Monitor the Impact of ISOJMIX on gastrointestinal tolerance
Research type
Research Study
Full title
Monitor the effect of Partial Real Food Blended Enteral Nutrition (Isosource Junior Mix – Nestle) on Gastrointestinal Tolerance and Microbiomes in Paediatric Inpatients
IRAS ID
279901
Contact name
GRAEME O'CONNOR
Contact email
Sponsor organisation
Great Ormond Street Hospital
Clinicaltrials.gov Identifier
researchregistry6860, Research Registry
Duration of Study in the UK
1 years, 9 months, 23 days
Research summary
Enteral nutrition is the preferred route for the nutritional support for patients who are unable to meet their nutritional requirements orally. [1-4]. Clinical manifestations of feeding intolerance, such as abdominal distension, bloating, and nausea, are some of the complications that can occur in patients.[5]
The frequency of diarrhoea in enteral nutrition in critically ill patients ranges from 29% to 72%. [6] Yagmurdur et al. identified diarrhoea as the most frequent complication, which occurred in half of the patients.[7] Diarrhoea contributes to malnutrition through reduction in nutritional intake, decrease in absorption of nutrients, and increase in catabolism of nutrient reserves. [8]
Additionally, antibiotic treatment is strongly associated with diarrhoea in patients receiving enteral nutrition and is associated with alterations of gut microbiota (dybiosis), which leads to increased risk of pathogen overgrowth and altered metabolism of macronutrients which induces osmotic diarrhoea and malabsorption of essential nutrients. [9-13]
There is evidence for the beneficial effects of fibre enriched enteral formulas, which can stimulate the growth of beneficial normal flora bacteria, thereby inhibiting harmful bacteria. [14-15]. Fibre that include fructo-oligosaccharides and inulin were shown to increase the concentrations of bifidobacteria. Lactobacillus and bifidobacteria are referred to as probiotics and improve gut barrier function, host immunity, and reduce overgrowth of pathogenic bacteria, such as Clostridia [17]
The use of fibre in all hemodynamically stable, critically ill patients is safe and may be considered to be beneficial for reducing gastrointestinal symptoms, mainly diarrhoea. Supplementation of enteral nutrition with fructo-oligosaccharides may prevent such adverse changes [18]. Blended diet refers to the use of blended family foods administered into an enteral feeding tube. Interest is growing in the use of blended diet for management of feeding difficulties, reflux, and improved bowel function in the paediatric population. [19][20]REC name
London - Hampstead Research Ethics Committee
REC reference
21/PR/0809
Date of REC Opinion
17 Jun 2021
REC opinion
Favourable Opinion