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Completed

NCT Number: NCT05902806

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QClinical

Rotterdam, 3051 GV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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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Treatment and study plan

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.

Primary outcomes

  1. Gastro-intestinal tolerance

    Time frame: 7 days in the 1-week baseline period

    self-reported GI symptoms with a GI symptom questionnaire

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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).

    Self reported volume of feed administered

  2. 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).

    Product compliance

  3. 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).

    Self reported complementary feeding

  4. Product acceptability with a questionnaire

    Time frame: Day 7 end of baseline period regarding the current tube feed

    Self reported product acceptability

  5. Product acceptability with a questionnaire

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

    Self reported product acceptability

  6. Anthropometrics

    Time frame: Baseline Day 1

    Body Height (cm)

  7. Anthropometrics

    Time frame: Baseline Day 1

    Body weight (kg)

  8. Anthropometrics

    Time frame: Baseline Day 7

    Body weight (kg)

  9. Anthropometrics

    Time frame: Intervention Day 7

    Body weight (kg)

  10. Anthropometrics

    Time frame: Intervention Day 14

    Body weight (kg)

  11. Anthropometrics

    Time frame: Intervention Day 21

    Body weight (kg)

  12. Anthropometrics

    Time frame: Baseline Day 1

    Body mass index (kg/m^2)

  13. Anthropometrics

    Time frame: Baseline Day 7

    Body mass index (kg/m^2)

  14. Anthropometrics

    Time frame: Intervention Day 7

    Body mass index (kg/m^2)

  15. Anthropometrics

    Time frame: Intervention Day 14

    Body mass index (kg/m^2)

  16. Anthropometrics

    Time frame: Intervention Day 21

    Body mass index (kg/m^2)

Other outcomes

  1. Medication

    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)

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Mar 12, 2024

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.

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