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Tests treatment safety and results for Irritable Bowel Syndrome
Official title Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT07039747
What this study is testing
What is treatment with DIELEN® Protect?
treatment with DIELEN® Protect is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for irritable bowel syndrome.
Also referred to as Dielen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Irritable bowel syndrome (IBS) affects around 5% of the general population and remains a daily problem in clinicians' practices, with inconsistent efficacy of treatments despite patients' high expectations. Intestinal hyperpermeability and visceral hypersensitivity are the two major components of IBS, and both can disrupt gastrointestinal function and ultimately impair patients' quality of life.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 75
You may be able to join if
- Irritable bowel syndrome according to Rome IV criteria
- Aged between 18 and 75 years
- IBS-SSS \> 175 at inclusion
- For women of childbearing age, use of effective contraception (progestins or oestroprogestins or intrauterine device or tubal ligation) for 1 month...
- Irritable bowel syndrome treatments that have been stable for more than one month
You likely can't join if
- Taking probiotics, food supplements containing glutamine, anti-inflammatory drugs or antibiotics in the month preceding the study.
- Allergy to fish and glutamine
- Known renal insufficiency (Glomerular Filtration Rate (GFR)\<30mL/min/1.73m2), known hepatic insufficiency (Prothrombin Time (PT)\<70%) or known...
- History of organic digestive disease (coeliac disease, inflammatory bowel disease, abdominal surgery other than appendectomy or cholecystectomy)
- Pregnant women, women in labour or breastfeeding mothers
- Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship
See the full eligibility criteria
- Irritable bowel syndrome according to Rome IV criteria
- Aged between 18 and 75 years
- IBS-SSS \> 175 at inclusion
- For women of childbearing age, use of effective contraception (progestins or oestroprogestins or intrauterine device or tubal ligation) for 1 month unless postmenopausal (amenorrhoea of at least 12 months or...
- Irritable bowel syndrome treatments that have been stable for more than one month
- Membership of a social security scheme
- Patient has read and understood the information letter and signed the consent form
- Taking probiotics, food supplements containing glutamine, anti-inflammatory drugs or antibiotics in the month preceding the study.
- Allergy to fish and glutamine
- Known renal insufficiency (Glomerular Filtration Rate (GFR)\<30mL/min/1.73m2), known hepatic insufficiency (Prothrombin Time (PT)\<70%) or known cardiac disease.
- History of organic digestive disease (coeliac disease, inflammatory bowel disease, abdominal surgery other than appendectomy or cholecystectomy)
- Pregnant women, women in labour or breastfeeding mothers
- Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship
- Patient taking part in another trial / having taken part in another trial within a 4-week period
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, France, France
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, France, France. 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.