Supplementation With L. Reuteri in H. Pylori Infected Adults

NCT01449500 | Unknown

• 1 other identifier: CSUB0028
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether simultaneous use of L. reuteri ProGastria and proton pump inhibitors can eradicate H. pylori in humans in the absence of antibiotics.

Conditions

Dyspepsia; H. Pylori Infection

Keywords

Dyspeptic H.pylori-infection

Outcome Measures

Primary Outcomes (1)

• Increase in the number of subjects with treatment success after 28 days of treatment with omeprazole + L. reuteri compared to those given omeprazole + placebo.

  Treatment success is defined as the absence of H. pylori infection as shown by a significant reduction in symptoms on Day 28 and by the absence of H. pylori on gastric biopsy at Day 28.

  28 days

Secondary Outcomes (1)

• Fewer patients in the L. reuteri treatment success group with demonstrated presence of H. pylori infection, measured as UBT on Day 90 compared to the placebo treatment success group

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

L. reuteri

ACTIVE COMPARATOR

L. reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. Intervention: Dietary Supplement: L. reuteri DSM 17938 and ATCC PTA 6475

Dietary Supplement: L. reuteri

Interventions

L. reuteri DIETARY_SUPPLEMENT

Chewable tablet, one tablet/day for 28 days

Also known as: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

L. reuteri

Placebo DIETARY_SUPPLEMENT

Chewable tablet, one tablet per day for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18-70 years
• Infection with H. pylori defined by endoscopic examination with biopsy H. pylori staining
• Non-ulcer dyspepsia
• Absence of other pathology as shown by basic clinical laboratory tests (blood and urine) as well as abdominal ultrasound
• No earlier eradication therapy for H. pylori infection
• Written informed consent
• Stated availability throughout the entire study period
• Mental ability to understand and willingness to fulfil all the details of the protocol.

You may not qualify if:

• Duodenal or gastric ulcer
• MALT lymphoma
• Gastric resection (at any time)
• First level relatives of gastric cancer patients
• Absence of GI symptoms
• Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
• Pregnancy
• Participation in other clinical trials

Sponsors & Collaborators

• Lama Medical Care s.r.o.: lead
• BioGaia AB: collaborator

Study Sites (1)

Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5

Bratislava, 81107, Slovakia

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ladislav Kuzela, MD

  Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5, 811 07, Bratislava, Slovakia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ladislav Kuzela, MD

CONTACT

+42 1257 108 511; kuzela@thalion.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 10, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 10, 2011

Record last verified: 2011-10

Locations

SL (1)