Helicobacter pylori eradication with Probiotic Lactobacillus casei rhamnosus LCR35 Alone or in Combination with Antibiotic Therapy

Phase 1

• Conditions: Helicobacter pylori infection; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-005111-14-AT
• Lead Sponsor: Kepler Universitätsklinikum, Medcampus III, Klinik für Interne 2

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-09
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1. Signed the informed consent form
2. Men or women between 18 and 70 years
3. Histologically-proven Helicobacter pylori-associated gastritis prior to screening
4. Helicobacter pylori colonization confirmed by stool antigen test
5. BMI between 18.5 and 35, inclusively
6. Negative anamnesis for current pregnancy or breast-feeding at Screening and Baseline
7. Women at child-bearing potential are advised to use an effective method of birth control
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 440
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of previous Helicobacter pylori eradication, unless deemed to be irrelevant by the principal investigator (i.e. in cases of a long gap between first eradication and current positive H. pylori result, making reinfection the most propable explanation).
2. Known intolerances or allergies to any of the study drugs
3. Severe endoscopic manifestation, such as hemorrhagic gastritis and gastric or duodenal ulcers
4. Barrett’s oesophagus, high-grade dysplasia, or any kind of malignancy in endoscopy
5. Use of non-steroidal anti-inflammatory drugs (NSAIDS, exept acetylsalicylic acid if daily dose is
= 100mg per day), antibiotics, pre- or probiotics within 4 weeks prior to enrollment
6. History of major abdominal surgery in the past (appendectomy excluded)
7. History of regular excessive alcohol intake (>40g/d for women, >80g/d for men) or drug abuse
(steroid-abuse included) within the past 12 months
8. History of lactose intolerance
9. Any substantial organ impairment including severe or unstable cardiopulmonary, renal, liver,
endocrine, or neuro-psychiatric disease
10. History of cancer in the last five years
11. History of chronic infectious or immune-deficient diseases
12. Existing or planned pregnancy or breast-feeding
13. Difficulty to understand the treatment or to report disease symptoms and adverse effects
14. Participation in another clinical trial and having received another IMP within the last 30 days prior
to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified