The Effect of a Probiotic Mixture in Obese Patients With Irritable Bowel Syndrome

Launched by UNIVERSITY HOSPITAL RIJEKA · Feb 14, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how a special mixture of probiotics, which are beneficial bacteria, can help relieve symptoms in obese patients who have Irritable Bowel Syndrome (IBS). IBS can cause various digestive issues, and the researchers hope that this probiotic mixture might provide some relief and improve gut health in participants. The study is currently recruiting individuals aged 18 to 65 who are obese, with a body mass index (BMI) of 30 or higher, and have a confirmed diagnosis of IBS.

To join the trial, participants must be willing to provide written consent and meet certain health criteria. Those who are pregnant, have serious health conditions, or have had specific surgeries might not be eligible. Participants can expect to take the probiotic mixture and may undergo tests to monitor their health and gut bacteria. This trial is important because it seeks to find new ways to help manage IBS symptoms in people who also struggle with obesity, potentially leading to better treatment options in the future.

Gender

ALL

Eligibility 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