NCT04760353Completed
The Effect of a Probiotic Mixture in Obese Patients With Irritable Bowel Syndrome
The Effect of a Probiotic Mixture on the Symptoms and Fecal Microbiota in Obese Patients With Irritable Bowel Syndrome, Randomised, Double-blind, Controlled Study
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 26 Jan 2021
- Start date
- Nov 2021
- Primary completion date
- Oct 2025
- Lead sponsor
- University Hospital Rijeka
- Diseases
- Obesity
- NCT number
- NCT04760353
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From Nov 2021 to the primary completion date, Oct 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous abdominal surgery except for appendectomy, cholecystectomy and abdominal wall hernia repair
- History of participation in another clinical trial within 3 months before the onset of this trial
Other illness
- 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
- History of psychiatric disorder
Lab values
- 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.
- 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
Other
- Pregnancy or lactation
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Hospital Centre Coordinator of this site? Confirm its status | Rijeka | Croatia | Unknown status |
| University Hospital Rijeka Coordinator of this site? Confirm its status | Rijeka | Croatia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.