Intestinal Pseudo-ObstructionNCT04981262
Improved Quality of Life in Children With Intestinal Failure
A study testing Stimulance in people with Intestinal Pseudo-Obstruction and Short Bowel Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Intestinal Pseudo-Obstruction, Short Bowel Syndrome, Malabsorption Syndrome Autoimmune Enteropathy
- What is being tested?
- Stimulance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNorway
- Study dates
- 2 Sep 2021to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Quality of Life in Children With Intestinal Failure - a Randomised Intervention Trial
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 The investigators own (unpublished) data show that children with intestinal failure have a lower quality of life than healthy people.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.
Read the 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.
- Conditions
- Intestinal Pseudo-Obstruction, Short Bowel Syndrome, Malabsorption Syndrome Autoimmune Enteropathy, Bacterial Overgrowth
- Being tested
- Stimulance
- Medical subject headings
- Intestinal Pseudo-Obstruction, Short Bowel Syndrome, Autoimmune enteropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimulanceDietary supplement
Intervention with Prebiotic supplement
| Study group | Role | What they receive |
|---|---|---|
| Stimulance | Experimental | 4 weeks intervention with Stimulance for all participants Receives: Dietary Supplement: Stimulance |
| Stimulance 6 months | Experimental | 6 months intervention Receives: Dietary Supplement: Stimulance |
| No intervention | No intervention | 6 months control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (1)
Changes in Microbiota
Measured by Short Chain Fatty Acids and microbiota composition
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start2 Sep 2021
- Primary completion2 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intestinal Pseudo-ObstructionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Rut Anne Thomassen, Oslo University Hospital
- Investigators
- Rut Anne Thomassen, Principal investigator, Oslo University HospitalAnne Charlotte Brun, MD PhD, Study director, Oslo University HospitalChristine Henriksen, PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981262
- Sponsor's protocol ID
- 170851
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40770855Thomassen RA, Kvammen JA, Bentsen BS, Solheim A, Stordal K, Henriksen C, Brun AC. Impact of parenteral nutrition on quality of life, the family and gastrointestinal symptoms in children with intestinal failure. J Pediatr Gastroenterol Nutr. 2025 Jan;80(1):69-79. doi: 10.1002/jpn3.12411. Epub 2024 Nov 22.
PubMed 39575826
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Quality of Life in Children With Intestinal Failure - a Randomised Intervention Trial
- ClinicalTrials.gov ID
- NCT04981262
- Acronym / sponsor ID
- 170851
- Conditions
- Intestinal Pseudo-Obstruction, Short Bowel Syndrome, Malabsorption Syndrome Autoimmune Enteropathy, Bacterial Overgrowth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 2 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Intervention with prebiotics to all participants for 4 weeks. Then randomisation to continue with prebiotics for 6 months or no intervention.
| Arm | Type | Receives |
|---|---|---|
| Stimulance | Experimental | Dietary Supplement: Stimulance4 weeks intervention with Stimulance for all participants |
| Stimulance 6 months | Experimental | Dietary Supplement: Stimulance6 months intervention |
| No intervention | No intervention | –6 months control group |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimulanceIntervention with Prebiotic supplement | Dietary supplement | Stimulance, Stimulance 6 months |
Primary outcome
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
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
Changes in familt impact scores before and after treatment with prebiotics
Time frame: 6 months
Pediatric quality of life inventory Family Impact Module scores on an analog scale from 0-100 where higher scores means better outcome
1 secondary outcome
Changes in Microbiota
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 40770855Thomassen 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.
- Derived from this study: PubMed 39575826Thomassen RA, Kvammen JA, Bentsen BS, Solheim A, Stordal K, Henriksen C, Brun AC. Impact of parenteral nutrition on quality of life, the family and gastrointestinal symptoms in children with intestinal failure. J Pediatr Gastroenterol Nutr. 2025 Jan;80(1):69-79. doi: 10.1002/jpn3.12411. Epub 2024 Nov 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rut Anne Thomassen principal investigator
Oslo University Hospital
Anne Charlotte Brun, MD PhD study director
Oslo University Hospital
Christine Henriksen, PhD study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulance in people with Intestinal Pseudo-Obstruction and Short Bowel Syndrome, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of life scores before and after treatment with prebiotics (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981262, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.