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To assess the efficacy of probiotic in patients with Irritable Bowel Syndrome

To Evaluate the Efficacy of Multi-Strain Probiotics (Lactogut) in Patients with Irritable Bowel Syndrome: Double Blind Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049077
Enrollment
219
Registered
2023-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: K58- Irritable bowel syndrome

Interventions

Intervention1: Lactogut (Multi-strain Probiotic) and Standard Medical Therapy: The treatment period will be for a period of 90 days. During treatment, each participant will receive Lactogut capsules o

Sponsors

Velbiom Probiotics Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed case of IBS using Rome III criteria 2. Absence of red flag signs: anemia, fever, weight loss, per rectal bleeding, nocturnal frequency, family history of IBD, cancer 3. Age 18-70 years 4. No synthetic probiotics used in prior 3 months 5. No antibiotics used in previous 2 months of enrolment

Exclusion criteria

Exclusion criteria: 1. Previous treatment with probiotics within last 3 months 2. Pregnant or lactating women 3. History of any previous surgical resection of the stomach, small intestine, or large intestine 4. Complications from infectious enteritis, hyperthyroidism, or hypothyroidism. 5. History of any diet-based intolerance (gluten or lactose intolerance). 6. History of or complications from malignant tumors. 7. Uncontrolled Type II diabetes mellitus. 8. Allergic or sensitive to probiotic products.

Design outcomes

Primary

MeasureTime frame
Assessing the effect of multi-strain probiotic on alleviating the symptoms of patients with irritable bowel syndromeTimepoint: 0,7,120,150 and 180 days

Secondary

MeasureTime frame
Monitoring the oral and gut bacteria changes in patients with irritable bowel syndrome before and after treatment with lactogut, through culture dependent, 16S gene sequence and metabolite analysesTimepoint: 0,7,120,150 and 180 days

Countries

India

Contacts

Public ContactDr Shiran Shetty

Manipal Academy of Higher Education

shiran.shetty@manipal.edu8861920517

Outcome results

None listed

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