Evaluation of probiotic bacillus clausii strain in patients with IBS.

A randomized,double blind, placebo controlled,parallel,multicenter, phase 3 study on genetic and clinical evaluation of probiotic bacillus clausii strain in patients with irritable bowel syndrome. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064090

Enrollment

Registered

2024-03-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: K582- Mixed irritable bowel syndrome

Interventions

Intervention1: Probiotic-Bacillus Clausii Strain: Dose:Take one capsules or as directed, best taken prior to a meal. Frequency:One Capsule or as directed Route of Administration: Oral Total Duration o

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e [Recurrent abdominal pain (on average, at least 1 day or week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool)]. 2.Patients willing to provide written informed consent and comply to protocol requirements.

Exclusion criteria

Exclusion criteria: 1.Any patient with weight or appetite loss, iron deficiency anemia, fever or rectal bleeding 2.Known inflammatory bowel disease or celiac disease patients, 3.Immuno-compromised patients 4.Pregnancy or wishing to become pregnant during the study 5.End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases greater tyhan 3.5x above normal) 6.The use of other probiotic products or antibiotics over the previous 6 months 7.Participation in other clinical trials 8.The presence of other medical conditions that in the opinion of the investigators could jeopardize compliance with the protocol (e.g., malabsorption syndrome or an inability to take orally administered medications)

Design outcomes

Primary

Measure	Time frame
Global response to treatment for the target lesion based on IBS severity (IBS-SSS), The maximum achievable score was 500 and cases were indicated by scores of Mild: - 75 to 175 Moderate: - 175 to 300 Severe: - Greater than 300 Timepoint: ?Baseline (Day 01) ?Visit 02 (Day 45): Interim visit ?Visit 03 (Day 90): End of Study	—

Secondary

Measure	Time frame
To assess the safety and tolerability of Probiotic?Bacillus Clausii Strain in patients with irritable bowel syndrome.Timepoint: ?Baseline (Day 01) ?Visit 02 (Day 45): Interim visit ?Visit 03 (Day 90): End of Study	—

Countries

India

Contacts

Public ContactDr Suman G

Ralakshmi Hospital

drsumanpi2022@gmail.com9986046906

Outcome results

None listed

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