Enteral Tube NutritionNCT05902806
Evaluation of the Gastro-intestinal Tolerance of an Upgraded Composition of an Enteral Tube Feed for Adults
A study testing Upgraded tube feed in people with Enteral Tube Nutrition, run by Nutricia Research at 1 site in Netherlands.
Trial summary
This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Tube Nutrition
- What is being tested?
- Upgraded tube feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 May 2023to 5 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Using either an enteral tube feed with approximately 1.0 or 1.5 kcal/mL with or without fibers via a nasogastric tube (NGT), nasojejunal (NJT) or Percutaneous Endoscopic Gastrostomy (PEG) for at least 4 weeks prior to screening
- Actual and expected average daily intake of enteral nutrition at least 1000 kcal for at least 21 days after the start of baseline period
- Written informed consent from subject (or impartial witness after verbal consent of subject)
Who cannot join
- 1. Subjects receiving total parental feeding (TPN) 2. Gastro-intestinal surgery or any other surgery involving general anaesthesia within 2 weeks prior to screening 3. Subjects with major hepatic or renal dysfunction in the opinion of the Investigator 4. Subjects currently in the intensive care unit 5. Active/flare up condition of chronic illnesses in small or large intestines in the opinion of the Investigator (e.g., active inflammation/flare up of Crohn's disease or ulcerative colitis) within 2 weeks prior to screening, 6. Subjects experiencing cancer treatment-related diarrhea within 2 weeks prior to screening 7. Presence of colostomy or other faecal diversion 8. Known intolerance or allergy to ingredients of study product (e.g. galactosemia, allergy to soy) 9. Inability of the subject to answer the study diary or questionnaires due to e.g., being unconscious, cognitive impairment, or dementia, in the opinion of the Investigator 10. Known pregnancy or lactation 11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 12. Active participation in any other clinical study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study in the opinion of the Investigator
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Gastro-intestinal Tolerance, Nutritional Intake, and Acceptability of an Upgraded Composition of an Enteral Tube Feed for Adults in Need of Long Term Nutritional Support (Peacock Butterfly)
This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support.
Read the detailed description
Four current tube feed products are upgraded with the same product composition and will be investigated in this study. Subjects will be asked to continue with their current tube feeding for 7 days (baseline period) and asked to complete a daily gastro-intestinal tolerance questionnaire. On Day 8, the subjects will switch to one of four upgraded tube feeding products for 14 days (intervention period). The subjects are asked to complete the same gastro-intestinal tolerance questionnaire for again 7 days. On Day 21 (end of intervention), the subjects will return to their original tube feed product and the investigator will follow up on how they are feeling to evaluate tolerability and product acceptability.
- Conditions
- Enteral Tube Nutrition
- Being tested
- Upgraded tube feed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upgraded tube feedDietary supplement
Total duration of study: 4 weeks; 1 week on current tube feed followed by 2 weeks on upgraded tube feed comparable in energy density and fiber content as their current tube feed. The tube feeding regimen is similar to pre study feeding regimen. There will then be a one week follow up period.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of current tube feed to intervention feed with upgraded composition | Experimental | Subjects will use their own current practice tube feed for 1 week (baseline period) and will switch to the intervention tube feed with an upgraded composition with a comparable energy density and fiber content as their current tube for 2 weeks (intervention period). Since four different products will be evaluated (product A-D), there will be 4 study groups Receives: Dietary Supplement: Upgraded tube feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-intestinal tolerance
self-reported GI symptoms with a GI symptom questionnaire
Measured: 7 days in the 1-week baseline period
Gastro-intestinal tolerance
self-reported GI symptoms with a GI symptom questionnaire
Measured: 7 days in the second week of the 2-week intervention period
bowel movement pattern
Self reported bowel movement pattern with the 7-point Bristol Stool Form Scale (BSFS) ranging from "1" (indicating separate, hard lumps) to "7", which stands for entirely liquid, watery stool without any hard components
Measured: 7 days in the 1-week baseline period
bowel movement pattern
Self reported bowel movement pattern with the 7-point Bristol Stool Form Scale (BSFS) ranging from "1" (indicating separate, hard lumps) to "7", which stands for entirely liquid, watery stool without any hard components
Measured: 7 days in the second week of the 2-week intervention period
Secondary outcomes (16)
Volume of tube feed administration
