Efficacy And Safety Of Enterogermina Vs Placebo In Adults With Small Intestinal Bacterial Overgrowth (SIBO)
- Conditions
- Small intestinal bacterial overgrowth (SIBO)MedDRA version: 20.0Level: LLTClassification code 10071061Term: Small intestinal bacterial overgrowthSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-001355-12-IT
- Lead Sponsor
- SANOFI-AVENTIS GROUPE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 214
- Male and female patients aged >/=18 years.
- Small intestinal bacterial overgrowth diagnosed based on positive hydrogen breath test (GBT or LBT) as described in The North American Consensus within 2 weeks prior to study entry.
- Patients reporting recurrent bloating or feeling of abdominal distension, defined as recurrent feeling of bloating or visible distension at least 3 days/month in the last month.
- Patients presenting abnormal stool frequency (abnormal is defined as >3 bowel movements/day and <3 bowel movements/week) and/or abnormal stool form (lumpy/hard or loose/watery stool) as per the Bristol-Stool scale.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 214
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- History of intestinal surgery (except cholecystectomy and appendectomy).
- Use of antibiotic or probiotics (medications or dietetic supplements) in the last month prior to study entry.
- Standard medication consisting of laxative or antidiarrheal.
- Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, mania, or major psychiatric illnesses needing pharmacological treatment. Well-compensated depression does not exclude a potential patient.
- Patients not able to maintain their usual diet and lifestyle during the course of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Enterogermina (Bacillus clausii [B clausii] probiotic strain) versus placebo for small intestinal bacterial overgrowth (SIBO) eradication.;Secondary Objective: To evaluate the safety and tolerability of Enterogermina (B clausii) versus placebo in treating patients with SIBO.;Primary end point(s): SIBO eradication: percentage of patients with small intestinal bacterial overgrowth (SIBO) eradication, wherein patients present a negative glucose hydrogen breath test (GBT) after 30 days of treatment.;Timepoint(s) of evaluation of this end point: Up to Day 30
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. SIBO-associated symptoms (patient assessment): relief of SIBO associated symptoms such as abdominal discomfort, bloating, abdominal cramps, and stool frequency impairment.<br>2. Relief of overall gastrointestinal symptoms: patient satisfaction rating of symptom improvement (satisfactory relief of overall gastrointestinal symptoms).<br>3. Quality of Life (QoL)questionnaire: QoL assessed by 12-Item Short Form Survey (SF-12) questionnaire.<br>4. Adverse Events: number of patients with adverse events.;Timepoint(s) of evaluation of this end point: 1. Up to Day 30<br>2. On Day 30<br>3. Up to Day 30<br>4. Up to Day 30