Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499649
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-08
Brief Title:
Assessment of the Adjuvant Role of Dietary Supplementation of Antibiotic-tolerant Probiotics in Standard Therapy for the Eradication of Helicobacter Pylori Infection
Sponsor:
IBSA Farmaceutici Italia Srl
Organization:
IBSA Farmaceutici Italia Srl
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Clinical Study to Assess the Adjuvant Role of Dietary Supplementation of Antibiotic-tolerant Probiotics in Standard Therapy for the Eradication of Helicobacter Pylori Infection
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
Randomized double-blind placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics derived from Lactobacillus acidophilus and Bifidobacterium animalis in standard therapy for the eradication of Helicobacter pylori infection
Detailed Description:
Randomized double-blind placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics derived from Lactobacillus acidophilus and Bifidobacterium animalis in standard therapy for the eradication of H pylori infection the new strains used in this clinical trial are LAC6 BLA8 BLC6
The aim of this study is to evaluate the antibiotic adverse events decrease in subjects under the standard therapy for H Pylori eradication using probiotics compared to patients receiving the same antibiotic therapy with placebo
This study is aimed to naive patients who have never received the eradication therapy
The infection of H Pylori will be analyzed using Urea Breath Test esophagogastroduodenoscopy EGDS Histological andor culture examination on biopsy samples
The incidence and severity of the adverse events related to the eradication therapy will be assessed through the evaluation questionnaire EACTE Eventi Avversi Correlati con la Terapia Eradicante - Adverse Events correlated to Eradication Therapy
The differences of Gastrointestinal Symptom Rating Scale GSRS score will be recorded to compare the two groups patients under antibiotic therapy and probioticsplacebo treatment
The study will involve 270 patients affected by H pylori with 11 ratio of probioticplacebo treatment
Each enrolled and randomized patient should take daily
Probiotics or Placebo depending on the treatment group assigned by randomization 1 capsule twice a day before breakfast and dinner for 10 days before beginning eradication therapy After the first 10 days of dietary supplementation with probiotics or placebo the patient will be accompanied by dietary supplementation with eradication therapy duration 10 days At the end of the eradication therapy the patient will continue feeding only probiotics or placebo for a further 4 weeks with a dosage similar to that used before the beginning of the eradication therapy
On the occasion of the T1 visit after 20 days from T0 and to complete the eradication therapy the following will be carried out
completion by the medical investigator of the EACTE questionnaire on the basis of the patients reports on any adverse events occurring during the study and related to eradication therapy for the period between T0 and T1
check that the patient has taken the eradication therapy as indicated
registration of concurrent processing
recording of adverse events
During the T2 visit 4 weeks after the end of the eradication therapy the following will be carried out
urea breath test for the evaluation of HP eradication
administration by the investigator of a questionnaire for the assessment of symptoms of functional dyspepsia to be completed at T2 GSRS questionnaire
recording of adverse events
study conclusion Since this is a double-blind study neither the doctor nor the patient will be aware of the nature of dietary supplementation probiotic or placebo assigned to the patient at T0
The aim of this study is to evaluate the antibiotic adverse events decrease in subjects under the standard therapy for H Pylori eradication using probiotics compared to patients receiving the same antibiotic therapy with placebo
This study is aimed to naive patients who have never received the eradication therapy
The infection of H Pylori will be analyzed using Urea Breath Test esophagogastroduodenoscopy EGDS Histological andor culture examination on biopsy samples
The incidence and severity of the adverse events related to the eradication therapy will be assessed through the evaluation questionnaire EACTE Eventi Avversi Correlati con la Terapia Eradicante - Adverse Events correlated to Eradication Therapy
The differences of Gastrointestinal Symptom Rating Scale GSRS score will be recorded to compare the two groups patients under antibiotic therapy and probioticsplacebo treatment
The study will involve 270 patients affected by H pylori with 11 ratio of probioticplacebo treatment
Each enrolled and randomized patient should take daily
Probiotics or Placebo depending on the treatment group assigned by randomization 1 capsule twice a day before breakfast and dinner for 10 days before beginning eradication therapy After the first 10 days of dietary supplementation with probiotics or placebo the patient will be accompanied by dietary supplementation with eradication therapy duration 10 days At the end of the eradication therapy the patient will continue feeding only probiotics or placebo for a further 4 weeks with a dosage similar to that used before the beginning of the eradication therapy
On the occasion of the T1 visit after 20 days from T0 and to complete the eradication therapy the following will be carried out
completion by the medical investigator of the EACTE questionnaire on the basis of the patients reports on any adverse events occurring during the study and related to eradication therapy for the period between T0 and T1
check that the patient has taken the eradication therapy as indicated
registration of concurrent processing
recording of adverse events
During the T2 visit 4 weeks after the end of the eradication therapy the following will be carried out
urea breath test for the evaluation of HP eradication
administration by the investigator of a questionnaire for the assessment of symptoms of functional dyspepsia to be completed at T2 GSRS questionnaire
recording of adverse events
study conclusion Since this is a double-blind study neither the doctor nor the patient will be aware of the nature of dietary supplementation probiotic or placebo assigned to the patient at T0
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?:
None