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To compare the Efficacy of Postbiotic Trybutyrin, probiotics, and Pre/Pro/Postbiotic fixed dose combination in Adults With Functional Gastrointestinal Disorders

A Randomized, Double-Blind, Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Nutraceutical Formulations Containing Postbiotic Trybutyrin, Probiotics, And A Pre/Pro/Postbiotic Combination In Adults With Functional Gastrointestinal Disorders. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094597
Enrollment
30
Registered
2025-09-11
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: K219- Gastro-esophageal reflux disease without esophagitis

Interventions

Intervention1: Trybutyrin: 500mg capsule, oral once daily Control Intervention1: combination of prebiotics, probiotics, and postbiotic Trybutyrin.: 500mg capsule, oral once daily

Sponsors

Aeon Formulations Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 65 years. 2. Subjects with Rome IV criteria-based diagnosis of IBS, OR Individuals with functional gastrointestinal symptoms (e.g., bloating, mild abdominal pain, altered bowel habits) but no serious underlying disease. 3. Stable clinical condition without acute illnesses. 4. Willing and able to provide written informed consent. 5. Capable of understanding and adhering to the protocol, including completion of the symptom diaries and follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Recent use of related interventions: Use of antibiotics, probiotics, prebiotics, or postbiotics within 4 weeks prior to screening. 2. Gastrointestinal comorbidities: History or presence of inflammatory bowel disease, celiac disease, gastrointestinal malignancies, GI surgeries (except appendectomy or hernia repair), or severe dysbiosis. 3. Chronic conditions: Poorly controlled diabetes, renal, hepatic, or cardiovascular diseases. 4. Immunocompromised status: Including HIV, cancer chemotherapy, or immunosuppressive therapy. 5. Pregnancy and lactation. 6. Known allergy or hypersensitivity to any component of the investigational products. 7. Participation in another clinical trial within the past 30 days. 8. Substance abuse or alcoholism history that may interfere with compliance or safety. 9. Psychiatric or cognitive disorders that may affect compliance or accurate symptom reporting.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of Postbiotic Trybutyrin, probiotics, and Pre/Pro/Postbiotic FDC.Timepoint: Day 1, 15, 30, 45, and 59—

Secondary

MeasureTime frame
To assess the safety and tolerability of all interventions. To explore mechanisms of actionTimepoint: Day 1, 15, 30, 45, and 59—

Countries

India

Contacts

Public ContactDr Jothi Shankar

Srinivasan Rajalakshmi Memorial Hospital (SRMH)

srmhresearch@gmail.com9941208262

Outcome results

None listed

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