Skip to content

Comparative, Randomized, Phase II Clinical Trial of in the treatment of patients with acute Diarrhea

An Open Label, III Arm, Comparative, Randomized, Phase II Clinical Trial Of Probiotic Strains Saccharomyces Boulardii, Bacillus Coagulans And Bacillus Clausii In The Treatment Of Patients With Acute Diarrhea

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000142
Enrollment
75
Registered
2010-03-17
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- Acute diarrhea Health Condition 2: R197- Diarrhea, unspecified

Interventions

Intervention1: Saccharomyces boulardii, Bacillus coagulans and Bacillus clausii: 1 Capsule two times a day before meals for 10 days Control Intervention1: Nil: Nil

Sponsors

Unique Biotech Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults with acute diarrhoea having > 3 loose stools in last 24 hours, having diarrhoea 2. Patients with no major illness. 3. Patients willing to give written informed Consent & willing to follow up.

Exclusion criteria

Exclusion criteria: 1. Mucous stools or bleeding per rectum 2. Subjects taking any other medications like anticoagulants, beta-blockers, diuretics, and steroids etc., which have potential effects on lipoprotein regulation mechanisms. 3. Subjects with the recent history of cardiovascular diseases like MI or who have undergone angioplasties, coronary bypass surgery or any other documented morbidity from atherosclerotic vascular diseases within the last 6 months of enrollment. 4. Subjects with past history of any debilitating neurological disorders, severe depression. 5. Clinical signs of severe dehydration, clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic diseases, cystic fibrosis, 6. Food allergy or other chronic gastrointestinal diseases, 7. Use of probiotics in the previous three weeks, use of antibiotics or any antidiarrhoeal medication in the previous three weeks.

Design outcomes

Primary

MeasureTime frame
1. Duration of Diarrhea 2. Frequency of Diarrhea Timepoint: 10 days

Secondary

MeasureTime frame
1. Rescue medication 2. Safety Assessment 3. Clinical Global Assessment by Investigator on liken scale 4. Patients Self Assessment Timepoint: 10 days

Countries

India

Contacts

Public ContactMr Bharat Shukla
amaurya@ihsindia.com8080838331

Outcome results

None listed

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