Efficacy and Safety of Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori

NCT01969331 | Completed Phase 4

• 1 other identifier: JGL/02/09
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to establish efficacy and safety of Normia® probiotic, used as an add-on therapy in treatment of H. Pylori infection with the standard triple therapy approach. The primary objective in the study is determination of efficacy of Normia® probiotic as a supportive therapy in achieving a higher percentage of eradication of H. Pylori. The secondary objectives are to assess:

• Safety profile of Normia® probiotic in everyday use, e.g. reduction in number of side-effects and better compliance to the eradication therapy
• Safety and efficacy of Normia® probiotic in different demographic subgroups

Conditions

Helicobacter Pylori Infection

Keywords

Gastritis; Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• Percentage of eradication of H.Pylori infection with Normia® probiotic as a additional therapy to standard triple therapy regimen

  Duration of participation in the study will depend on the duration of therapy prescribed by the attending physician. The exact type of the basic (triple) therapy prescribed to each subject is at the discretion of the physician. Assuming standard therapy regimes for this indication, the shortest possible participation in the study will be as follows: * 7 days of initial triple therapy, followed by * 21 days of PPI therapy only, followed by * 14 days +/- 2 days to the follow up visit. Therefore, study participation will take between 40 and 44 days.

  40-44 days

Secondary Outcomes (1)

• Reducing the number of adverse events for H. pylori eradication triple therapy using Normia® probiotic as a supportive therapy

  40-44 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171) Placebo as an addition to standard H. Pylori eradication therapy 7 days of initial therapy (2 antibiotics + PPI), followed by 21 days of PPI only therapy. Two weeks after the end of PPI therapy subjects are seen at the follow up visit.

Dietary Supplement: Placebo

Normia

ACTIVE COMPARATOR

Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12® Normia® probiotic as an addition to standard H. Pylori eradication therapy 7 days of initial therapy (2 antibiotics + PPI), followed by 21 days of PPI only therapy. One capsule twice per day/14 days Two weeks after the end of PPI therapy subjects are seen at the follow up visit.

Dietary Supplement: Normia

Interventions

Normia DIETARY_SUPPLEMENT

One capsule twice a day/14 days

Also known as: Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12®

Normia

Placebo DIETARY_SUPPLEMENT

maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed H. Pylori infection.
• Otherwise healthy subjects taking H. pylori eradication therapy.
• Age above 16 years.
• Male and female subjects.
• Subject who provided written informed consent prior to undergoing any study procedure.

You may not qualify if:

• Pregnancy or lactation.
• Severe diseases such as malignant diseases, severe renal/liver impairment, HIV infection etc.
• Subject who is not mentally capable of adhering to the protocol.
• Drug addiction or alcoholism.
• Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
• Subjects participating in any other clinical trial.

Sponsors & Collaborators

• Goran Hauser: lead
• Jadran Galenski laboratorij d.d.Rijeka: collaborator

Study Sites (1)

University Hospital Rijeka

Rijeka, Rijeka, 51000, Croatia

Location

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Goran Hauser, MD,PhD

  UH Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Goran Hauser MD, PhD

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 25, 2013
• Study Start: December 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

CR (1)