Status:
COMPLETED
The Effect of a Probiotic Mixture in Obese Patients With Irritable Bowel Syndrome
Lead Sponsor:
University Hospital Rijeka
Collaborating Sponsors:
Institute AllergoSan
Conditions:
IBS - Irritable Bowel Syndrome
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of the current study is to evaluate the effect of a probiotic mixture on the adequate relief and faecal microbiota in obese patients with irritable bowel syndrome
Detailed Description
* The treatment period will last 8 weeks and after the treatment period, patients will be followed-up for another 2 weeks. Thus the overall trial period is the 10-week study period and end of 10th wee...
Eligibility Criteria
Inclusion
- Obese \[Body mass index (BMI) ≥30\] men or women with confirmed IBS (all subtypes based on Rome IV Diagnostic Criteria for IBS) aged between 18 and 65 years.
- Written informed consent.
Exclusion
- Pregnancy or lactation
- Severe systemic illness \[cancer, gastrointestinal illness (e.g., colitis, Crohn's disease, celiac disease, recurrent diverticulitis), chronic renal failure, an endocrine disorder, metabolic disorder, angina, congestive heart failure, uncontrolled hypertension\] or severely impaired general health
- Organic abnormality which is excluded by full blood count, C-reactive protein or erythrocyte sedimentation rate, and thyroid-stimulating hormone for constipated IBS participants. To exclude other organic lower gastrointestinal disease faecal calprotectin will be checked, and celiac test and colonoscopy will be performed if needed.
- Previous abdominal surgery except for appendectomy, cholecystectomy and abdominal wall hernia repair
- History of psychiatric disorder
- History of participation in another clinical trial within 3 months before the onset of this trial
- Medications that could affect the outcomes: oral steroid, sulfasalazine, cholestyramine, misoprostol and probiotics usage 3 months prior to and during the study; and antacids with magnesium or aluminium usage during the study
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04760353
Start Date
November 10 2021
End Date
October 17 2025
Last Update
November 19 2025
Active Locations (2)
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1
Clinical Hospital Centre
Rijeka, Croatia, Croatia, 51000
2
University Hospital Rijeka
Rijeka, Rijeka, Croatia, 51000