Critical Illness, Systemic Inflammation
Conditions
Keywords
Critical illness, Intensive Care Unit, Gut microbiome, Systemic Inflammation, Yoghurt supplementation
Brief summary
This pilot randomized controlled trial tested the feasibility of yoghurt supplementation (400 mL/day for 3 days) in critically ill adults receiving nasogastric feeds. Twelve patients were enrolled, with high adherence and no safety concerns reported. Yoghurt intake was associated with a significant reduction in systemic inflammation markers, particularly the neutrophil-to-lymphocyte ratio (NLR), and modest shifts in gut microbiome composition. Beneficial commensals such as Lactiplantibacillus plantarum and Bifidobacterium adolescentis were enriched, while opportunistic pathogens like Klebsiella pneumoniae and Clostridioides difficile were depleted. Microbial network analysis revealed increased connectivity and stability in the yoghurt group. Overall, yoghurt supplementation was feasible, safe, and showed preliminary biological signals of modulating inflammation and microbial ecology, supporting the rationale for a larger multicentre trial.
Interventions
DIETARY_SUPPLEMENTYoghurt
Participants receive standard nasogastric enteral feeding supplemented with 400 mL/day of plain yoghurt (OMFED, Bhubaneswar, India) administered once daily for three consecutive days. The intervention is designed to assess feasibility, safety, and preliminary effects on systemic inflammation and gut microbiome composition in critically ill adults.
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This was a single-centre, double-blind, randomized controlled pilot trial with two parallel arms. Critically ill adults receiving nasogastric feeds were assigned to either standard feeding plus yoghurt supplementation (400 mL/day for 3 days) or standard feeding alone. Randomization was computer-generated, and blinding was maintained for participants, investigators, and laboratory staff.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years Admitted to Intensive Care Unit (ICU) with critical illness requiring nasogastric feeding Expected to remain in ICU for at least 3 days Able to receive enteral nutrition via nasogastric tube
Exclusion criteria
* Known allergy or intolerance to dairy products Pre-existing gastrointestinal disorders (e.g., inflammatory bowel disease, short bowel syndrome) Severe liver disease or renal failure requiring dialysis Immunocompromised state (e.g., HIV/AIDS, chemotherapy) Participation in another interventional clinical trial within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to post-intervention | Baseline and after 3 days of intervention | NLR is a widely used marker of systemic inflammation in critically ill patients. The primary outcome is the change in NLR between baseline and post-intervention in the yoghurt-supplemented group compared with the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in albumin-globulin (A/G) ratio | Baseline and after 3 days of intervention | The A/G ratio reflects systemic inflammatory and immune status. The secondary outcome is the change in A/G ratio between baseline and post-intervention. |
| Changes in gut microbiome composition and diversity | Baseline and after 3 days of intervention | Stool samples undergo 16S rRNA sequencing to assess shifts in microbial diversity, enrichment of beneficial taxa, and depletion of opportunistic pathogens. |
| Microbial network connectivity and host-microbe associations | Baseline and after 3 days of intervention | Co-occurrence and correlation network analyses are performed to evaluate changes in microbial community structure and associations with systemic inflammation markers. |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORAIIMS
All India Institute of Medical Sciences (AIIMS) Bhubaneswar
Outcome results
None listed