatment with prebiotics [ Time Frame: 6 months ]
    Changes in Pediatric quality of life inventory scores on an analog scale from 0-100 where higher scores means better outcome

  2. Changes in gastro intestinal symptoms scores before and after treatment with prebiotics [ Time Frame: 6 months ]
    Pediatric quality of life inventory Gastro intestinal symptom scale scores on an analog scale from 0-100 where higher scores means better outcome


Secondary Outcome Measures :
  1. Changes in Microbiota [ Time Frame: 6 months ]
    Measured by Short Chain Fatty Acids and microbiota composition



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 >3 months

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981262


Contacts
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Contact: Rut Anne Thomassen + 4722118765 uxruom@ous-hf.no
Contact: Anne Charlotte Brun, MD PhD +4722118765 bruan@ous-hf.no

Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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Principal Investigator: Rut Anne Thomassen Oslo University Hospital
Study Director: Anne Charlotte Brun, MD PhD Oslo University Hospital
Study Chair: Christine Henriksen, PhD University of Oslo
  Study Documents (Full-Text)

Documents provided by Rut Anne Thomassen, Oslo University Hospital:
Study Protocol  [PDF] June 21, 2021

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Responsible Party: Rut Anne Thomassen, Clinical Dietitian, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04981262    
Other Study ID Numbers: 170851
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Pseudo-Obstruction
Syndrome
Disease
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Metabolic Diseases
Ileus
Intestinal Obstruction