Microbiome and metabonomics changes with intestinal growth factors
Research type
Research Study
Full title
Microbiome and metabonomics in patients with intestinal failure receiving peptide growth hormones
IRAS ID
270309
Contact name
Simon Gabe
Contact email
Sponsor organisation
Reseach and Development Department, London North West University Healthcare NHS Trust
Clinicaltrials.gov Identifier
19/NI/0197, HSC REC A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Intestinal failure is defined the reduction of gut function below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth.
Intestinal failure is a rare condition, with prevalence of 25 cases per million population. The incidence and prevalence of patients with intestinal failure is increasing. Intestinal failure is caused by either short bowel or bowel dysfunction despite adequate length. Standard management of intestinal failure is home parenteral nutrition (HPN).
Intestinal growth and maintenance are mediated by a range of growth factors and cytokines. It is known that following development of short bowel syndrome there is an adaptive process associated with altered expression of these factors, which attempts to compensate for the loss of absorptive area, through structural and functional changes to the intestine. There is increasing evidence that intestinal growth factors have the potential to be used therapeutically to hasten and exceed the normal adaptive process. By maximising gut function, the amount of parenteral nutrition can be reduced. However, little is known about how these medications affect complex interactions between host metabolism and gut microbiome.
This study will recruit patients who are starting an intestinal growth factor medication (teduglutide, liraglutide or glepaglutide). Urine, blood and stool samples will be collected before and after the medication. Changes in metabolic profiles and gut microbiome will be studied. This will help understand how these medications work to increase gut adaptation and reduce parenteral nutrition.
REC name
HSC REC A
REC reference
19/NI/0197
Date of REC Opinion
9 Oct 2019
REC opinion
Favourable Opinion