BridgeMD
Menthacarin® in the treatment of functional gastrointestinal disorders
EU CTIS ID: 2022-501800-92-00
What this study is testing
The objectives are to systematically assess symptom changes and tolerability during treatment with Menthacarin and to explore their impact on quality of life and treatment satisfaction in a broad population of patients with functional gastrointestinal disorders. Furthermore, parameters related to gut permeability will be determined.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult male or female subject (≥18 years old)
- Written informed consent in accordance with the legal requirements is voluntarily provided by the patient prior to the beginning of any trial-related tasks or investigations
- Patient with willingness and ability to comply with all trial procedures and to attend all scheduled visits at the investigational site
- Patient suffering from a functional gastrointestinal disorder: Patient suffers from at least one of the following functional abdominal symptoms at least 1 day/week for ≥ 3 months on: - abdominal pain/cramping - bloating feeling
- The presence of at least one of the functional abdominal symptoms - abdominal pain/cramping - bloating feeling - postprandial fullness with an intensity of ≥ 4 points on a 0-10 points numeric rating scale (NRS) on at least one day within the last week prior to visit 1 (assessed retrospectively at visit 1)
- At visit 2 only: At least one of the functional abdominal symptoms - abdominal pain/cramping - bloating feeling - postprandial fullness assessed already at visit 1 with an intensity of ≥ 4 points on a 0-10 NRS, was present on at least one day within the last week prior to visit 2 with an intensity of ≥ 4 points on a 0-10 NRS (documented by daily diary assessment).
You likely can't join if
- Patient in whom abdominal symptoms are caused by an organic cause.
- Patient is immunocompromised (e.g. AIDS, lymphoma, long-term corticosteroid treatment).
- Patient with a malignant disease or undergoing chemotherapy or radiation therapy
- Patient with known or suspected history of alcohol or drug abuse according to the opinion of the investigator
- Female patient who is pregnant, breast-feeding or planning pregnancy during the course of this clinical trial
- Female patient of child-bearing potential not using or not willing to use consistently and correctly throughout the duration of this clinical trial one of the following contraceptive methods: established use of implants, injectables, or combined hormonal oral, intravaginal or transdermal contraceptives, placement of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), sexual abstinence and vasectomised partner
See the full eligibility criteria
Who can join
- Adult male or female subject (≥18 years old)
- Written informed consent in accordance with the legal requirements is voluntarily provided by the patient prior to the beginning of any trial-related tasks or investigations
- Patient with willingness and ability to comply with all trial procedures and to attend all scheduled visits at the investigational site
- Patient suffering from a functional gastrointestinal disorder: Patient suffers from at least one of the following functional abdominal symptoms at least 1 day/week for ≥ 3 months on: - abdominal pain/cramping - bloating feeling
- The presence of at least one of the functional abdominal symptoms - abdominal pain/cramping - bloating feeling - postprandial fullness with an intensity of ≥ 4 points on a 0-10 points numeric rating scale (NRS) on at least one day within the last week prior to visit 1 (assessed retrospectively at visit 1)
- At visit 2 only: At least one of the functional abdominal symptoms - abdominal pain/cramping - bloating feeling - postprandial fullness assessed already at visit 1 with an intensity of ≥ 4 points on a 0-10 NRS, was present on at least one day within the last week prior to visit 2 with an intensity of ≥ 4 points on a 0-10 NRS (documented by daily diary assessment).
What rules you out
- Patient in whom abdominal symptoms are caused by an organic cause.
- Patient is immunocompromised (e.g. AIDS, lymphoma, long-term corticosteroid treatment).
- Patient with a malignant disease or undergoing chemotherapy or radiation therapy
- Patient with known or suspected history of alcohol or drug abuse according to the opinion of the investigator
- Female patient who is pregnant, breast-feeding or planning pregnancy during the course of this clinical trial
- Female patient of child-bearing potential not using or not willing to use consistently and correctly throughout the duration of this clinical trial one of the following contraceptive methods: established use of implants, injectables, or combined hormonal oral, intravaginal or transdermal contraceptives, placement of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), sexual abstinence and vasectomised partner
- Patient exhibiting or indicating thoughts of suicide currently or in the past
- Planned surgical intervention during the clinical trial
- Previous inclusion in the present clinical trial
- Patient participating in another clinical trial at the same time, or has taken part in a clinical trial within the last 30 days before inclusion in the present clinical trial
- Patient unable to read and / or write
- Patient with constipation and/or changes in bowel movements alternating between normal bowel movements and constipation
- Patient who are members of the staff of the trial site, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator
- Evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
- Patient is currently experiencing bloody diarrhoea
- Known hypersensitivity to peppermint, menthol, caraway, to umbelliferous plants or other ingredients of the investigational medicinal product
- Concomitant use of any other treatments for functional gastrointestinal disorders, including herbal preparations (other than the investigational medicinal product)
- Patient is suffering from reduced production of gastric acid (achlorhydria)
- Liver diseases
- Gallstones, inflammation of the bile duct (cholangitis) or other diseases of the gall
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. 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 EU CTIS; the study team decides eligibility.