Clinical trial for proving the efficacy of heat-inactivated Bifidobacterium bifidum SYN-HI-001 in the treatment of irritable bowel syndrome

Not Applicable

Completed

• Conditions: Irritable bowel syndrome (IBS); Digestive System

• Registration Number: ISRCTN14066467
• Lead Sponsor: Synformulas GmbH

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32277872 (added 15/04/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-11
• Study Completion: 2017-04-15
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 507

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).