Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT03722433
Status:
UNKNOWN
Last Update Posted:
2018-10-31
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics in the Reduction of Adverse Effects and Dysbiosis of H. Pylori Eradication
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
The Efficacy of Probiotic Supplementation in the Reduction of Adverse Effects and Dysbiosis of Helicobacter Pylori Eradication Therapy - A Double Blind, Multi-center Randomized, Placebo Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators aimed to assess the effect of probiotic supplementation with Vigiis 101-LAB during H. pylori eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Detailed Description:
Backgroud: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and the recurrence rate of peptic ulcer disease. However, the adverse effects, such as diarrhea and abdominal pain occurred in about 20-30% of patient during eradication therapies for H. pylori. Dysbiosis of the gut microbiota might contribute to the adverse effects.
Aims: Therefore, the investigators aimed to assess the efficacy of probiotic supplementation during the eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Methods:
This will be a double-blind, placebo controlled, multi-center randomized trial. 200 patients with H. pylori infection naïve to eradication therapy will be enrolled.
Before First Line Treatment: Any two positive of CLO test, histology, serology and culture or a positive UBT will be considered as H. pylori infected.
After First Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after 14-day sequential therapy
Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after14-day sequential therapy
Interventions: First line therapy: eligible patients will be randomized into one of the two groups.
Group (A): probiotic plus 14-day sequential therapy D1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Group (B): placebo plus 14-day sequential therapy D1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Follow-up
1. The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut flora
2. The body weight, waist and hip circumference and serum lipid profile, sugar, and HBA1C levels will be collected before , and 2 and 8 weeks and 1 year after eradication therapy
3. Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of antibiotics. Mutations in 23S rRNA will also be determined by PCR followed by direct sequencing
Outcome Measurement:
Primary End Point: Incidence of adverse effects in the first line therapy in the two treatment groups
Secondary End Point:
1. Eradication rates in the first line treatment in the two treatment groups
2. Changes of gut microbiota in the two treatment groups
3. Antibiotic resistance of gut flora after first line treatments in the two treatment groups
4. Re-infection rate one year after eradication therapy
Aims: Therefore, the investigators aimed to assess the efficacy of probiotic supplementation during the eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Methods:
This will be a double-blind, placebo controlled, multi-center randomized trial. 200 patients with H. pylori infection naïve to eradication therapy will be enrolled.
Before First Line Treatment: Any two positive of CLO test, histology, serology and culture or a positive UBT will be considered as H. pylori infected.
After First Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after 14-day sequential therapy
Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after14-day sequential therapy
Interventions: First line therapy: eligible patients will be randomized into one of the two groups.
Group (A): probiotic plus 14-day sequential therapy D1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Group (B): placebo plus 14-day sequential therapy D1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Follow-up
1. The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut flora
2. The body weight, waist and hip circumference and serum lipid profile, sugar, and HBA1C levels will be collected before , and 2 and 8 weeks and 1 year after eradication therapy
3. Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of antibiotics. Mutations in 23S rRNA will also be determined by PCR followed by direct sequencing
Outcome Measurement:
Primary End Point: Incidence of adverse effects in the first line therapy in the two treatment groups
Secondary End Point:
1. Eradication rates in the first line treatment in the two treatment groups
2. Changes of gut microbiota in the two treatment groups
3. Antibiotic resistance of gut flora after first line treatments in the two treatment groups
4. Re-infection rate one year after eradication therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: