Yoghurt Supplementation In Critically Ill Adults

NCT07812415 | Completed

• 1 other identifier: T/IM-NF/Anaesth/19/93
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Systemic Inflammation

Keywords

Critical illness; Intensive Care Unit; Gut microbiome; Systemic Inflammation; Yoghurt supplementation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 3 days of intervention

Secondary Outcomes (3)

• Change in albumin-globulin (A/G) ratio

  Baseline and after 3 days of intervention

• Changes in gut microbiome composition and diversity

  Baseline and after 3 days of intervention

• Microbial network connectivity and host-microbe associations

  Baseline and after 3 days of intervention

Study Arms (2)

Yoghurt Supplementation with Standard Feeding

EXPERIMENTAL

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

Standard Feeding without Yoghurt

NO INTERVENTION

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.

Interventions

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.

Yoghurt Supplementation with Standard Feeding

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences (AIIMS) Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• AIIMS

  All India Institute of Medical Sciences (AIIMS) Bhubaneswar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor, Department of Biochemistry Faculty-in-Charge, Center of Excellence for Clinical Microbiome Research Faculty-in-Charge

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 10, 2026
• Study Start: June 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: August 1, 2021
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)