Digestive Health Clinical Trials
- Scientific Background
- What Atlantia Offer
- Measurements & Indications
Digestive, Gastrointestinal (GI) or ‘gut health’ covers multiple positive aspects of the GI tract. Beyond effective digestion and absorption of food, it refers to the absence of GI illness (such as Inflammatory Bowel Disease or Irritable Bowel Syndrome (IBS)), normal and stable intestinal microbiota, effective immune status and a state of mental wellbeing. Two functional entities, the GI microbiome and the GI barrier, are key to achieving and maintaining gut health. Dysbiosis (microbial imbalance) and increased intestinal permeability (also referred to as leaky gut) have been linked to a myriad of chronic health problems such as diabetes, obesity, autoimmune diseases, arthritis and IBS. Thus, ways of improving and maintaining gut health are of major interest
To assess gut health, diagnostic methods must cover both:
- Subjective assessments such as well-being, quality of life, gut health and eating habits using validated questionnaires and
- Objective parameters which assess the functionality, integrity, immunity and microbiota of the GI tract.
What Atlantia offer
Atlantia Food Clinical Trials has extensive experience in conducting human dietary intervention studies in the area of digestive health in various target populations including infants and the elderly, and patient groups (e.g. IBS).
We have conducted trials on a variety of investigational food products (IP), ranging from probiotics, prebiotics, fibers and a range of other substrates, e.g. bacteriophage and sweetners, etc.
We have a large database of healthy subjects striated across gender and age, and also a considerable patient database (IBS and other GI indictions).
Our expert research team will work with sponsor(s) to design and conduct a study most suitable for their IP, agreeing and applying the most suitable diagnostics. We can statistically power your study to ensure that your objectives are achieved and reported in accordance with EFSA and FDA guidelines.
Measurements & Indications
|Gastrointestinal Health Assessment (SUBJECTIVE) |
|Dietary ||FFQ, 24 h recall, nutretics, mobile phone app |
|Well-being ||Health Status Questionnaire (HSQ), Short Form Health Survey (SF) |
|GI health ||Bristol Stool Scale, Gastrointestinal Symptom Rating Scale (GSRS), IBS Severity Scoring System (IBS-SSS) |
|Gastrointestinal Health Assessment (OBJECTIVE) |
|Gut Functionality ||Function: oesophageal pH metry, faecal weight and consistency; Transit time: radiopaque pellets; Permeability: lactulose-mannitol tracer test; Motility: gastric scintigraphy, |
|Gut Integrity ||Epithelial integrity: histology, mucus secretion; Biomarkers: E-cadherin, growth factors, tight junction molecules, lipopolysaccharide (LPS) in blood, a-antitrypsin in faeces; Antimicrobial peptides: a- and b-defensins, calprotectin |
|Immunity / Inflammation ||Immunoglobulins: IgA, IgE; Proteases: tryptase, chymase; Inflammatory cell signalling pathways: MAPK, NFkB, Cox 1 & 2; Inflammation: cytokines (Interleukins (IL) & TNFa), hsCRP, salivary cortisol, stool calprotectin |
|Microbiota ||Shotgun sequencing, functional genomics, metabolomics, transcriptomics |
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Check our Resources on Digestive Health
Digestive Health Publications