Digestive Health

Atlantia Food Clinical Trials has a particular strength in providing human dietary intervention studies and food human intervention studies in the area of digestive health, in accordance with EFSA guidelines on scientific requirements for assessing health claim validation related to gut and immune function (EFSA Journal 2011; 9(4):1984). We have extensive expertise in GI health trials and looking at digestive health in a variety of populations such as healthy, including infants and elderly, and in patient groups (e.g. Irritable Bowel Syndrome). We also have experience in trials with different test products, from probiotics to protein, and fruit extracts to marine extracts. We work with our clients to design a study most suitable for their products in accordance with EFSA guidelines, analysing peer-reviewed publications, agreeing the most suitable end-points and statistically powering studies to ensure that studies will meet requirements. We have a large database of healthy, IBS and GI patient populations to support volunteer recruitment.

With access to a number of gastroenterologists who are clinician-scientists, we have comprehensive experience in measuring all aspects of digestive health and discomfort, including –

  • Bowel function – transit time (e.g. X-ray with radio-opaque pellets), frequency of bowel movement, faecal bulk and stool consistency (e.g. Bristol stool scale)
  • Gastrointestinal pain or discomfort e.g. validated questionnaires on bloating, abdominal pain or cramping, borborygmi (rumbling), symptom diaries
  • Food diaries, including nutritional assessments and validated questionnaires
  • Integrity of the intestinal lining, gut permeability e.g. Lactulose-mannitol test, changes to inflammatory cytokines or to biomarkers of GI function in blood or urine
  • Digestion/absorption of nutrients – blood protein, free amino acid, nitrogen, urea levels, triglycerides, cholesterol, fatty acids; vitamin status; glucose/insulin levels; iron absorption
  • Irritable bowel syndrome (IBS), ulcerative colitis, Crohn’s disease
  • Defence against pathogens in the GI tract or other sites in the body e.g. reduction in number of infections or severity of infections (by clinical diagnosis, microbiological measures, or questionnaires)
  • Reduction in risk factors for GI infections (such as toxins or other virulence factors in faeces)
  • Monitor changes in gut microbiota induced by diet by various methods – PCR, microbiology or pyrosequencing
    Radiological imaging
  • Endoscopy, colonoscopy, gastroscopy, biopsy
  • Reduction of inflammation – measurement of inflammatory markers e.g. stimulated and non-stimulated IL6, IL8, IL10, IL12, IFNγ, IL1β, TNFα, CXCL10/IP10, SAA, salivary cortisol, hsCRP, stool calprotectin
  • Inflammatory cell signalling pathways e.g. MAPK, NFkB, Cox 1, Cox 2