Efficacy And Safety Of Enterogermina Vs Placebo In Adults With Small Intestinal Bacterial Overgrowth (SIBO)

Phase IV, randomized, double-blind, multicenter, placebo-controlled clinical trial to evaluate the efficacy and the safety of enterogermina (Bacillus clausii) in treating patients with small intestinal bacterial overgrowth - BASTA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001355-12-IT

Enrollment

214

Registered

2020-10-16

Start date

2019-02-27

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small intestinal bacterial overgrowth (SIBO) MedDRA version: 20.0 Level: LLT Classification code 10071061 Term: Small intestinal bacterial overgrowth System Organ Class: 100000004862

Interventions

Trade Name: Enterogermina® Product Name: ENTEROGERMINA Product Code: [SSR29263] Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: SPORE DI BACILLUS CLAUSII POLIANTIBIOTICO RESISTENT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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. 2. Relief of overall gastrointestinal symptoms: patient satisfaction rating of symptom improvement (satisfactory relief of overall gastrointestinal symptoms). 3. Quality of Life (QoL)questionnaire: QoL assessed by 12-Item Short Form Survey (SF-12) questionnaire. 4. Adverse Events: number of patients with adverse events.;Timepoint(s) of evaluation of this end point: 1. Up to Day 30 2. On Day 30 3. Up to Day 30 4. Up to Day 30	—

Measure

Time frame

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. 2. Relief of overall gastrointestinal symptoms: patient satisfaction rating of symptom improvement (satisfactory relief of overall gastrointestinal symptoms). 3. Quality of Life (QoL)questionnaire: QoL assessed by 12-Item Short Form Survey (SF-12) questionnaire. 4. Adverse Events: number of patients with adverse events.;Timepoint(s) of evaluation of this end point: 1. Up to Day 30 2. On Day 30 3. Up to Day 30 4. Up to Day 30

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Countries

Italy

Contacts

Public ContactCONTACT POINT

SANOFI S.p.A.

informazioni.medicoscientifiche@sanofi.com0239394168

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026