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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

NCT07094035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-08-05

No results posted yet for this study

Summary

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

  • IBS, Constipation Predominant

Interventions

DIETARY_SUPPLEMENT

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

two 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.

DIETARY_SUPPLEMENT

Placebo

1 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.

Sponsors & Collaborators

  • Adamas Biotech S.r.l.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07094035 on ClinicalTrials.gov