Probiotic treatment for 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
This study is testing a special probiotic mix to see if it can help relieve symptoms for obese patients with irritable bowel syndrome over 8 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital Rijeka Academic / other |
| Locations | 2 sites (Rijeka and 1 other locations) |
| Trial ID | NCT04760353 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a specific probiotic mixture on symptom relief and changes in fecal microbiota among obese patients diagnosed with irritable bowel syndrome (IBS). The treatment lasts for 8 weeks, followed by a 2-week follow-up period. Participants will have scheduled visits with gastroenterologists and will be monitored for any adverse reactions or additional IBS management needs. Assessments will include laboratory tests and anthropometric measurements to gauge the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 18 to 65 with a confirmed diagnosis of IBS.
Not a fit: Patients with severe systemic illnesses or organic gastrointestinal abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant symptom relief and improve gut health for obese patients suffering from IBS.
How similar studies have performed: Previous studies have shown promising results with probiotic treatments for IBS, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Rijeka and 1 other locations
- Clinical Hospital Centre — Rijeka, Croatia (Recruiting)
- University Hospital Rijeka — Rijeka, Croatia (Recruiting)
Study contacts
- Principal investigator: GORAN HAUSER, MD, PhD — KBC Rijeka; Medicinski fakultet Sveučilišta u Rijeci
- Study coordinator: GORAN HAUSER, MD, PhD
- Email: goran.hauser@uniri.hr
- Phone: 0981820726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.