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New treatment option for IBS, Constipation Predominant
Official title 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
ClinicalTrials.gov ID: NCT07094035
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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)
You likely can't join if
- pregnancy
- lactation
- HIV positive
- do not meet inclusion criteria.
See the full eligibility 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...
- 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.
- pregnancy
- lactation
- HIV positive
- do not meet inclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.