BridgeMD
New treatment option for Irritable Bowel Syndrome
Official title Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients
ClinicalTrials.gov ID: NCT07235228
What this study is testing
- What it's testing
- Multi-center, randomized, double-blind, placebo-controlled, 12 weeks trial investigating the effects of a nine-strain synbiotic (Vivatlac Synbiotikum) on the gut microbiota of IBS patients
- 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 65
You may be able to join if
- diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for Health Care Providers of the World Global Gastroenterology Organization
- IBS severity assessed with the IBS-Severity Scoring System (IBS-SSS) being ≥ 175 points (indicating medium or severe IBS).
You likely can't join if
- patients currently taking products containing probiotics or have taken this kind of products during the last 3 months
- patients currently taking antibiotics or have taken antibiotics during the last 3 months
- patients having a concurrent severe illness (malignancies, uncontrolled hypertension or diabetes, hepatic, renal or cardiac dysfunctions, serious...
- patients having chronic bowel disorders other than IBS, including inflammatory bowel disease, gastroenteritis, stomach and duodenal cancer, celiac...
- patient being tested positive for presence of Clostridioides difficile
- patient being pregnant, lactating, or planning to become pregnant during the next 3 months
See the full eligibility criteria
- diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for Health Care Providers of the World Global Gastroenterology Organization
- IBS severity assessed with the IBS-Severity Scoring System (IBS-SSS) being ≥ 175 points (indicating medium or severe IBS).
- patients currently taking products containing probiotics or have taken this kind of products during the last 3 months
- patients currently taking antibiotics or have taken antibiotics during the last 3 months
- patients having a concurrent severe illness (malignancies, uncontrolled hypertension or diabetes, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma...
- patients having chronic bowel disorders other than IBS, including inflammatory bowel disease, gastroenteritis, stomach and duodenal cancer, celiac disease
- patient being tested positive for presence of Clostridioides difficile
- patient being pregnant, lactating, or planning to become pregnant during the next 3 months
- patient being diagnosed to have a lactose intolerance
- patients using motility drugs or dietary fiber supplements withing 2 weeks before study start
- patient taking anti-coagulant medication
- patients have participated in another clinical trial within the last three months
The study team makes the final eligibility decision.
Where it's taking place
- Jarocin, Poland
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jarocin, Poland. 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.