Critical IllnessYOG-ICUNCT07812415
Yoghurt Supplementation In Critically Ill Adults
A study testing Yoghurt in people with Critical Illness and Systemic Inflammation, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Critical Illness, Systemic Inflammation
- What is being tested?
- Yoghurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences (AIIMS) Bhubaneswar
Bhubaneswar, Odisha, 751019
About this study
Official title: Feasibility and Preliminary Effects of Yoghurt Supplementation on the Gut Microbiome and Systemic Inflammation in Critically Ill Adults: A Pilot Randomized Controlled Trial
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
- Being tested
- Yoghurt
- Keywords
- Critical illness, Intensive Care Unit, Gut microbiome, Systemic Inflammation, Yoghurt supplementation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 3 days of intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 3 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Jun 2021
- Primary completion31 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Balamurugan Ramadass, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- AIIMS, Principal investigator, All India Institute of Medical Sciences (AIIMS) Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812415
- Sponsor's protocol ID
- T/IM-NF/Anaesth/19/93
- Acronym
- YOG-ICU
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because this is a small feasibility trial (12 participants), sharing individual participant data may not be practical or appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effects of Yoghurt Supplementation on the Gut Microbiome and Systemic Inflammation in Critically Ill Adults: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07812415
- Acronym / sponsor ID
- YOG-ICU / T/IM-NF/Anaesth/19/93
- Conditions
- Critical Illness, Systemic Inflammation
- Keywords
- Critical illness, Intensive Care Unit, Gut microbiome, Systemic Inflammation, Yoghurt supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Yoghurt Supplementation with Standard Feeding | Experimental | Dietary Supplement: YoghurtParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YoghurtParticipants 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. | Dietary supplement | Yoghurt Supplementation with Standard Feeding |
Primary outcome
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.
3 secondary outcomes
Change in albumin-globulin (A/G) ratio
Time frame: Baseline and after 3 days of intervention
Changes in gut microbiome composition and diversity
Time frame: Baseline and after 3 days of intervention
Microbial network connectivity and host-microbe associations
Time frame: Baseline and after 3 days of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Because this is a small feasibility trial (12 participants), sharing individual participant data may not be practical or appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AIIMS principal investigator
All India Institute of Medical Sciences (AIIMS) Bhubaneswar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoghurt in people with Critical Illness and Systemic Inflammation, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to post-intervention (time frame: Baseline and after 3 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.