Status:
COMPLETED
Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome
Lead Sponsor:
Children's Memorial Health Institute, Poland
Collaborating Sponsors:
Medical University of Lublin
Conditions:
Irritable Bowel Syndrome With Diarrhea
Effects of Probiotics
Eligibility:
All Genders
16-70 years
Phase:
NA
Brief Summary
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits without ...
Eligibility Criteria
Inclusion
- diarrhea-predominant irritable bowel syndrome (IBS-D)
- at least moderate form of IBS-D assessed using IBS-SSS, i.e. with score \>175
- male and female subjects of Caucasian race
- age between 16 and 70 years (inclusive)
- good physical, medical and mental status estimated on the basis of the medical history and a general clinical examination
- results of laboratory tests (hematology, clinical chemistry, serology, and urinalysis) within the normal range of the local laboratory or considered non-clinically significant by the investigator
- patients who have provided freely their own written informed consent
- patients available for the whole study period
- patients who are able to follow strictly the instructions of the investigational team regarding the study procedures and to fulfil the requirements of the protocol
- the following medications are permitted during the course of the study, as long as they are used at a constant dosage and are commenced at least 1 month prior to study start: birth control pill, or depot intramuscular contraceptive preparation, estrogen-progesterone replacement therapy, L-thyroxine, low-dose antidepressants (up to 25 mg day of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), low-dose antihypertensives in the diuretic, angiotensin-converting enzyme inhibitor or angiotensin II inhibitor classes
- patients are allowed to take spasmolytic drugs on an ad hoc basis
Exclusion
- other than IBD-D types of IBD
- mild type of IBS-D (\<175 points in IBS-SSS scale)
- the use of probiotics within last three months
- the treatment with antibiotics within last three months
- a concurrent severe illness (malignancies, uncontrolled hypertension and diabetes mellitus, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma, chronic obstructive pulmonary disease, hyper- or hypothyroidism)
- chronic bowel disorders other than IBS, including inflammatory bowel diseases, gastroenteritis, stomach and duodenal ulcers, celiac diseases;
- pregnancy or lactation
- diagnosed lactose intolerance
- the use of motility drugs or dietary fiber supplements within 2 weeks before study start
- plan to have surgery during the time of the study
- a history of alcohol or drug abuse
- taking anti-coagulant medications
- participation in another clinical trial within last three months
- patients who will receive antibiotics during the study
Key Trial Info
Start Date :
November 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04662957
Start Date
November 2 2019
End Date
May 31 2020
Last Update
December 16 2020
Active Locations (1)
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1
The Children's Memorial Health Institute
Warsaw, Poland, 04-730