Menthacarin® in the treatment of functional gastrointestinal disorders

The primary objective of this study is to systematically assess **symptom changes** and tolerability during treatment with Menthacarin in patients with **functional gastrointestinal disorders**. This evaluation is clinically relevant as it aims to determine the efficacy and safety of Menthacarin, which contains **peppermint oil** and **caraway oil**, in managing symptoms associated with these disorders. Additionally, the study seeks to explore the impact of treatment on quality of life and treatment satisfaction, which are critical factors in the overall management of functional gastrointestinal disorders. Furthermore, parameters related to gut permeability will be determined, providing insights into the potential mechanisms of action of the treatment.

The clinical trial involves a total of **50 participants** who are adults aged 18 years and older, comprising both male and female subjects. The study population is characterized by individuals diagnosed with **functional gastrointestinal disorders**, specifically those experiencing symptoms such as abdominal pain, cramping, bloating, or postprandial fullness. Participants were selected based on their ability to provide written informed consent and their willingness to comply with trial procedures. The trial does not include a vulnerable population. Lifestyle factors such as diet and physical activity are not specified, but participants must have experienced the aforementioned symptoms with a certain intensity over a specified period. The selection criteria ensure that the study focuses on individuals who can reliably report symptom changes and treatment tolerability, contributing to the assessment of the impact on quality of life and treatment satisfaction.

The clinical trial is designed to evaluate the efficacy and tolerability of **Menthacarin** in patients with **functional gastrointestinal disorders**. This study is a Phase IV, randomized, double-blind, controlled trial, aiming to systematically assess symptom changes and tolerability during treatment. The trial will also explore the impact on quality of life and treatment satisfaction, alongside parameters related to gut permeability. The trial is expected to last approximately one year, with an estimated recruitment start date of February 15, 2023, and an estimated end date of February 15, 2024.

Participants will be involved in the study for a maximum treatment period of eight weeks. The study will include several key visits: an initial screening visit, multiple follow-up visits, and an end-of-study visit. During the screening visit, eligibility will be confirmed based on criteria such as age (≥18 years), written informed consent, and the presence of specific abdominal symptoms. Follow-up visits will monitor symptom intensity, treatment adherence, and any adverse events. The end-of-study visit will assess the overall effectiveness and tolerability of the treatment.

Participants will be required to attend all scheduled visits and comply with trial procedures, including the completion of questionnaires and diaries, and blood drawing at two time points. The primary endpoints include symptom ratings using numeric scales, stool frequency and consistency, and global assessments of effectiveness and tolerability. The trial does not differentiate between primary and secondary outcome variables. Conditions that may lead to early termination from the study include non-compliance with trial procedures or the occurrence of significant adverse events. The trial is categorized as low intervention, as the investigational medicinal product is authorized and used within the terms of its marketing authorization, posing minimal additional risk to participants.

The clinical trial involves the administration of the experimental medication **Carmenthin bei Verdauungsstörungen**, which is formulated as a **gastro-resistant capsule, soft**. This medication contains the active substances **peppermint oil** and **caraway oil**, both of which are derived from structurally diverse herbal sources. The capsules are designed for **oral** administration. The maximum daily dose is 280 mg, with a total maximum dose of 16,800 mg over the course of the treatment. The treatment period is limited to a maximum of 8 weeks. The medication is manufactured by DR. WILLMAR SCHWABE GMBH & CO. KG and is not a pediatric formulation.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is solely on the administration of the experimental medication to assess its effects on functional gastrointestinal disorders. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the prescribed regimen.

Efficacy in the clinical trial of Menthacarin for the treatment of functional gastrointestinal disorders will be assessed using a variety of parameters. The primary endpoints include patient-reported symptom ratings on 11-point numeric rating scales, the sum of patient symptom ratings for all abdominal symptoms, and a global question on symptom impact. Additional assessments will include the most bothersome abdominal symptom, stool frequency via Frequency of Spontaneous Bowel Movements (SBMs), and stool consistency using the Bristol Stool Scale. Patient satisfaction with changes in bowel habits and a global assessment of effectiveness will be evaluated on a 5-point Likert scale. Furthermore, patient satisfaction will be measured using the Integrative Medicine Patient Satisfaction Scale (IMPSS), and quality of life will be assessed with the SF-12 Quality of Life Questionnaire. Serum parameters such as **Zonulin** and Intestinal-fatty acid binding protein (I-FABP) will also be measured, alongside adverse events and a global assessment of tolerability on a 5-point Likert scale.

The trial will systematically collect data through validated scales and questionnaires, with additional procedures including blood drawing at two time points. The trial is designed to explore the impact of Menthacarin on quality of life and treatment satisfaction, as well as to determine parameters related to gut permeability. The trial is categorized as a Phase IV study, indicating it is conducted post-marketing to gather further information on the drug's effectiveness and safety in a broader patient population. The trial is considered low intervention, as the investigational medicinal product (IMP) is used within the terms of its marketing authorization, and the additional procedures do not pose more than minimal additional risk or burden to the subjects compared to normal clinical practice.