Ileostomy - StomaEarly Phase 1NCT05759741
Alterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy
A Early Phase 1 study testing MIYAIRI 588 in people with Ileostomy - Stoma and Rectal Cancer, run by Huashan Hospital at 1 site in China.
Trial summary
This study focused on the alterations of gut microbiome and function during defunctioning ileostomy, and observed the effects of probiotic intervention on intestinal microbiome and function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ileostomy - Stoma, Rectal Cancer, Microbial Disease
- What is being tested?
- MIYAIRI 588
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2023to 17 Jul 2024
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary rectal cancer received total mesolectal resection combined with defunctioning ileostomy.
- Patients voluntarily sign informed consent.
Who cannot join
- Disease progression or death after surgery.
- Patients with inflammatory bowl disease.
- Patients need to be on antibiotics/other probiotics for a long time.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan hospital
Shanghai
Jianbin Xiang, 52887040, xjbzhw@163.com
About this study
Official title: Alterations of Gut Microbiome, Function, and Its Intervention After Total Mesorectal Excision With Defunctioning Ileostomy for Mid-low Rectal Cancer
This study focused on the alterations of gut microbiome and function during defunctioning ileostomy, and observed the effects of probiotic intervention on intestinal microbiome and function. The investigators looked forward to find the specific intestinal maladjusted flora from this work, which could provide a new scheme for the subsequent treatment of the damaged intestinal function and the reduction of the incidence of postoperative complication.
- Being tested
- MIYAIRI 588
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIYAIRI 588Drug
4 tablets of MIYAIRI 588 were inserted into the distal ileostomy once a week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| MIYAIRI 588 group | Experimental | 4 tablets of MIYAIRI 588 were inserted into distal ileostomy once a week for 6 months. Receives: Drug: MIYAIRI 588 |
| control group | No intervention | The anastomosis stoma was followed up monthly in the outpatient department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wexner incontinence score
Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence
Measured: 1 year
Secondary outcomes (2)
fecal incontinence quality-of-life scale
The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items). The score of each scale is 1-4 points. The higher the score, the worse the quality of life.
Measured: 1 year
Rate of postoperative complications
Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection，etc.
Measured: 1 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start17 Jan 2023
- Primary completion17 Jul 2024 (estimated)
- Study completion17 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group was given probiotics: 4 tablets of MIYAIRI 588, inserted into the distal ileostomy, once a week. The control group was not given drugs, only monthly outpatient follow-up of the anastomosis stoma.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianbin Xiang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759741
- Sponsor's protocol ID
- KY2022-1095
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations of Gut Microbiome, Function, and Its Intervention After Total Mesorectal Excision With Defunctioning Ileostomy for Mid-low Rectal Cancer
- ClinicalTrials.gov ID
- NCT05759741
- Acronym / sponsor ID
- KY2022-1095
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 17 Jul 2024 (estimated)
- Study completion
- 17 Jul 2024 (estimated)
- First posted
- 8 Mar 2023 (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 study focused on the alterations of gut microbiome and function during defunctioning ileostomy, and observed the effects of probiotic intervention on intestinal microbiome and function. The investigators looked forward to find the specific intestinal maladjusted flora from this work, which could provide a new scheme for the subsequent treatment of the damaged intestinal function and the reduction of the incidence of postoperative complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group was given probiotics: 4 tablets of MIYAIRI 588, inserted into the distal ileostomy, once a week. The control group was not given drugs, only monthly outpatient follow-up of the anastomosis stoma.
| Arm | Type | Receives |
|---|---|---|
| MIYAIRI 588 group | Experimental | Drug: MIYAIRI 5884 tablets of MIYAIRI 588 were inserted into distal ileostomy once a week for 6 months. |
| control group | No intervention | –The anastomosis stoma was followed up monthly in the outpatient department |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary rectal cancer received total mesolectal resection combined with defunctioning ileostomy.
- Patients voluntarily sign informed consent.
Key exclusion criteria (3 listed)
- Disease progression or death after surgery.
- Patients with inflammatory bowl disease.
- Patients need to be on antibiotics/other probiotics for a long time.
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 |
|---|---|---|
| MIYAIRI 5884 tablets of MIYAIRI 588 were inserted into the distal ileostomy once a week for 6 months | Drug | MIYAIRI 588 group |
Primary outcome
Wexner incontinence score
Time frame: 1 year
Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence
2 secondary outcomes
fecal incontinence quality-of-life scale
Time frame: 1 year
Rate of postoperative complications
Time frame: 1 month after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MIYAIRI 588 in people with Ileostomy - Stoma and Rectal Cancer, run by Huashan 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 2 inclusion and 3 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 14 Mar 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jianbin Xiang (52887040, xjbzhw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wexner incontinence score (time frame: 1 year). 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 14 Mar 2023; AzTrials last refreshed its copy on 30 Oct 2026.