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 | Recruiting

• 1 other identifier: IBS-THE-PROB25
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IBS, constipation predominant; Food Supplement; Green tea extract; probiotics

Outcome Measures

Primary Outcomes (1)

• Efficacy of the food supplement in the overall improvement of perceived gastrointestinal symptoms.

  Validated questionnaire for self-assessment of the severity of global gastrointestinal symptomatology characterizing IBS, IBS Severity Scoring System (IBS-SSS). The questionnaire consists of 5 items referring to: abdominal pain, bowel dysfunction and general well-being. It is commonly used as an outcome measure in clinical efficacy trials, due to its high sensitivity following treatment. The total score obtained allows to determine the severity of global gastrointestinal symptoms, whether IBS-related symptoms are mild, moderate or severe and whether, following treatment, there is an improvement in global symptoms in the treated group compared to the placebo group.

  [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]

Secondary Outcomes (8)

• Assessment of the impact of constipation on perceived quality of life in the last 4 weeks

  [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]

• The effectiveness in improving stool consistency.

  [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]

• The effectiveness of the frequency of bowel movements.

  [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]

• The efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS.

  [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]

• The effectiveness of the decrease in frequency in the use of salvage treatments.

  [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]

Study Arms (2)

GROUP 1: active group who will take verum

EXPERIMENTAL

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.

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

GROUP 2: subjects who will take PLACEBO

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

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

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 1: active group who will take verum

Placebo DIETARY_SUPPLEMENT

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.

GROUP 2: subjects who will take PLACEBO

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Adamas Biotech S.r.l.: lead

Study Sites (1)

COMEGEN Soc. Coop. Sociale

Napoli, 80126, Italy

RECRUITING

MeSH Terms

Conditions

Ichthyosis Bullosa of Siemens

Condition Hierarchy (Ancestors)

Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Alessandra Baldi

CONTACT

+393483854114; alessandra.baldi.alimenti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: July 30, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)