A Clinical Study to Evaluate the Effectiveness and Safety of Bacillus coagulans LBSC in Patients with Irritable Bowel Syndrome.

A Prospective, Interventional, Randomized, Double-blind and Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus coagulans LBSC in Subjects with Irritable Bowel Syndrome.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011654

Enrollment

Registered

2018-02-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Irritable Bowel Syndrome

Interventions

Intervention1: Lactic Acid Bacillus: Pharmaceutical form: Powder Dosing schedule in the study: 2 Billion colony forming unit by reconstituting in 100 ml water

twice-thrice daily prior to meal. Control Intervention1: Placebo: Pharmaceutical form: Powder Dosing schedule in the study: 2 Billion colony forming unit by reconstituting in 100 ml water

twice-thrice daily prior to meal.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and females aged 18 and 65 yrs. completed years (both inclusive) with diagnosis of IBS as per Rome IV criteria with following symptoms for more than 3 months 2. Abdominal discomfort such as mild pain, cramping, bloating, 3. Altered bowel habit indicated by frequent diarrhea or constipation 4. Functional dyspepsia 3. Written informed consent by study participants

Exclusion criteria

Exclusion criteria: 1. On antibiotics or laxatives within the preceding 6 weeks. 2. Presence of inflammatory bowel disease 3. Presence of acute GI tract infection 4. Presence of fever, abdominal mass, signs of bowel obstruction 5. History of colon cancer or diverticulitis 6. Infection by human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus 7. Patients with celiac disease defined by biopsy of the duodenal mucosa. 8. History of scleroderma and gastroparesis 9. Hypothyroidism

Design outcomes

Primary

Measure	Time frame
1. Assessment of change in Gastrointestinal symptoms frequency assessment using DSFQ on 5-point Likert scale. 2. Assessment of change in gastrointestinal symptoms severity using IBS-SSS. 3. Assessment of change in stool consistency using Bristol stool chart Timepoint: Screening to End of Treatment	—

Secondary

Measure	Time frame
Assessment of safety of investigational product: 1. Adverse event 2. Physical examination 3. Biomarker of systemic safety 4. Hematological â?? CBC 5. Hepatic - SGOT, SGPT 6. Renal - serum creatinine 7. Quality of life questionnaire by VAS assessments Timepoint: Screening to End of Treatment	—

Countries

India

Contacts

Public ContactDr Harisha s

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

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