Upset stomach (functional dyspepsia) and related symptoms Digestive System
Conditions
Interventions
Treatment: 3 capsules (Lipase, Protease and antacid) of RM-001 per day for 4 weeks
Control: 3 capsules of placebo per day for 4 weeks
Randomisation: 1:1 randomisation i
Sponsors
Synformulas GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with upset stomach (functional dyspepsia) and related symptoms. A patient must fulfil the following: 1.1 One or more of the following symptoms occurs on at least 3 days per week with at least moderate intensity: - postprandial fullness - early satiation - gastric pain - gastric burning 1.2 Fulfillment of symptom criteria at recruitment (by history taking), and during the Run-in period of the study with onset of the symptoms more than 6 months prior to study start. 1.3 Presence of a malignant disease, which causes the dyspeptic symptoms, is to be excluded by the investigator on the basis of the current medical history and preliminary findings 2. Aged 18-80 years 3. Capacity for consent 4. Written informed consent of the patient 5. Understanding of the German language and compliance 6. Patient has understood, that changes in lifestyle and nutrition habits have to be avoided 7. Patient has understood the principle of the patient-diary and is willing to keep it according to the requirements 8. Negative pregnancy test in women capable of bearing children
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity towards enzymes or allergy to mould 2. Familial predisposition (first degree) with GI carcinoma if the presence of carcinoma has not been excluded by gastroscopy within the last 5 years 3. Acute or recurrent occurence of alarm symptoms (anemia, unintentional weight loss (>10% of body weight), fever, lymph node enlargement, hematemesis, vomiting, melena) 4. Organic diseases: esophagitis, GERD, Barrett's esophagus, gastritis, pancreatitis, exocrine pancreatic insufficiency 5. Other diseases: diabetes, chronic inflammatory bowel disease, diverticulitis, liver disease, disease of the genitourinary system, cholecystitis and presence of gallstones, dysphagia, odynophagia, ulcus in the digestive tract, malabsorption 6. Infectious and parasitic causes and acute infections and parasitic infection 7. Systemic diseases, current cancer diagnosis or cancer within the last 5 years or any cancer diagnosis of the upper digestive tract (esophagus, stomach, duodenum), autoimmune diseases 8. Hyperthyroidism and unstable hypothyroidism 9. Hypercalcemia, hypercalciuria, kidney stones or calcification of the kidney 10. Food intolerances, celiac disease 11. Current pathological abdominal palpation or ultrasound findings 12. Abdominal surgeries (exceptions include: appendectomies, hernia surgeries, cholecystectomy and sectio caesarea if undertaken more than 6 months prior to study start) 13. Psychiatric or eating disorders within the last 2 years 14. Medications that may affect the efficacy of the study product (e.g. prokinetics, proton pump inhibitors, H2 receptor antagonists, phytotherapeutics, antidepressants or psychotropic drugs (no use within the last 3 months), antibiotics (no intake within the last 2 months), systemic corticosteroids (no use within the last month), chronic use of NSAID (except ASA 100 mg as a blood thinner), thiazide-type diuretics, cardiac glycosides) 15. Predominant symptoms of irritable bowel syndrome (patient primarily suffering from defecation disorders such as diarrhea or constipation) 16. Predominant symptoms of reflux oesophagitis (patient primarily suffering from heartburn) 17. Pregnancy or lactation period 18. A need for care, guardian or immobilisation 19. Alcohol or drug abuse 20. Participation in other interventional trials or participation in other interventional trials within the last 30 days 21. Nonautonomous individuals, not capable of making decisions independently e.g. due to a relationship with a sponsoring party or relationship with a physician, both of whom may be capable of putting pressure on the participant 22. Accommodation in an asylum due to court or administrative order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate Relief Response, defined as reaching one of the best 3 categories on a 5 point Likert scale, assessed using the question "How would you assess the relief of your disease compared to before taking the test product?" on a weekly basis for the study duration. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are assessed using a patient diary: 1. Adequate Relief, assessed using a 5-point Likert scale on a weekly basis for the study duration 2. Overall Symptom Score (including assessment of postprandial fullness, early satiation, gastric pain, gastric burning, heart burn, belching, nausea, gastric cramps, bloating and flatulence), assessed using a 5-point Likert scale on a daily basis for the study duration 3. Individual symptoms of the Overall Symptom Score, assessed using a 5-point Likert scale on a daily basis for the study duration 4. Suffering by the single symptoms gastric pain, postprandial fullness, gastric burning and nausea, assessed using a 5-point Likert scale on a weekly basis for the study duration 5. Suffering by the totality of all symptoms, assessed using a 5-point Likert scale on a weekly basis for the study duration 6. Satisfaction with stomach activity, assessed using a 5-point Likert scale on a weekly basis for the study duration 7. Duration until onset of efficacy, assessed using a 5-point Likert scale on a daily basis for the study duration 8. Symptom Global Assessment (SGA), assessed using a 5-point Likert scale on a weekly basis for the study duration 9. Combination of Adequate Relief and Overall Symptom Score, assessed as described under 1. and 2. The following are assessed using a questionnaire at the physician visits: 10. Health-related quality of life, assessed using the SF-12 questionnaire at visit 2 (after the run-in phase and before the treatment phase) and visit 3 (after the treatment phase) 11. Efficacy of treatment assessed by patients and physician, assessed using a 5-point Likert scale at visit 3 12. Adequate Relief, assessed using a 5-point Likert scale at visit 3 13. Tolerance and safety assessed o | — |
Countries
Germany
Contacts
Public ContactSonja Henneberger
Outcome results
None listed