Crohn's Disease Clinical Trials

Find Crohn's Disease Clinical Trials Near You

Evaluating the Efficacy of Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease (IBD): An Interventional Trial

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Design: * Sample Size: 150 participants * Study Location: Department of Gastroenterology Intervention Description: A total of 150 eligible participants will be randomly assigned to three groups (n = per group). * The Placebo Group will receive standard IBD treatment combined with oral RO water, one ampoule per dose, three times daily for 30 consecutive days. * The COLON Group will receive standard IBD treatment combined with LiveSpo® COLON, one ampoule per dose, three times daily for 30 consecutive days * The DIA30-COLON Group will receive standard IBD treatment combined with LiveSpo® DIA30, one ampoule per dose, three times daily for the first 14 days, followed by LiveSpo® COLON, one ampoule per dose, three times daily for the next 16 days. All participants in the three groups will receive blinded, coded study products. Patients in all groups will follow the standard IBD treatment regimen of the hospital and use the assigned study products throughout the study period. Caregivers or clinical staff will monitor the health status of participants and record relevant information in their medical records. During the study, participants will be instructed not to use any additional probiotic products or solutions containing similar components. Study Duration: 12 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Age 18 to 65 years.

• Confirmed diagnosis of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, according to the routine diagnostic procedures of Hanoi Medical University Hospital.

• Receiving examination and treatment at Hanoi Medical University Hospital (including both inpatients and outpatients), with a minimum treatment or follow-up duration of 14 days

• Willing and able to provide written informed consent.

Locations
Other Locations
Viet Nam
Department of Gastroenterology
RECRUITING
Hà Nội
Contact Information
Primary
Anh N Tran, Assoc.Prof.
anhtn69@yahoo.com
(84)904831512
Backup
Chi T Nguyen, MD, Specialist II
chint0366@hmuh.vn
(84)912153567
Time Frame
Start Date: 2026-09-04
Estimated Completion Date: 2027-10-15
Participants
Target number of participants: 150
Treatments
Placebo_comparator: Placebo
Participants in the Placebo Group will receive the hospital's standard IBD treatment regimen combined with oral RO water as placebo, one 5 mL ampoule per dose, three times daily for 30 consecutive days. the standard IBD treatment regimen may include stepwise medical therapy with 5-aminosalicylic acid (5-ASA), corticosteroids during disease flares, immunomodulators, or biologic agents when clinically indicated. Supportive care, including antibiotics when infection is suspected or confirmed, fluid and electrolyte replacement, and nutritional support, will be applied consistently across groups. All standard treatments and concomitant medications used during the study period will be recorded. Laxatives and non-study probiotics will not be used during the intervention period.
Experimental: COLON
Participants will receive the same standard IBD treatment regimen as the Placebo Group, combined with LiveSpo® COLON, one 5 mL ampoule per dose, three times daily for 30 consecutive days.
Experimental: DIA30-COLON
Participants will receive the same standard IBD treatment regimen as the Placebo Group, combined with LiveSpo® DIA30, one 5 mL ampoule per dose, three times daily for the first 14 days, followed by LiveSpo® COLON, one 5 mL ampoule per dose, three times daily for the next 16 days.
Sponsors
Leads: Anabio R&D
Collaborators: Hanoi Medical University

This content was sourced from clinicaltrials.gov