Digestive Health Clinical Trials

Scientific Background

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 a) subjective assessments such as well-being, quality of life, gut health and eating habits using validated questionnaires and b) 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 varied food investigational products (IP), ranging from probiotics, peptides, fruit extracts to marine extracts and have a large database of healthy, IBS and other GI patient populations to support volunteer recruitment. 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 and statistically powering studies to ensure that study 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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