COVID-19NCT05970861

Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients

A study testing Freeze-dried Mare Milk (Saumal) in people with COVID-19, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: COVID-19
What is being tested?: Freeze-dried Mare Milk (Saumal)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteKazakhstan
Study dates: 1 Sep 2023to 30 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years and older;
Patients in rehabilitation after COVID-19;
Signed informed consent;
Presence of patient's history of COVID-19, reliably established by PCR+ /presence of IgG/ diagnosis of coronavirus pneumonia on Computer Tomography based on discharge from hospital or outpatient records.

Who cannot join

Chronic inflammatory bowel disease;
Gut microbiota transplantation;
Chronic pancreatic disease, period of exacerbation;
Liver cirrhosis, Metavir stage 3-4;
Any disease in the decompensation stage;
Neuralgic and psychological disorders that interfere with the study;

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Cancer;
Non-transportable patients;
Patients who do not reside in Almaty;
Patients who have refused to participate in the study.

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

Almaty House of Veterans
Almaty, 050000

Other trials in Kazakhstan

About this study

The efficacy of natural foods such as freeze-dried mare's milk (Saumal) in post-COVID syndrome therapy has not been studied. The literature review has shown that researchers have focused more on evidence-based medications and less on natural products. Some raw foods, such as freeze-dried mare's milk, contribute to forming complete immune complexes and have antioxidant, membrane stabilizing, and antiviral effects.

The use of Saumal proved its effectiveness in patients suffering from chronic hepatitis C. After 4 weeks of using freeze-dried mare's milk, the biodiversity of the intestinal microbiome was increased. The content of bacteria secreting short-chain fatty acids also increased.

The study aims to confirm these effects at the gene level in patients who underwent COVID-19. This study will allow us to develop a highly evidence-based component of rehabilitation therapy in patients after COVID-19.

Read the detailed description

The study consists of three stages. Stage I. Randomized division of 75 patients under study into a main group of 38 patients receiving Saumal for 4 weeks and a control group of 37 patients not receiving Saumal. All respondents have suffered from COVID-19 in the last 6 months. At the moment of the research, all patients will be staying in rehabilitation centers in Almaty City.

The study's biological material will be collected from the respondents (gut microbiome, antiphospholipid antibodies, biochemical blood analysis (glucose, ALT, AST, uric acid, TAGs, alkaline phosphatase)).

Stage II. The main group will be given Saumal for four weeks, after which the gut microbiome, antiphospholipid antibodies, and biochemical blood analysis will be collected from both groups again. This will allow us to assess the impact of freeze-dried mare's milk on the condition of the gut microbiome, antiphospholipid antibodies, and biochemical blood analysis.

Stage III. Data analysis.

Based on the results of gut microbiome sequencing, ELISA (antiphospholipid antibodies), and biochemical blood analysis in the main and control groups, we determine the dynamic changes of those parameters during COVID-19 rehabilitation.
According to the results, the effectiveness of Saumal itself regarding these 2 parameters will be evaluated.
Develop recommendations and an algorithm for patient management after COVID-19 to prevent complications.

Conditions: COVID-19
Being tested: Freeze-dried Mare Milk (Saumal)
Keywords: COVID-19, gut microbiome, antiphospholipid antibodies, rehabilitation, food products
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Freeze-dried Mare Milk (Saumal)Dietary supplement
Freeze-dried Mare Milk (Saumal) is frequently reported for having therapeutic and dietary properties associated with specific chemical composition and certain physical properties of the product. It contains a total of about 40 biologically active components, the most important of them vitamins A, C, B1, B2, B6, and B12, amino acids, enzymes, and trace elements (low molecular weight peptides, lactalbumins, and globulins). Saumal will be administered to patients at a dose of 25 grams of dry powder per 200 ml of water, 2 times a day, 30 minutes before the meal, for 4 weeks.