Self reported volume of feed administered
Measured: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
Difference between prescribed volume of tube feed administration by Health Care Professional and actual daily self-reported administrated volume of tube feed
Product compliance
Measured: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
Use of complementary feeding with a questionnaire ((use of normal foods, oral nutritional supplements, parenteral feeding: Yes/No)
Self reported complementary feeding
Measured: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
Product acceptability with a questionnaire
Self reported product acceptability
Measured: Day 7 end of baseline period regarding the current tube feed
Product acceptability with a questionnaire
Self reported product acceptability
Measured: Day 21 (end of intervention period regarding the upgraded tube feed)
Anthropometrics
Body Height (cm)
Measured: Baseline Day 1
Anthropometrics
Body weight (kg)
Measured: Baseline Day 1
Anthropometrics
Body weight (kg)
Measured: Baseline Day 7
Anthropometrics
Body weight (kg)
Measured: Intervention Day 7
Anthropometrics
Body weight (kg)
Measured: Intervention Day 14
Anthropometrics
Body weight (kg)
Measured: Intervention Day 21
Anthropometrics
Body mass index (kg/m^2)
Measured: Baseline Day 1
Anthropometrics
Body mass index (kg/m^2)
Measured: Baseline Day 7
Anthropometrics
Body mass index (kg/m^2)
Measured: Intervention Day 7
Anthropometrics
Body mass index (kg/m^2)
Measured: Intervention Day 14
Anthropometrics
Body mass index (kg/m^2)
Measured: Intervention Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start23 May 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral Tube NutritionStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label, multi-centre, multi-country, exploratory study
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902806
- Sponsor's protocol ID
- SBB22R&56358
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Berg CA, van Eijnatten EJM, Top P, Zoubek-Wojcik A, Wojcik P, Csomor J, Sels M, Amodio S, Veldhorst M, Hofman Z. Gastrointestinal tolerance and compliance during a 2-week intervention of reformulated tube feeds with a plant-dominant protein blend in community-based adult patients on long-term nutritional support. Eur J Clin Nutr. 2026 Sep 5. doi: 10.1038/s41430-026-01814-2. Online ahead of print.
PubMed 42701131
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Gastro-intestinal Tolerance, Nutritional Intake, and Acceptability of an Upgraded Composition of an Enteral Tube Feed for Adults in Need of Long Term Nutritional Support (Peacock Butterfly)
- ClinicalTrials.gov ID
- NCT05902806
- Acronym / sponsor ID
- SBB22R&56358
- Conditions
- Enteral Tube Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 15 Jun 2023 (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.
This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support.
Detailed description
Four current tube feed products are upgraded with the same product composition and will be investigated in this study. Subjects will be asked to continue with their current tube feeding for 7 days (baseline period) and asked to complete a daily gastro-intestinal tolerance questionnaire. On Day 8, the subjects will switch to one of four upgraded tube feeding products for 14 days (intervention period). The subjects are asked to complete the same gastro-intestinal tolerance questionnaire for again 7 days. On Day 21 (end of intervention), the subjects will return to their original tube feed product and the investigator will follow up on how they are feeling to evaluate tolerability and product acceptability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label, multi-centre, multi-country, exploratory study
| Arm | Type | Receives |
|---|---|---|
| Comparison of current tube feed to intervention feed with upgraded composition | Experimental | Dietary Supplement: Upgraded tube feedSubjects will use their own current practice tube feed for 1 week (baseline period) and will switch to the intervention tube feed with an upgraded composition with a comparable energy density and fiber content as their current tube for 2 weeks (intervention period). Since four different products will be evaluated (product A-D), there will be 4 study groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Using either an enteral tube feed with approximately 1.0 or 1.5 kcal/mL with or without fibers via a nasogastric tube (NGT), nasojejunal (NJT) or Percutaneous Endoscopic Gastrostomy (PEG) for at least 4 weeks prior to screening
- Actual and expected average daily intake of enteral nutrition at least 1000 kcal for at least 21 days after the start of baseline period
- Written informed consent from subject (or impartial witness after verbal consent of subject)
Key exclusion criteria (2 listed)
