Irritable bowel syndrome (IBS) Digestive System Irritable bowel syndrome (IBS)
Conditions
Interventions
Current interventions as of 05/08/2019:
Participants are block randomised into two groups in a 1:1 ratio.
Treatment group: Participants take two capsules containing he
Sponsors
Synformulas GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with IBS, diagnosed according to the Rome-III-criteria 2. Otherwise healthy male or female subjects, aged between 18 and 65 years 3. Negative result of a sigmoidoscopy or coloscopy within the preceding 5 years for patients above 55 years of age 4. Legal capacity 5. Written consent of the patient 6. Understanding of the German language and compliance 7. Patient has understood, that changes in life style and nutrition habits have to be avoided 8. Patient has understood the principle of the patient-diary and is willing to keep it according to the requirements 9. Negative pregnancy test
Exclusion criteria
Exclusion criteria: 1. Inflammatory bowel diseases (Crohn's disease and Ulcerative colitis) 2. Systemic diseases, cancer, autoimmune diseases 3. Known abnormalities in abdomen region e.g. unusual ultrasound that would require further investigation 4. Ingestion of antipsychotics within the last 3 months prior to the start of the study. Ingestion of systemic Corticosteroids wihtin the last month prior to the start of the study. 5. Ingestion of medication influencing the efficacy of the tested product (i.e. analgetics, antibiotics, chemotherapeutics, antipsychotics, laxatives, spasmolytics, antidiarrhoeals) 6. Ingestion of other probiotic products 7. Serious psychiatric disorders within the last 2 years 8. Diabetes mellitus 9. Hyperthyroidism and hypothyroidism 10. Lactose intolerance or other malabsorption syndromes 11. Immune deficiency 12. Abdominal surgeries (exceptions include: appendectomies, hernia surgeries, cholecystectomy, sectio caesarea) 13. Coeliac disease 14. Known positive stool culture for patients with diarrhea-predominant IBS 15. Fever 16. Known parasites or eggs in stool 17. Laboratory abnormalities which would expose the patient to an unacceptable risk or influence intepretation of study data 18. Serious diseases resulting in a need for care, a need for a guardian or resulting in immobilisation 19. Alcohol or drug abuse 20. Pregnancy or lactation period 21. Participation in other interventional trials or participation in other interventional trials within the last 30 days 22. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response-rate based on adequate relief of IBS symptoms in combination with an improvement in abdominal pain at the end of the treatment phase, adequate relief of IBS symptoms is measured weekly for 10 weeks (during the treatment phase and the wash out phase) using the 7-point Likert scale, abdominal pain is measured daily for 12 weeks using the 11-point numerical rating scale (NRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/08/2019: 1. Response-rates of the single parameters of the combined endpoint, adequate relief of IBS symptoms is measured weekly for 10 weeks (during the treatment phase and the wash out phase) using the 7-point Likert scale, abdominal pain is measured daily for 12 weeks using the 11-point numerical rating scale (NRS). 2. Change in Mental Health Sum is measured using the SF-12 health survey at baseline and at the end of treatment. Previous secondary outcome measures: 1. Response-rates of the single parameters of the combined endpoint, adequate relief of IBS symptoms is measured weekly for 10 weeks (during the treatment phase and the wash out phase) using the 7-point Likert scale, abdominal pain is measured daily for 12 weeks using the 11-point numerical rating scale (NRS) 2. Subject’s global assessment of symptoms, measured daily for 12 weeks using the 7-point Likert scale 3. Spontaneous bowel movements (numerically), stool consistency (using the Bristol Stool Form Scale), and feeling of incomplete evacuation (numerically), measured daily for 12 weeks 4. Mucus and blood in stool, measured numerically on a weekly basis for 12 weeks 5. Symptom-free and pain-free days, assessed daily for 12 weeks using the 7-point Likert scale of the subject’s global assessment of symptoms and the 11-point numerical rating scale of abdominal pain measurement 6. Severity of IBS symptoms, measured at visits 2, 3, 4 and 5 using the IBS-severity symptom system (IBS-SSS) score 7. Quality of life, measured at visits 2, 3 and 4 using the SF-12 health survey 8. Safety, using results of vital parameters (measured at visits 1, 2, 3, 4 and 5), blood samples (collected at visits 1 and 5), adverse events (assessed at visits 1, 2, 3, 4 and 5) and subjective assessment of tolerabilit | — |
Countries
Germany
Contacts
Public ContactSonja Henneberger
Outcome results
None listed