Study groups in NCT05970861
Study group	Role	What they receive
Main Group	Experimental	Patients who had suffered from COVID-19 in the six months before the start of the study. Patients will receive Saumal (freeze-dried mare milk) for four weeks. Receives: Dietary Supplement: Freeze-dried Mare Milk (Saumal)
Control Group	No intervention	Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Gut Microbiome
Intestinal microbiome studies will be performed using the Illumina MiSeq Metagenomics Kit. Creation of libraries for NGS sequencing. The commercial Illumina MiSeq The Metagenomics Kit includes two primer pools that can amplify the hypervariable regions of 16S rRNA in bacteria. The first pool produces V2-4-8, while the second pool allows for the production of V3-6 and 7-9 regions of 16S rRNA. Sequencing will be performed on an Ion S5 analyzer using an Illumina MiSeq Chip Kit. Once the PCR products have been run, it is important to follow standard procedures for fragment end recovery, adaptor ligation, nick gap repair, qualitative and quantitative assessment of non-amplified libraries, and pooling.
Measured: 4 weeks
Antiphospholipid Antibodies
IgG or IgM autoantibodies to cardiolipin, phosphatidyl serine, phosphatidyl-inositol, phosphatidyl acid, and β2-glycoprotein I are determined in human venous blood serum by enzyme immunoassay (ELISA) using the Anti-Phospholipid Screen IgG/IgM kit.
Measured: 4 weeks
Biochemical Blood Analysis (Uric Acid)
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
Measured: 4 weeks
Quality of Life Changes
Constructs: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), Mental Health (MH). All scale ranges (for any construct): 0 to 100.
Higher scores indicate: PF - better physical functioning; RP - fewer role limitations due to physical health; BP - less bodily pain; GH - better perceived general health; VT - greater vitality and less fatigue; SF - better social functioning; RE - fewer role limitations due to emotional problems; MH - better mental health.
The SF-36 does not have a single total score but can be summarized using two summary measures:
1. Physical Component Summary (PCS). Combines the following scales: PF, RP, BP, GH.
2. Mental Component Summary (MCS). Combines the following scales: VT, SF, RE, MH. Higher scores indicate better physical and mental health. Range: Typically standardized (mean = 50, SD = 10)
Measured: 4 weeks

Secondary outcomes (5)

Biochemical Blood Analysis (ALT)
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
Measured: 4 weeks
Biochemical Blood Analysis (AST)
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
Measured: 4 weeks
Biochemical Blood Analysis (Glucose)
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
Measured: 4 weeks
Biochemical Blood Analysis (Triacylglycerides)
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
Measured: 4 weeks
Biochemical Blood Analysis (Alkaline Phosphatase)
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202330 Aug 2024

First posted1 Aug 2023
Study start1 Sep 2023
Primary completion30 Aug 2024
Study completion30 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05970861
Sponsor's protocol ID: KazNMU_Saumal_COVID
Status last verified: Jan 2025
First submitted: 31 Jul 2023
Last updated: 5 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zuo T, Zhang F, Lui GCY, Yeoh YK, Li AYL, Zhan H, Wan Y, Chung ACK, Cheung CP, Chen N, Lai CKC, Chen Z, Tso EYK, Fung KSC, Chan V, Ling L, Joynt G, Hui DSC, Chan FKL, Chan PKS, Ng SC. Alterations in Gut Microbiota of Patients With COVID-19 During Time of Hospitalization. Gastroenterology. 2020 Sep;159(3):944-955.e8. doi: 10.1053/j.gastro.2020.05.048. Epub 2020 May 20.
PubMed 32442562
Yeoh YK, Zuo T, Lui GC, Zhang F, Liu Q, Li AY, Chung AC, Cheung CP, Tso EY, Fung KS, Chan V, Ling L, Joynt G, Hui DS, Chow KM, Ng SSS, Li TC, Ng RW, Yip TC, Wong GL, Chan FK, Wong CK, Chan PK, Ng SC. Gut microbiota composition reflects disease severity and dysfunctional immune responses in patients with COVID-19. Gut. 2021 Apr;70(4):698-706. doi: 10.1136/gutjnl-2020-323020. Epub 2021 Jan 11.
PubMed 33431578
Romaniuk K., Majszyk-Świątek M., Kryszak K., Danielewicz A., Andraszek K. Alternative use of mare milk. Folia Pomer. Univ. Technol. Stetin. 2019;348:121-130. doi: 10.21005/AAPZ2019.49.1.13.
Kushugulova A., Kozhakhmetov S., Sattybayeva R., Nurgozhina A., Ziyat A., Yadav H., Marotta F. Mare's milk as a prospective functional product. Funct. Food Health Dis. 2018;8:537-543. doi: 10.31989/ffhd.v8i11.528.
Musayev, A., Yeshmanova, A., Pakhomenko, Y., Kozhakhmetov, S.S., Kushugulova, A.K. Effects of Environmental Pollutants on Intestinal Microbiome Under the Influence Of Mare's Milk In Patients with Hepatitis C. Procedia Environmental Science, Engineering and Management 2020;7(4):605-611.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients
ClinicalTrials.gov ID: NCT05970861
Acronym / sponsor ID: KazNMU_Saumal_COVID
Conditions: COVID-19
Keywords: COVID-19, gut microbiome, antiphospholipid antibodies, rehabilitation, food products
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 1 Aug 2023 (actual)
Results: Posted 5 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Stage III. Data analysis.

Based on the results of gut microbiome sequencing, ELISA (antiphospholipid antibodies), and biochemical blood analysis in the main and control groups, we determine the dynamic changes of those parameters during COVID-19 rehabilitation.
According to the results, the effectiveness of Saumal itself regarding these 2 parameters will be evaluated.
Develop recommendations and an algorithm for patient management after COVID-19 to prevent complications.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Main Group	Experimental	Dietary Supplement: Freeze-dried Mare Milk (Saumal)Patients who had suffered from COVID-19 in the six months before the start of the study. Patients will receive Saumal (freeze-dried mare milk) for four weeks.
Control Group	No intervention	–Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 years and older;
Patients in rehabilitation after COVID-19;
Signed informed consent;
Presence of patient's history of COVID-19, reliably established by PCR+ /presence of IgG/ diagnosis of coronavirus pneumonia on Computer Tomography based on discharge from hospital or outpatient records.

Key exclusion criteria (10 listed)

Chronic inflammatory bowel disease;
Gut microbiota transplantation;
Chronic pancreatic disease, period of exacerbation;
Liver cirrhosis, Metavir stage 3-4;
Any disease in the decompensation stage;

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
Freeze-dried Mare Milk (Saumal)Freeze-dried Mare Milk (Saumal) is frequently reported for having therapeutic and dietary properties associated with specific chemical composition and certain physical properties of the product. It contains a total of about 40 biologically active components, the most important of them vitamins A, C, B1, B2, B6, and B12, amino acids, enzymes, and trace elements (low molecular weight peptides, lactalbumins, and globulins). Saumal will be administered to patients at a dose of 25 grams of dry powder per 200 ml of water, 2 times a day, 30 minutes before the meal, for 4 weeks.	Dietary supplement	Main Group

Primary outcome

Gut Microbiome
Time frame: 4 weeks
Intestinal microbiome studies will be performed using the Illumina MiSeq Metagenomics Kit. Creation of libraries for NGS sequencing. The commercial Illumina MiSeq The Metagenomics Kit includes two primer pools that can amplify the hypervariable regions of 16S rRNA in bacteria. The first pool produces V2-4-8, while the second pool allows for the production of V3-6 and 7-9 regions of 16S rRNA. Sequencing will be performed on an Ion S5 analyzer using an Illumina MiSeq Chip Kit. Once the PCR products have been run, it is important to follow standard procedures for fragment end recovery, adaptor ligation, nick gap repair, qualitative and quantitative assessment of non-amplified libraries, and pooling.
Antiphospholipid Antibodies
Time frame: 4 weeks
IgG or IgM autoantibodies to cardiolipin, phosphatidyl serine, phosphatidyl-inositol, phosphatidyl acid, and β2-glycoprotein I are determined in human venous blood serum by enzyme immunoassay (ELISA) using the Anti-Phospholipid Screen IgG/IgM kit.
Biochemical Blood Analysis (Uric Acid)
Time frame: 4 weeks
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
Quality of Life Changes
Time frame: 4 weeks
Constructs: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), Mental Health (MH). All scale ranges (for any construct): 0 to 100. Higher scores indicate: PF - better physical functioning; RP - fewer role limitations due to physical health; BP - less bodily pain; GH - better perceived general health; VT - greater vitality and less fatigue; SF - better social functioning; RE - fewer role limitations due to emotional problems; MH - better mental health. The SF-36 does not have a single total score but can be summarized using two summary measures: 1. Physical Component Summary (PCS). Combines the following scales: PF, RP, BP, GH. 2. Mental Component Summary (MCS). Combines the following scales: VT, SF, RE, MH. Higher scores indicate better physical and mental health. Range: Typically standardized (mean = 50, SD = 10)

5 secondary outcomes

Biochemical Blood Analysis (ALT)
Time frame: 4 weeks
Biochemical Blood Analysis (AST)
Time frame: 4 weeks
Biochemical Blood Analysis (Glucose)
Time frame: 4 weeks
Biochemical Blood Analysis (Triacylglycerides)
Time frame: 4 weeks
Biochemical Blood Analysis (Alkaline Phosphatase)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 5 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main Group	38	30
Control Group	37	30

Primary outcome: Gut Microbiome

Time frame: 4 weeks. Mean (Standard Error). Unit: Mean percentages of gut microbiota units

Measure	Main Group n = 30	Control Group n = 30
Percentage of "Firmicutes" phylum at 4 weeks	51.87 (0.001)	46.1 (0.899)
Percentage of "Bacteroides" phylum at 4 weeks	29.43 (0.178)	29.77 (0.754)
Percentage of "Proteobacteria" phylum at 4 weeks	6.52 (0.00001)	7.91 (0.823)
Percentage of "Actinobacteria" phylum at 4 weeks	4.9 (0.951)	9.36 (0.003)
Percentage of "Bacilli" class at 4 weeks	4.02 (0.043)	4.46 (0.068)
Percentage of "Deltaproteobacteria" class at 4 weeks	0.94 (0.048)	0.92 (0.918)
Percentage of "Erysipelotrichi" class at 4 weeks	1.58 (0.012)	1.46 (0.889)
Percentage of "Caldilinea" genus at 4 weeks	0.06 (0.014)	0.17 (0.345)

Main Group vs Control Group: p <0.05, t-test, 2 sided
Main Group vs Control Group: p <0.05, ANOVA

Primary outcome: Antiphospholipid Antibodies

Time frame: 4 weeks. Mean (Standard Error). Unit: U/ml

Measure	Main Group n = 30	Control Group n = 30
IgM	2.73 (0.185)	4.45 (0.001)
IgG	1.43 (0.726)	4.50 (0.0001)

Main Group vs Control Group: p >0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Biochemical Blood Analysis (Uric Acid)

Time frame: 4 weeks. Mean (Standard Error). Unit: mg/dL

Measure	Main Group n = 30	Control Group n = 30
Value	5.56 (0.01)	7.87 (0.34)

Main Group vs Control Group: p = 0.01, Wilcoxon (Mann-Whitney)

Primary outcome: Quality of Life Changes

Time frame: 4 weeks. Mean (Standard Error). Unit: T-score

Measure	Main Group n = 30	Control Group n = 30
PCS	47.965 (0.004)	50.797 (0.647)
MCS	49.524 (0.001)	49.393 (0.091)

Main Group: p <0.01, t-test, 2 sided
Control Group: p >0.05, t-test, 2 sided
Main Group vs Control Group: p <0.01, ANOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Any adverse events have not been monitored or evaluated.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Group	0 of 0	0 of 0	0
Control Group	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): There were three main limitations to the study: 1. A significant amount of time has passed since the patients had COVID-19. 2. During the analysis of antiphospholipid antibody levels, we found that screening kits were used. 3. The severity of COVID-19 was not considered as an inclusion criterion.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32442562Zuo T, Zhang F, Lui GCY, Yeoh YK, Li AYL, Zhan H, Wan Y, Chung ACK, Cheung CP, Chen N, Lai CKC, Chen Z, Tso EYK, Fung KSC, Chan V, Ling L, Joynt G, Hui DSC, Chan FKL, Chan PKS, Ng SC. Alterations in Gut Microbiota of Patients With COVID-19 During Time of Hospitalization. Gastroenterology. 2020 Sep;159(3):944-955.e8. doi: 10.1053/j.gastro.2020.05.048. Epub 2020 May 20.
Background: PubMed 33431578Yeoh YK, Zuo T, Lui GC, Zhang F, Liu Q, Li AY, Chung AC, Cheung CP, Tso EY, Fung KS, Chan V, Ling L, Joynt G, Hui DS, Chow KM, Ng SSS, Li TC, Ng RW, Yip TC, Wong GL, Chan FK, Wong CK, Chan PK, Ng SC. Gut microbiota composition reflects disease severity and dysfunctional immune responses in patients with COVID-19. Gut. 2021 Apr;70(4):698-706. doi: 10.1136/gutjnl-2020-323020. Epub 2021 Jan 11.
BackgroundRomaniuk K., Majszyk-Świątek M., Kryszak K., Danielewicz A., Andraszek K. Alternative use of mare milk. Folia Pomer. Univ. Technol. Stetin. 2019;348:121-130. doi: 10.21005/AAPZ2019.49.1.13.
BackgroundKushugulova A., Kozhakhmetov S., Sattybayeva R., Nurgozhina A., Ziyat A., Yadav H., Marotta F. Mare's milk as a prospective functional product. Funct. Food Health Dis. 2018;8:537-543. doi: 10.31989/ffhd.v8i11.528.
BackgroundMusayev, A., Yeshmanova, A., Pakhomenko, Y., Kozhakhmetov, S.S., Kushugulova, A.K. Effects of Environmental Pollutants on Intestinal Microbiome Under the Influence Of Mare's Milk In Patients with Hepatitis C. Procedia Environmental Science, Engineering and Management 2020;7(4):605-611.

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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.

Ainur Yeshmanova, Ph.D. study director

Asfendiyarov Kazakh National Medical University

Nikolay Safonov study chair

Asfendiyarov Kazakh National Medical University

Zhannat Nurmakhanova, Ph.D study chair

Asfendiyarov Kazakh National Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Freeze-dried Mare Milk (Saumal) in people with COVID-19, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.

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 10 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 5 Feb 2025. 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 Kazakhstan. 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?

Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Gut Microbiome (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05970861, which also lists 5 linked publications.

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 5 Feb 2025.