Chronic idiopathic constipation Digestive System Chronic idiopathic constipation
Conditions
Interventions
Participants are randomised using block randomisation in a 1:1 ratio to either the treatment group or the control group. The treatment group will receive 3 portions of SYN-001 (with Synformularis2 Fas
Sponsors
Synformulas GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with chronic idiopathic constipation according to current EMA-Guideline: 1.1. A patient must fulfil 2 or more of the following 3 criteria: 1.1.1. Fewer than 3 defecations per week 1.1.2. Straining during at least 25% of defecations 1.1.3. Lumpy or hard stools in at least 25% of defecations 1.2. A patient must fulfil all of the following: 1.2.1. Loose stools (type 6 or 7 on the Bristol Stool Scale) are rarely present without the use of laxatives at visit 1 and occurs during the run-in period on less than 3 days 1.2.2. No defecation disorders 1.2.3. Insufficient criteria for irritable bowel syndrome according to the Rome III criteria 1.2.4. No other causes are identifiable for constipation (e.g. medication) These criteria should be fulfilled at recruitment (by history taking), and during the run-in period of the studies. In addition to that, during the Run-In period, the number of stools should not exceed 5 in two weeks. 2. Otherwise healthy 3. Aged 18-80 years 4. Negative result of a sigmoidoscopy or colonoscopy within the preceding 5 years for patients above 55 years of age 5. Legal capacity 6. Written consent of the patient 7. Understanding of the German language and compliance 8. Understanding that changes in lifestyle and nutrition habits have to be avoided 9. Understanding the principle of the patient diary and is willing to keep it according to the requirements 10. Negative pregnancy test in women capable of bearing children
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity towards the study product or Bisacodyl 2. New symptoms during the last weeks, such as anemia, rectal bleeding, positive fecal occult blood test or severe weight loss 3. Secondary reasons for constipation: 3.1. Intake of medicaments (e.g. opioids, tricyclic antidepressants, duretics) 3.2. Organic/metabolic/neurological diseases (e.g. hypercalcemia, anemia, dementia, collagenosis, Parkinson's disease, multiple sclerosis, Hirschsprung's disease) 3.3. Bowel dysfunction (e.g. structural intestinal passage disorder, bowel obstruction, slow-transit-constipation, intestinal stenosis) 3.4. Eating disorders (e.g. anorexia, bulimia) 3.5. Physical inactivity 3.6. Eating disorder 4. Fluid intake of <0.5 l of fluid per day 5. Inadequate response to usual laxatives (psyllium, sauerkraut juice, Dulcolax, Lefax, Lacoberal, Bisacodyl) 6. Inflammatory bowel diseases (Crohn's disease and Ulcerative colitis) 7. Systemic diseases, cancer, autoimmune diseases 8. Known abnormalities in abdomen region e.g. unusual ultrasound that would require further investigation 9. Ileus, bowel obstruction or acute surgical conditions 10. Defecation disorders 11. Irritable bowel syndrome 12. Surgical intervention within the next 3 months 13. Current cancer diagnosis or cancer within the last 5 years or any colorectal cancer diagnosis 14. Ingestion of any of the following: 14.1. Opioids within the last 6 months prior to study start 14.2. Antipsychotics/antideperessants within the last 3 months prior to study start 14.3. Antibiotics within the last 2 months prior to study star 14.4. Systemic corticosteroids within the last month prior to study start 14.5. Medications that may affect the efficacy of the study product (e.g. analgesics, antibiotics, chemotherapeutics, psychotropics/antidepressants, laxatives, spasmolytics, antidiarrhoeals, probiotic products) 15. Serious psychiatric disorders within the last 2 years 16. Diabetes mellitus 17. Hyperthyroidism and non-set hypothyroidism 18. Immune deficiency 19. Abdominal surgeries (exceptions include: appendectomies, hernia surgeries, cholecystectomy and sectio caesarea if undertaken more than 6 months prior to study start) 20. Coeliac disease 21. Fever 22. Known parasites or eggs in stool 23. Serious diseases resulting in a need for care, a need for a guardian or resulting in immobilisation 24. Gynecological diseases 25. Alcohol or drug abuse 26. Pregnancy or lactation period 27. Participation in other interventional trials or participation in other interventional trials within the last 30 days 28. 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 pressuring the participant 29. Accommodation in an asylum due to court or administrative order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate, based on complete spontaneous bowel movements (CSBMs) per week, assessed using a patient diary (using the question "How many CSBMs have you had within the last 24 hours?") on a daily basis | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are assessed using a patient diary: 1. Frequency of CSBMs, assessed using the question "How many CSBMs have you had within the last 24 hours?" on a daily basis for the study duration 2. Stool consistency, assessed using the Bristol Stool Form Scale (BSFS) on a daily basis for the study duration 3. Pain during defecation, straining during defecation, sensation of bloating and flatulence, assessed using a 5-point Likert scale on a daily basis for the study duration 4. Number of symptom-free days, assessed on a daily basis for the study duration 5. Subjective assessment of weight change, assessed using a 5-point Likert scale on a weekly basis for the study duration 6. Use of emergency medication (Bisacodyl suppositories), assessed on a daily basis for the study duration 7. Satisfaction of bowel function, assessed using a 5-point Likert scale on a weekly basis for the study duration 8. Suffering from constipation, sensation of bloating and flatulence, assessed using a 5-point Likert scale on a weekly basis for the study duration 9. Adequate relief and adequate relief responder, assessed using a 5-point Likert scale on a weekly basis for the study duration The following are assessed using a questionnaire at the physician visits: 10. Subjective assessment by patients and physician of efficacy of treatment, assessed using a 5-point Likert scale at visit 3 11. Quality of life, assessed using the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL) at visit 2 (after the run-in phase and before the treatment phase) and visit 3 (after the treatment phase) 12. Weight change, assessed using a weighing scale at visits 1, 2 and 3 13. Abdominal girth change, assessed using a measuring tape at visits 1, 2 and 3 | — |
Countries
Germany
Contacts
Public ContactSonja Henneberger
Outcome results
None listed