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Studying effects of probiotic preparation on old people with lung infection

Exploring effects of probiotic formulation (resB® Lung Support) on gut-lung axis in elderly pneumonia patients: an RCT

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041687
Enrollment
60
Registered
2022-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Health Condition 1: J189- Pneumonia, unspecified organism

Interventions

Intervention1: resB® Lung Support: Receiving resB® Lung Support capsule twice daily orally for 14 days from enrolment Control Intervention1: Placebo: Receiving placebo capsules twice daily for 14 da

Sponsors

ResBiotic Nutrition
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Elderly patients (age > 60 years) admitted to the various ICUs / Emergency Department of AIIMS, Bhubaneswar who provide a valid informed consent for participation in the trial

Exclusion criteria

Exclusion criteria: 1. Any contraindications for enteral feeding during the proposed study period 2. Any contraindications for broncho-alveolar lavage 3. Patients with intestinal diversions and stoma and diagnosed anatomical abnormalities of the GI tract like muco-cutaneous fistulae, etc. 4. Patients with hematological malignancies, infected with hemo-parasites or lymphotropic organisms. 5. Patients with chest trauma.

Design outcomes

Primary

MeasureTime frame
Incidence and Prognosis in elderly pneumonia admitted to acute care set-up with and without resB® Lung SupportTimepoint: A longitudinal assessment of incidence during the entire duration of the study Prognosis will be assessed upto 30 days of recruitment

Secondary

MeasureTime frame
Characterizing the microbial composition in the broncho- pulmonary aspirates Timepoint: â?¢ Within 24 hours of admission and enrolment â?¢ After 14 completed days of interventional supplementation â?¢ After 30 completed days since initiation of interventional supplementation/ hospital discharge â?? whichever is earlier;Evaluating any change in the gut microbial composition from stool sample analysis Timepoint: â?¢ Within 24 hours of admission and enrolment â?¢ After 14 completed days of interventional supplementation â?¢ After 30 completed days since initiation of interventional supplementation/ hospital discharge â?? whichever is earlier;Measuring the levels of total small chain fatty acids in the stool sampleTimepoint: â?¢ Within 24 hours of admission and enrolment â?¢ After 14 completed days of interventional supplementation â?¢ After 30 completed days since initiation of interventional supplementation/ hospital discharge â?? whichever is earlier;Measuring the secretory IgA levels in the bronchopulmonary secretions and blood samples Timepoint: â?¢ Within 24 hours of admission and enrolment â?¢ After 14 completed days of interventional supplementation â?¢ After 30 completed days since initiation of interventional supplementation/ hospital discharge â?? whichever is earlier

Countries

India

Contacts

Public ContactDr Jayanta Kumar Mitra

AIIMS-Bhubaneswar

mitra.jayanta@gmail.com9433798583

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 12, 2026