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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: IBS, Constipation Predominant

In brief

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.

Key facts

Study ID

NCT07094035

Run by

Adamas Biotech S.r.l.

People needed

64

Starts

2025-07-30

Expected to finish

2025-10-01

Last updated by the study team

2025-08-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• pregnancy
• lactation
• HIV positive
• do not meet inclusion criteria.

Where it is running

• COMEGEN Soc. Coop. Sociale — Naples, Italy (enrolling)

Full record on ClinicalTrials.gov

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