Evaluation of the Gastro-intestinal Tolerance of an Upgraded Composition of an Enteral Tube Feed for Adults

NCT05902806 | Completed

• 1 other identifier: SBB22R&56358
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Tube Nutrition

Outcome Measures

Primary Outcomes (4)

• Gastro-intestinal tolerance

  self-reported GI symptoms with a GI symptom questionnaire

  7 days in the 1-week baseline period

• Gastro-intestinal tolerance

  self-reported GI symptoms with a GI symptom questionnaire

  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

  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

  7 days in the second week of the 2-week intervention period

Secondary Outcomes (16)

• Volume of tube feed administration

  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

  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)

  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

  Day 7 end of baseline period regarding the current tube feed

• Product acceptability with a questionnaire

  Day 21 (end of intervention period regarding the upgraded tube feed)

Other Outcomes (1)

• Medication

  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

Study Arms (1)

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

Dietary Supplement: Upgraded tube feed

Interventions

Upgraded tube feed DIETARY_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.

Comparison of current tube feed to intervention feed with upgraded composition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

QClinical

Rotterdam, 3051 GV, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, open-label, multi-centre, multi-country, exploratory study

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: June 15, 2023
• Study Start: May 23, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)