Inflammatory Bowel DiseaseNCT06781827
Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease
A study testing Probiotic in people with Inflammatory Bowel Disease, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
This study evaluates oral Lactobacillus reuteri as an adjunct therapy for 2 months. Endoscopic assessments will be performed at baseline and after 2 months of intervention to evaluate intestinal inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2025to 30 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be over 18 years old
- Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -
Who cannot join
- Does not meet the diagnostic criteria of CD
- Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc
- Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness
- Patients with suspected cancer in their intestines
- Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery)
- There is currently an infection
- He has had cancer in the last 5 years -
Trial locations and contacts
1 site in 1 country.
China1 site
Gastroenterology Department of Jiangsu Province （Suqian）Hospital
Suqian, Jiangsu, 223800
About this study
Official title: Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel
This study evaluates oral Lactobacillus reuteri as an adjunct therapy for 2 months. Endoscopic assessments will be performed at baseline and after 2 months of intervention to evaluate intestinal inflammation. Intestinal fluid samples will be collected during endoscopy for 16S rRNA gene sequencing to assess changes in the gut microbiota. Peripheral blood inflammatory markers and fecal calprotectin levels will also be measured to evaluate changes in intestinal inflammation.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Probiotic
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The experimental phase of the study lasts 8 weeks and each patient will be visited 4 times.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Daily intervention with Limosilactobacillus reuteri LR08 (10 billion CFU) for 8 weeks, stored in a cool and dry place. Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intestinal Inflammation
Intestinal inflammation will be assessed using the Simple Endoscopic Score for Crohn's Disease (SES-CD) in patients with Crohn's disease and the Mayo Score in patients with ulcerative colitis. SES-CD scores range from 0 to 56, and Mayo scores range from 0 to 12. Higher scores indicate more severe disease activity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start25 Jan 2025
- Primary completion30 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781827
- Sponsor's protocol ID
- WK20250106
- Status last verified
- Oct 2026
- First submitted
- 10 Jan 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel
- ClinicalTrials.gov ID
- NCT06781827
- Acronym / sponsor ID
- WK20250106
- Conditions
- Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Jan 2025 (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 evaluates oral Lactobacillus reuteri as an adjunct therapy for 2 months. Endoscopic assessments will be performed at baseline and after 2 months of intervention to evaluate intestinal inflammation. Intestinal fluid samples will be collected during endoscopy for 16S rRNA gene sequencing to assess changes in the gut microbiota. Peripheral blood inflammatory markers and fecal calprotectin levels will also be measured to evaluate changes in intestinal inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticDaily intervention with Limosilactobacillus reuteri LR08 (10 billion CFU) for 8 weeks, stored in a cool and dry place. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be over 18 years old
- Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -
Key exclusion criteria (7 listed)
- Does not meet the diagnostic criteria of CD
- Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc
- Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness
- Patients with suspected cancer in their intestines
- Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery)
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 |
|---|---|---|
| ProbioticThe experimental phase of the study lasts 8 weeks and each patient will be visited 4 times. | Dietary supplement | Probiotic |
Primary outcome
Change in Intestinal Inflammation
Time frame: 8 weeks
Intestinal inflammation will be assessed using the Simple Endoscopic Score for Crohn's Disease (SES-CD) in patients with Crohn's disease and the Mayo Score in patients with ulcerative colitis. SES-CD scores range from 0 to 56, and Mayo scores range from 0 to 12. Higher scores indicate more severe disease activity.
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 28 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Inflammatory Bowel Disease, run by Wecare Probiotics Co., Ltd. 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 7 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 28 Oct 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 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.
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 Intestinal Inflammation (time frame: 8 weeks). 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 28 Oct 2026.