Obesity Clinical Trial
Official title:
The Effect of a Probiotic Mixture on the Symptoms and Fecal Microbiota in Obese Patients With Irritable Bowel Syndrome, Randomised, Double-blind, Controlled Study
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 | Recruiting |
Enrollment | 100 |
Est. completion date | October 10, 2024 |
Est. primary completion date | August 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Clinical Hospital Centre | Rijeka | Kresimirova 42 |
Croatia | University Hospital Rijeka | Rijeka |
Lead Sponsor | Collaborator |
---|---|
University Hospital Rijeka | Institute AllergoSan |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | IBS Severity | IBS severity will be assessed by the IBS symptom severity score (IBS SSS) questionnaire administered at the trial site by gastroenterologists and filled by patients at the time of randomization (0 weeks) and at the end of treatment (8th week). IBS-SSS consists of five items [abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QOL)], and each measure is rated from 0 to 100, with total scores ranging from 0 to 500. Participants with scores of <175, 175-300, and >300 are classified as mild, moderate, and severe groups. | eight weeks | |
Other | IBS QOL | IBS health related quality of life (QoL) will be assessed by IBS-36 questionnaire administered at the trial site by gastroenterologists and filled by patients at the time of randomization (0 week) and at the end of treatment (8th week). The IBS-36 consists of 36 questions scored on a 7-point Likert scale ranging from 0 through to 6, giving a maximal total score of 216. A final score is a sum of the scores of the 36 questions, with question 18 being reverse scored (i.e., for a patient score of 0, a score of 6 is entered). This instrument is negatively scored (i.e., a lower score equates to a better QoL) and assesses patients' symptoms over a last 2 months. | eight weeks | |
Other | Psychological distress | Psychological distress will be assessed by Hospital Anxiety and Depression Scale (HADS) questionnaire administered at the trial site by gastroenterologists and filled by patients at the time of randomization (0 week) and at the end of treatment (8th week). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. | eight weeks | |
Primary | Adequate relief | Adequate relief (AR) related question of overall IBS symptoms "In the past 7 days have you had adequate relief of your IBS pain and discomfort?" which will be assessed weekly for 10 weeks (starting with 0 week till 10th week). A responder is defined as a patient who experiences AR (answers YES to AR related question) for at least 50% of the 10-week study period (5 of the 10 weekly assessments). 10-point analog scale will be used for the measurement of response rate among patients in each group. | eight weeks | |
Secondary | The fecal flora compositions | The fecal flora compositions will be analyzed by Real Time polymerase chain reaction (PCR) for specific strain detection. The concordance rate of each patient's denaturing gradient gel electrophoresis (DGGE) profile before and after the treatment will be measured by the visual scale where each band of the DGGE profile represents a different organism and the similarity of band locations represents the same composition of the population of organisms. | eight weeks |
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