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Completed

NCT Number: NCT07812415

Yoghurt Supplementation In Critically Ill Adults

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences (AIIMS) Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoghurt

Dietary 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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in albumin-globulin (A/G) ratio

    Time frame: 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.

  2. Changes in gut microbiome composition and diversity

    Time frame: 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.

  3. Microbial network connectivity and host-microbe associations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Feasibility and Preliminary Effects of Yoghurt Supplementation on the Gut Microbiome and Systemic Inflammation in Critically Ill Adults: A Pilot Randomized Controlled Trial

Acronym: YOG-ICU

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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