Green tea extract plus probiotic supplement for constipation-predominant IBS

Efficacy Study of a Food Supplement Based on an Extract of Green Tea (Camellia Sinensis (L.) Kuntze - Folium) and a Pool of Probiotics (L. Plantarum, L. Rhamnosus and B. Animalis Subsp. Lactis) for the Management of Gastrointestinal Discomfort and for the Maintenance of the Balance of Intestinal Function in Subjects With Irritable Bowel Syndrome (Irritable Bowel Syndrome - IBS) With Predominance of Constipation (IBS-C): Single-center, Controlled, Randomized, Parallel-arm, Double-blind Clinical Trial.

This trial tests whether a daily supplement combining green tea extract and probiotics can help adults with constipation-predominant IBS have fewer symptoms and more regular, comfortable bowel movements.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Adamas Biotech S.r.l. (Industry-sponsored)
• Locations: 1 site (Naples)
• Trial ID: NCT07094035 on ClinicalTrials.gov

What this trial studies

This is a randomized, placebo-controlled trial enrolling 64 adults with IBS-C to compare a food supplement containing green tea extract and a mix of probiotics versus placebo. Participants aged 18–70 who meet Rome IV criteria for IBS-C and have symptoms for at least 3 months will be assigned to one of the two groups. Outcomes include overall patient-reported gastrointestinal symptom improvement, stool consistency and frequency, abdominal pain, use of rescue treatments, and impact on quality of life. Assessments occur before, during, and after the supplementation period to measure changes over time.

Who should consider this trial

Good fit: Adults 18–70 years old meeting Rome IV criteria for constipation-predominant IBS with symptoms for at least 3 months and fewer than three bowel movements per week are appropriate candidates.

Not a fit: People with other intestinal diseases, recent use of excluded medications, pregnant or breastfeeding people, or those outside the 18–70 age range may not benefit or may be ineligible.

Why it matters

Potential benefit: If successful, the supplement could reduce constipation symptoms, improve stool form and bowel frequency, and improve quality of life for people with IBS-C.

How similar studies have performed: Previous trials of probiotics and botanical extracts have produced mixed, generally modest benefits for IBS symptoms, and this specific green tea plus probiotic combination has limited direct evidence.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Where this trial is running

Naples

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

Study contacts

• Study coordinator: Alessandra Baldi

Conditions IBS, Constipation Predominant; IBS, constipation predominant; Food Supplement; Green tea extract; probiotics