Clinical trial NCT05902806: Evaluation of the Gastro-intestinal Tolerance of an Upgraded Composition of an Enteral Tube Feed for Adults
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Tube Nutrition
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, open-label, multi-centre, multi-country, exploratory study
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. 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
3. Actual and expected average daily intake of enteral nutrition at least 1000 kcal for at least 21 days after the start of baseline period
4. Written informed consent from subject (or impartial witness after verbal consent of subject)

Exclusion Criteria:

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

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Primary outcomes:
measure: Gastro-intestinal tolerance
timeFrame: 7 days in the 1-week baseline period
measure: Gastro-intestinal tolerance
timeFrame: 7 days in the second week of the 2-week intervention period
measure: bowel movement pattern
timeFrame: 7 days in the 1-week baseline period
measure: bowel movement pattern
timeFrame: 7 days in the second week of the 2-week intervention period
Secondary outcomes:
measure: Volume of tube feed administration
timeFrame: 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).
measure: Difference between prescribed volume of tube feed administration by Health Care Professional and actual daily self-reported administrated volume of tube feed
timeFrame: 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).
measure: Use of complementary feeding with a questionnaire ((use of normal foods, oral nutritional supplements, parenteral feeding: Yes/No)
timeFrame: 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).
measure: Product acceptability with a questionnaire
timeFrame: Day 7 end of baseline period regarding the current tube feed
measure: Product acceptability with a questionnaire
timeFrame: Day 21 (end of intervention period regarding the upgraded tube feed)
measure: Anthropometrics
timeFrame: Baseline Day 1
measure: Anthropometrics
timeFrame: Baseline Day 1
measure: Anthropometrics
timeFrame: Baseline Day 7
measure: Anthropometrics
timeFrame: Intervention Day 7
measure: Anthropometrics
timeFrame: Intervention Day 14
measure: Anthropometrics
timeFrame: Intervention Day 21
measure: Anthropometrics
timeFrame: Baseline Day 1
measure: Anthropometrics
timeFrame: Baseline Day 7
measure: Anthropometrics
timeFrame: Intervention Day 7
measure: Anthropometrics
timeFrame: Intervention Day 14
measure: Anthropometrics
timeFrame: Intervention Day 21
Other outcomes:
measure: Medication
timeFrame: 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
Locations:
city: Rotterdam
country: Netherlands
facility: QClinical
Study officials:
References: