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RecruitingNCT05652621Updated Dec 15, 2022

Efficacy of Probiotics in Patients With IBD

An interventional study of probiotics in Ulcerative Colitis and Irritable Bowel Syndrome, sponsored by The First Affiliated Hospital of Xinxiang Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-15.

Sponsored by The First Affiliated Hospital of Xinxiang Medical College · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Ulcerative Colitis
  • Irritable Bowel Syndrome
03

In context

Colitis, Ulcerative

1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

The First Affiliated Hospital of Xinxiang Medical College is the lead sponsor of 42 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of ulcerative colitis
  • Clinical diagnosis of irritable bowel
  • Can swallow probiotic pellets as required

Exclusion criteria

Exclusion Criteria:

  • indeterminate colitis,suspected IBD
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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.

    Dietary Supplement: probiotics

Interventions

  • Dietary supplementprobiotics

    Resistant dextrin (water-soluble dietary fiber), Lactobacillus reuteri PLBK1, Luo Lactobacillus delbrueckii, Lactobacillus griffii PLBK3, Lactobacillus acidophilus PLBK4, Bifidobacterium lactis PLBK5)

06

What researchers measure

Primary outcomes

  1. Changes of intestinal flora

    collecting the feces of patients before and after taking medicine, and carrying out genomics analysis.

    Time frame: 4-12 weeks

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Xinxiang Medical College
    Xinxiang, Henan 453000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05652621
Lead sponsor
The First Affiliated Hospital of Xinxiang Medical College
Responsible party
Sponsor
First posted
Dec 15, 2022
Start date
Jul 31, 2022
Primary completion
Jan 31, 2024 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 15, 2022

Study contacts

Minhao M Zheng, undergraduate
Contact
mhzhbz@126.com
15651351756

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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