CPV Vegetarian tube feed Study

• Research type

  Research Study

• Full title

  Acceptability (including gastrointestinal tolerance, compliance of a paediatric vegetarian tube feed containing food derived ingredients

• IRAS ID

  362942

• Contact name

  Graeme O'Connor

• Sponsor organisation

  Nestle Health Science

• Duration of Study in the UK

  0 years, 10 months, 30 days

• Research summary

  Gastrointestinal tolerance describes the ability of the digestive system, including the stomach, small intestine and large intestine to function smoothly, accept and process food comfortably and absorb nutrients from food or formula without causing discomfort or adverse reactions.
  There are several factors that can affect the tolerance of the digestive system. These include structural abnormalities or malabsorption issues, caused by any of the following conditions: short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.
  Patients with gastrointestinal tolerance problems require nutritional support strategies such as tube feeds. This is because they can significantly impact an individual’s ability to consume adequate nutrition.
  A tube feed is a medical method of delivering liquid nutrition directly into the stomach or small intestine through a tube when a person cannot eat enough food orally to meet their nutritional needs. Monitoring the patient closely to ensure proper tolerance and absorption of feed is very crucial to prevent complications.
  This study is a single arm, prospective, single-centre study that will include twenty five (25) paediatric participants who well established and stable on Compleat paediatric or any other paediatric tube feed.
  Participants will receive a 28 day supply of the vegetarian version of Compleat® paediatric PB tube feed, and will be asked to complete a daily diary and short questionnaire to evaluate the gastrointestinal tolerance and compliance.
  The recruitment period will be 12 months.
  

• REC name

  Yorkshire & The Humber - South Yorkshire Research Ethics Committee

• REC reference

  25/YH/0221

• Date of REC Opinion

  4 Dec 2025

• REC opinion

  Further Information Favourable Opinion