- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05652621
Efficacy of Probiotics in Patients With IBD
December 7, 2022 updated by: The First Affiliated Hospital of Xinxiang Medical College
Clinical Efficacy and Mechanism of Probiotics in the Adjuvant Treatment of Ulcerative Colitis and Irritable Bowel Syndrome
This research group plans to take patients with mild to moderate UC and diarrhea IBS diagnosed in the First Affiliated Hospital of Xinxiang Medical College as examples, and divide them into UC group and IBS group; Each group was randomly divided into two groups, namely, conventional treatment+probiotics group and conventional treatment+probiotics placebo group.Starting from the intervention of probiotics on intestinal flora to alleviate intestinal injury caused by UC and IBS patients, the indicators of intestinal flora, serum inflammatory factors, metabolites in vivo, intestinal barrier-related protein expression, and fecal short-chain fatty acid level were detected to explore the clinical efficacy, intestinal protective effect and mechanism of probiotics in adjuvant treatment of UC and IBS patients.To provide new methods and new ideas for refractory UC and IBS, so as to improve the cure rate of UC and IBS, reduce the recurrence rate, relieve the physical and mental pain and economic burden of patients, and provide new ideas for the development and utilization of functional probiotics.
It also seeks biosafety evidence for the future use of probiotics in antibiotic environment.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Some studies suggest that IBS is related to UC, and it is speculated that IBS may be a mild UC.
Some researchers have also reported that more and more UC patients have irritable bowel syndrome-like symptoms unrelated to intestinal inflammatory activities in remission.At present, it is generally believed that the imbalance of intestinal flora is the main cause of UC and IBS.
At present, antibiotics are still the main drugs to treat this disease.Antibiotic treatment often destroys the intestinal microecology, which makes the intestinal microecology unbalanced.
Therefore, it is of great guiding significance to find a safe and effective way of dietary intervention.Therefore, our research group induced mice with Dextran Sulfate Sodium Salt (DSS), and successfully established a mouse ulcerative colitis model.
On this basis, we used HE staining (histological score), IHC, qPCR and other methods to explore the compound functional mixed strains of probiotics (probiotics for short, The ingredients include: resistant dextrin (water-soluble dietary fiber), Lactobacillus reuteri PLBK1, Lactobacillus reuteri PLBK2, Lactobacillus Grignard PLBK3, Lactobacillus acidophilus PLBK4, Bifidobacterium lactis PLBK5) and their metabolites (feces) to assist the molecular mechanism of ulcerative colitis.
The experimental results show that probiotics can significantly improve the symptoms of ulcerative colitis induced by DSS and promote the remission of enteritis.Therefore, in view of the research foundation that our animal experiments have achieved remarkable results, our research group carried out a clinical trial of human medicine in the First Affiliated Hospital of Xinxiang Medical College, and further explored the intervention of probiotics in intestinal flora to assist in the treatment of inflammation.
Clinical effect and mechanism of sexual bowel disease.
To provide new methods and new ideas for improving the cure rate of UC and IBS, reducing the recurrence rate, alleviating the physical and mental pain and economic burden of patients; At the same time, it provides new ideas for the development and utilization of functional probiotics.
It also seeks biosafety evidence for the future use of probiotics in antibiotic environment.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Minhao M Zheng, undergraduate
- Phone Number: 15651351756
- Email: mhzhbz@126.com
Study Locations
-
-
Henan
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Xinxiang, Henan, China, 453000
- Recruiting
- The First Affiliated Hospital of Xinxiang Medical College
-
Contact:
- Yongmei Y Qin
- Phone Number: 13837302139
- Email: yongmeiqin120@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of ulcerative colitis
- Clinical diagnosis of irritable bowel
- Can swallow probiotic pellets as required
Exclusion Criteria:
- indeterminate colitis,suspected IBD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic intervention group
Adjuvant treatment of UC and IBS with "Three-high Probiotics" is given to patients three times a day, one pack of 2g, lasting for 1-4 months.
|
Resistant dextrin (water-soluble dietary fiber), Lactobacillus reuteri PLBK1, Luo Lactobacillus delbrueckii, Lactobacillus griffii PLBK3, Lactobacillus acidophilus PLBK4, Bifidobacterium lactis PLBK5)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of intestinal flora
Time Frame: 4-12 weeks
|
collecting the feces of patients before and after taking medicine, and carrying out genomics analysis.
|
4-12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2022
Primary Completion (Anticipated)
January 31, 2024
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
September 9, 2022
First Submitted That Met QC Criteria
December 7, 2022
First Posted (Estimate)
December 15, 2022
Study Record Updates
Last Update Posted (Estimate)
December 15, 2022
Last Update Submitted That Met QC Criteria
December 7, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FirstAffiliatedHXinxiangMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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