- 1. Subjects receiving total parental feeding (TPN) 2. Gastro-intestinal surgery or any other surgery involving general anaesthesia within 2 weeks prior to screening 3. Subjects with major hepatic or renal dysfunction in the opinion of the Investigator 4. Subjects currently in the intensive care unit 5. Active/flare up condition of chronic illnesses in small or large intestines in the opinion of the Investigator (e.g., active inflammation/flare up of Crohn's disease or ulcerative colitis) within 2 weeks prior to screening, 6. Subjects experiencing cancer treatment-related diarrhea within 2 weeks prior to screening 7. Presence of colostomy or other faecal diversion 8. Known intolerance or allergy to ingredients of study product (e.g. galactosemia, allergy to soy) 9. Inability of the subject to answer the study diary or questionnaires due to e.g., being unconscious, cognitive impairment, or dementia, in the opinion of the Investigator 10. Known pregnancy or lactation 11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 12. Active participation in any other clinical study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study in the opinion of the Investigator
- -
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 |
|---|---|---|
| Upgraded tube feedTotal duration of study: 4 weeks; 1 week on current tube feed followed by 2 weeks on upgraded tube feed comparable in energy density and fiber content as their current tube feed. The tube feeding regimen is similar to pre study feeding regimen. There will then be a one week follow up period. | Dietary supplement | Comparison of current tube feed to intervention feed with upgraded composition |
Primary outcome
Gastro-intestinal tolerance
Time frame: 7 days in the 1-week baseline period
self-reported GI symptoms with a GI symptom questionnaire
Gastro-intestinal tolerance
Time frame: 7 days in the second week of the 2-week intervention period
self-reported GI symptoms with a GI symptom questionnaire
bowel movement pattern
Time frame: 7 days in the 1-week baseline period
Self reported bowel movement pattern with the 7-point Bristol Stool Form Scale (BSFS) ranging from "1" (indicating separate, hard lumps) to "7", which stands for entirely liquid, watery stool without any hard components
bowel movement pattern
Time frame: 7 days in the second week of the 2-week intervention period
Self reported bowel movement pattern with the 7-point Bristol Stool Form Scale (BSFS) ranging from "1" (indicating separate, hard lumps) to "7", which stands for entirely liquid, watery stool without any hard components
16 secondary outcomes
Volume of tube feed administration
Time frame: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
Difference between prescribed volume of tube feed administration by Health Care Professional and actual daily self-reported administrated volume of tube feed
Time frame: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
Use of complementary feeding with a questionnaire ((use of normal foods, oral nutritional supplements, parenteral feeding: Yes/No)
Time frame: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
Product acceptability with a questionnaire
Time frame: Day 7 end of baseline period regarding the current tube feed
Product acceptability with a questionnaire
Time frame: Day 21 (end of intervention period regarding the upgraded tube feed)
Anthropometrics
Time frame: Baseline Day 1
Anthropometrics
Time frame: Baseline Day 1
Anthropometrics
Time frame: Baseline Day 7
Anthropometrics
Time frame: Intervention Day 7
Anthropometrics
Time frame: Intervention Day 14
Anthropometrics
Time frame: Intervention Day 21
Anthropometrics
Time frame: Baseline Day 1
Anthropometrics
Time frame: Baseline Day 7
Anthropometrics
Time frame: Intervention Day 7
Anthropometrics
Time frame: Intervention Day 14
Anthropometrics
Time frame: Intervention Day 21
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 12 Mar 2024.
- Derived from this study: PubMed 42701131van den Berg CA, van Eijnatten EJM, Top P, Zoubek-Wojcik A, Wojcik P, Csomor J, Sels M, Amodio S, Veldhorst M, Hofman Z. Gastrointestinal tolerance and compliance during a 2-week intervention of reformulated tube feeds with a plant-dominant protein blend in community-based adult patients on long-term nutritional support. Eur J Clin Nutr. 2026 Sep 5. doi: 10.1038/s41430-026-01814-2. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Enteral Tube Nutrition
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Not yet recruiting
TubeClear System Evaluation in Pediatric Patients
Clogged Enteral Access Devices, Occluded Enteral Access Devices
Not yet recruiting
We Need to FEED: Facilitating Enteral Education for Discharge
Enteral Nutrition Feeding
Recruiting
Plant-Protein Dominant Tube Feed Study
Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds
Recruiting
Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS
Amyotrophic Lateral Sclerosis, Gastrointestinal Intolerance
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upgraded tube feed in people with Enteral Tube Nutrition, run by Nutricia Research at 1 site in Netherlands.
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 4 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 12 Mar 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 Netherlands. 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?
Gastro-intestinal tolerance (time frame: 7 days in the 1-week baseline period). The study lists 4 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 NCT05902806, which also lists 1 linked publication.
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 12 Mar 2024.