Yoghurt Supplementation In Critically Ill Adults

All India Institute of Medical Sciences, Bhubaneswar12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Critical Illness Systemic Inflammation

Interventions

YoghurtDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to post-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.

Time frame: Baseline and after 3 days of intervention

Secondary Outcomes

Change in albumin-globulin (A/G) ratio

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.

Time frame: Baseline and after 3 days of intervention

Changes in gut microbiome composition and diversity

Stool samples undergo 16S rRNA sequencing to assess shifts in microbial diversity, enrichment of beneficial taxa, and depletion of opportunistic pathogens.

Time frame: Baseline and after 3 days of intervention

Microbial network connectivity and host-microbe associations

Co-occurrence and correlation network analyses are performed to evaluate changes in microbial community structure and associations with systemic inflammation markers.

Time frame: Baseline and after 3 days of intervention

Yoghurt Supplementation In Critically Ill Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes