Gut MicrobiotaNCT05392348
Human Gut Microbiota and microRNA Expression
A study testing stachyose and Maltodextrin in people with Gut Microbiota and microRNA, run by Xijing Hospital at 1 site in China.
Trial summary
In this study, stachyose was used as an intervention factor. We will evaluate changes in fecal gut microbiota and miRNA expression profiles in subjects under stachyose intervention Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, microRNA
- What is being tested?
- stachyose and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to 30 Jun 2022
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy human
Who cannot join
- people who need intake antibiotics，probiotics or its product
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliate Hospital of the Air Force Medical University
Xi'an, Shaanxi, 710062
Ting Li, PhD, 15891720780, tingli@snnu.edu.cn
About this study
Official title: Regulatory Effect of Stachyose on Gut Microbiota and microRNA Expression in Human
In this study, stachyose was used as an intervention factor. We will evaluate changes in fecal gut microbiota and miRNA expression profiles in subjects under stachyose intervention
Read the detailed description
In the stachyose intervention group, each person in the stachyose intervention group took 5 g of stachyose daily before breakfast, and the administration method was 100 ml of drinking water dissolved and taken orally for two months. Each person in the placebo control group took the same amount of maltodextrin daily. Stool samples of the subjects were collected weekly.
- Conditions
- Gut Microbiota, microRNA
- Being tested
- stachyose, Maltodextrin
- Keywords
- stachyose, gut microbiota, microRNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stachyoseDietary supplement
Stachyose is a tetrasaccharide consisting of sucrose having an alpha-D-galactosyl-(1->6)-alpha-D-galactosyl moiety attached at the 6-position of the glucose.
MaltodextrinDietary supplement
Maltodextrin is a polysaccharide that is used primarily in foods and beverages as a thickener, sweetener, and/or stabilizer. It is a relatively short-chain polymer (some would call it an oligomer); commercial products contain an average of ≈3 to ≈17 glucose units per chain. It is manufactured by partially hydrolyzing grain starches, usually corn or wheat.
| Study group | Role | What they receive |
|---|---|---|
| Normal Control group | Placebo comparator | Subjects with maltodextrin as intervention，5g/kg·bw/day. Receives: Dietary Supplement: Maltodextrin |
| Stachyose intervention group | Experimental | Subjects with stachyose as intervention，5g/kg·bw/day. Receives: Dietary Supplement: stachyose |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of microRNA
small rna sequencing valuated the microRNA expression in human
Measured: up to 4 weeks
structure of gut microbiota
16S rDNA sequencing valuated the gut microbiota composition in human
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start25 May 2022 (estimated)
- Primary completion25 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Guo, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392348
- Sponsor's protocol ID
- KY20212094-C-1
- Status last verified
- Jun 2021
- First submitted
- 7 Jul 2021
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Effect of Stachyose on Gut Microbiota and microRNA Expression in Human
- ClinicalTrials.gov ID
- NCT05392348
- Acronym / sponsor ID
- KY20212094-C-1
- Conditions
- Gut Microbiota, microRNA
- Keywords
- stachyose, gut microbiota, microRNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 26 May 2022 (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.
In this study, stachyose was used as an intervention factor. We will evaluate changes in fecal gut microbiota and miRNA expression profiles in subjects under stachyose intervention
Detailed description
In the stachyose intervention group, each person in the stachyose intervention group took 5 g of stachyose daily before breakfast, and the administration method was 100 ml of drinking water dissolved and taken orally for two months. Each person in the placebo control group took the same amount of maltodextrin daily. Stool samples of the subjects were collected weekly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Control group | Placebo comparator | Dietary Supplement: MaltodextrinSubjects with maltodextrin as intervention，5g/kg·bw/day. |
| Stachyose intervention group | Experimental | Dietary Supplement: stachyoseSubjects with stachyose as intervention，5g/kg·bw/day. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy human
Key exclusion criteria (1 listed)
- people who need intake antibiotics，probiotics or its product
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 |
|---|---|---|
| stachyoseStachyose is a tetrasaccharide consisting of sucrose having an alpha-D-galactosyl-(1->6)-alpha-D-galactosyl moiety attached at the 6-position of the glucose. | Dietary supplement | Stachyose intervention group |
| MaltodextrinMaltodextrin is a polysaccharide that is used primarily in foods and beverages as a thickener, sweetener, and/or stabilizer. It is a relatively short-chain polymer (some would call it an oligomer); commercial products contain an average of ≈3 to ≈17 glucose units per chain. It is manufactured by partially hydrolyzing grain starches, usually corn or wheat. | Dietary supplement | Normal Control group |
Primary outcome
expression of microRNA
Time frame: up to 4 weeks
small rna sequencing valuated the microRNA expression in human
structure of gut microbiota
Time frame: up to 4 weeks
16S rDNA sequencing valuated the gut microbiota composition in human
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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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.
Chao Guo study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stachyose and Maltodextrin in people with Gut Microbiota and microRNA, run by Xijing Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 May 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Guo (029-84775475 ext. 8203, xysn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression of microRNA (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. 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 26 May 2022.