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The Beneficial Effects on the Intestinal Function of a Food Supplement Based on an Extract of Green Tea and a Pool of Probiotics in Subjects With Irritable Bowel Syndrome With Predominance of Constipation

RecruitingNAAges 18 Years - 70 YearsAllAdamas Biotech S.r.l.
NCT07094035 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 de

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📋 Eligibility rules (as published)
Inclusion Criteria: * aged between 18 and 70 years * able to understand and sign informed consent * HIV negative test * negative pregnancy test * With IBS symptoms for at least 3 months (with onset at least 6 months earlier) * recurrent abdominal pain at least 1 day a week, associated with two or more of the following criteria: associated with the act of defecation, associated with a change in the frequency of bowel movements, associated with a change in the shape of the stool (Rome IV diagnostic criteria) * who have less than three BM/wk and at least one of the following conditions: * in more than 25%\* of defecatory acts * lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements * feeling of incomplete evacuation in more than 25% of defecations * feeling of anorectal obstruction/blockage in more than 25% of defecations * carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations * Able to understand and comply with the requirements of the protocol. Exclusion Criteria: * pregnancy * lactation * HIV positive * do not meet inclusion criteria.
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What it tests

  • food supplement based on a mixture of green tea extract and a pool of probiotics.
  • Placebo
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Where

1 site
COMEGEN Soc. Coop. Sociale
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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