Efficacy of Probiotics in Patients With IBD

NCT05652621 | Recruiting

• 1 other identifier: FirstAffiliatedHXinxiangMC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes of intestinal flora

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

  4-12 weeks

Study Arms (1)

Probiotic intervention group

EXPERIMENTAL

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

probiotics DIETARY_SUPPLEMENT

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

Probiotic intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• indeterminate colitis,suspected IBD

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, 453000, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Irritable Bowel Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Colonic Diseases, Functional

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Minhao M Zheng, undergraduate

CONTACT

15651351756; mhzhbz@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: December 15, 2022
• Study Start: July 31, 2022
• Primary Completion: January 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2022

Record last verified: 2022-07

Locations

CN (1)