QClinical
Rotterdam, 3051 GV, Netherlands
NCT Number: NCT05902806
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Rotterdam, 3051 GV, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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.
Time frame: 7 days in the 1-week baseline period
self-reported GI symptoms with a GI symptom questionnaire
Time frame: 7 days in the second week of the 2-week intervention period
self-reported GI symptoms with a GI symptom questionnaire
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
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
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).
Self reported volume of feed administered
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 compliance
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).
Self reported complementary feeding
Time frame: Day 7 end of baseline period regarding the current tube feed
Self reported product acceptability
Time frame: Day 21 (end of intervention period regarding the upgraded tube feed)
Self reported product acceptability
Time frame: Baseline Day 1
Body Height (cm)
Time frame: Baseline Day 1
Body weight (kg)
Time frame: Baseline Day 7
Body weight (kg)
Time frame: Intervention Day 7
Body weight (kg)
Time frame: Intervention Day 14
Body weight (kg)
Time frame: Intervention Day 21
Body weight (kg)
Time frame: Baseline Day 1
Body mass index (kg/m^2)
Time frame: Baseline Day 7
Body mass index (kg/m^2)
Time frame: Intervention Day 7
Body mass index (kg/m^2)
Time frame: Intervention Day 14
Body mass index (kg/m^2)
Time frame: Intervention Day 21
Body mass index (kg/m^2)
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
Self reported use of predefined relevant medication with questionnaire (e.g. GI related medication like use of laxatives, antidiarrheals)
Nutricia Research
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07036081
Enteral Feeds, Enteral Nutrition (Food for Special Medical Purposes)
Nottingham, Nottinghamshire, United Kingdom
View Trial Details