The study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis), in the management of gastrointestinal distress in the general population and in subjects with IBS in the predominant form of IBS-C, with an impact on quality of life.
The primary outcome is the overall improvement of perceived gastrointestinal symptoms in subjects with IBS in the predominant form of IBS-C; than the secondary outcomes are the 1) assessment of the impact of constipation on perceived quality of life in the last 4 weeks, 2) effectiveness in improving stool consistency, 3) effectiveness of the frequency of bowel movements, 4) efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS, 5) effectiveness of the decrease in frequency in the use of salvage treatments 6) efficacy against abdominal pain to be evaluated separately from intestinal discomfort 7) evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin and 8) probiotic colonization rate, improving the quality of life of the subjects affected by IBS-C.
aged between 18 and 70 years
able to understand and sign informed consent
HIV negative test
negative pregnancy test
pregnancy
lactation
HIV positive
do not meet inclusion criteria.
Parallel
food supplement based on a mixture of green tea extract and a pool of probiotics.
Dietary supplementtwo capsules of food supplement (verum) or placebo, daily for 56 consecutive days. The daily consumption of the food supplement provides: green tea extract (Camellia sinensis (L.) Kuntze - folium) 300 mg, as a green capsule, and a pool of probiotics (Lactobacillus rhamnosus LRH020 2x10\^9 UFC, Bifidobacterium lactis BL050 2x10\^9 UFC, Lactobacillus plantarum PBS067 2x10\^9 UFC), as a white capsule.
Placebo
Dietary supplement1 capsule/day of maltodextrin (500 mg) with a green shell, and 1 capsule/day of maltodextrin (500 mg) with a white shell for 56 days. The two colours are applied to maintain the binding.
Efficacy of the food supplement in the overall improvement of perceived gastrointestinal symptoms.
Validated questionnaire for self-assessment of the severity of global gastrointestinal symptomatology characterizing IBS, IBS Severity Scoring System (IBS-SSS). The questionnaire consists of 5 items referring to: abdominal pain, bowel dysfunction and general well-being. It is commonly used as an outcome measure in clinical efficacy trials, due to its high sensitivity following treatment. The total score obtained allows to determine the severity of global gastrointestinal symptoms, whether IBS-related symptoms are mild, moderate or severe and whether, following treatment, there is an improvement in global symptoms in the treated group compared to the placebo group.
Assessment of the impact of constipation on perceived quality of life in the last 4 weeks
Quality of Life Questionnaire (Short Form Health Survey-12 -SF-12) was developed in a multiyear study of patients with chronic conditions. It is a validated questionnaire widely used in clinical practice for self-assessment of quality of life against a generic disorder. The SF-12 questionnaire allows you to describe the health of a subject through two synthetic indices calculated on 12 questions. The index called Physical Component Summary (PCS), concerns the physical state, while the Mental Component Summary (MCS) index measures the mental state.
The effectiveness in improving stool consistency.
Bristol Stool Form Scale (BSFS), a validated instrument that assesses stool consistency on a spectrum of seven types. Type 1 and 2 stools denote hard or lumpy stools, while type 6 and 7 stools are indicative of loose or watery stools. The stools that characterize subjects with intestinal hyperactivity are type 5, 6, 7. Stool consistency will be reported by the subject at visits and reported, during the study period, on the Bowel Function Diary.
The effectiveness of the frequency of bowel movements.
Number of bowel movements/week (BM/WK) will be reported by the subject at the visits (average BM/week over the previous 4 weeks) and reported, during the study period, on the bowel function diary.
The efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS.
The assessment of the frequency and intensity characteristics of the subject with constipated IBS form (feeling of bloating, abdominal distension, feeling of fullness, abdominal pain, flatulence) will be determined through the compilation of a 5-point Likert scale (0 no discomfort - 5 maximum discomfort), present within the bowel function diary. Daily registration is useful to avoid the "recall" bias that could occur when filling out questionnaires at pre-arranged visits.
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