An interventional study of Yoghurt in Critical Illness and Systemic Inflammation, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Not applicable, Interventional, and Treatment
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 12 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 24 are open to participants now.
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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:
Pre-existing gastrointestinal disorders (e.g., inflammatory bowel disease, short bowel syndrome)
Severe liver disease or renal failure requiring dialysis
state (e.g., /AIDS, chemotherapy)
Participation in another interventional clinical trial within the past 30 days
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 evaluate feasibility, safety, and preliminary effects on systemic inflammation and gut microbiome composition in critically ill adults.
Dietary Supplement: Yoghurt
Participants receive standard nasogastric enteral feeding alone, without yoghurt supplementation. This control arm allows comparison of systemic inflammatory markers and gut microbiome changes relative to the yoghurt-supplemented group.
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.
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Because this is a small feasibility trial (12 participants), sharing individual participant data may not be practical or appropriate.
Ran from Jun 2021 to primary completion in Jul 2021, 1 month.
Of 400 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 1 month is below that.
Counting every sponsor, half of 404 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, Bhubaneswar