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
NCT ID: NCT07094035
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2025-07-30
2025-10-31
Brief Summary
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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.
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Detailed Description
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Study participants are between 18 and 70 years old and have symptoms of IBS-C for at least 3 months, with constipation problems such as going to the bathroom less than 3 times a week and often having hard stools. There are also criteria why some people will not be able to participate, such as those who have other intestinal diseases or take certain medications.
Participants will be randomly divided into two groups. One group will take the supplement with green tea and probiotics, the other group will take a placebo (an inactive substance that looks the same as the supplements). In particular, the study plans to recruit 64 subjects (32 subjects per group), who will be randomized into the following experimental groups:
GROUP 1 (32 subjects) subjects who will have to take the food supplement, an extract of green tea (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis) GROUP 2 (32 subjects) subjects who will have to take placebo. Each subject of the two experimental groups before, during and after the administration of the dietary supplement or placebo, will undergo the evaluation of the primary and secondary outcomes. Neither participants nor doctors will know who is taking what (double-blind study). Clinicians will collect information about participants symptoms through questionnaires.
Specifically, a questionnaire called IBS-SSS will be used to assess the overall severity of symptoms. Quality of life, stool consistency (using the Bristol Scale), frequency of bowel movements, frequency and intensity of specific symptoms such as bloating and pain, use of "rescue" medications (such as laxatives) and abdominal pain will also be taken into account. A small group of participants will also need to provide stool samples to analyze substances that indicate inflammation and to see if probiotics "colonize" the gut.
The data collected will be analyzed with statistical methods to compare the two groups and see if there are significant differences in symptoms.
The trial will be conducted at a single center: COMEGEN Soc. Coop. Sociale, located in Viale Maria Bakunin, 41 (Parco S. Paolo), 80126- Naples. The Principal Investigator of the study is Dr. Matteo Laringe, also affiliated with COMEGEN Soc. Coop. Social. Subjects enrolled in the study will be followed at this location for the duration of their participation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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GROUP 1: active group who will take verum
Subjects who will take the food supplement. 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.
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.
GROUP 2: subjects who will take PLACEBO
Subjects who will take daily: 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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* lactation
* HIV positive
18 Years
70 Years
ALL
No
Sponsors
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Adamas Biotech S.r.l.
INDUSTRY
Responsible Party
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Locations
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COMEGEN Soc. Coop. Sociale
Napoli, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IBS-THE-PROB25
Identifier Type: -
Identifier Source: org_study_id
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