Actively Recruiting
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
Led by Adamas Biotech S.r.l. · Updated on 2025-08-05
64
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 70 years
- Able to understand and sign informed consent
- HIV negative test
- Negative pregnancy test
- 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: related to defecation, change in bowel movement frequency, change in stool shape (Rome IV criteria)
- Less than three bowel movements per week and at least one of the following in more than 25% of defecations: straining, lumpy or hard stools (Bristol Stool Form Scale type 1 or 2), feeling of incomplete evacuation, anorectal obstruction, manual maneuvers to facilitate evacuation
- Able to understand and comply with protocol requirements
You will not qualify if you...
- Pregnancy
- Lactation
- HIV positive
- Do not meet inclusion criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
COMEGEN Soc. Coop. Sociale
Naples, Italy, 80126
Actively Recruiting
Research Team
A
Alessandra Baldi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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