Proton Pump Inhibitors and Gastrointestinal Symptoms

NCT02054455 | Completed Phase 4

• 1 other identifier: PPI-SIBO-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the potential protective effect of Lactobacillus paracasei subspecies paracasei F19 administration on bowel symptom onset in patients with gastro-esophageal reflux disease at long-term PPI treatment.

Conditions

Gastrointestinal Symptoms; Small Intestinal Overgrowth

Keywords

PPI; SIBO; LP-F19

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal symptom's assessment

  The questionnaire used to assess symptoms was built-up according to a four-point Likert scale evaluating both frequency (0 = never, 1 = \< 1 episode/week; 2 = \< 3 episodes/week; 3 = \> 3 episodes/week; 4 = daily episodes) and severity (0 = absent, 1 = mild i.e. not interfering with the daily activities, 2 = moderate i.e. limiting the daily activities, and 3 = severe i.e. hampering the daily activities) of each symptom during the previous 6 months, at baseline and during the last month at every 4-week checkpoints. According to an arbitrary index, symptoms were considered significant when interfering with daily activities (i.e., mean total score, frequency plus severity, \>4).

  up to 6 months

Secondary Outcomes (1)

• Bowel habit assessment

  up to 6 months

Study Arms (4)

PPI and placebo

PLACEBO COMPARATOR

Patients will receive PPI and placebo for 3 days/week for 6 months

Dietary Supplement: Placebo

PPI and Lactobacillus paracasei F19

ACTIVE COMPARATOR

Patients will receive Lactobacillus paracasei F19 in a dose of 25x10E9 live bacterial cells for 3 days/week for 6 months

Dietary Supplement: Lactobacillus paracasei F19

PPI and Lactobacillus paracasei F19 cross-over 1

ACTIVE COMPARATOR

Patients will receive placebo 3 days/week for the first three months and Lactobacillus paracasei F19 in a dose of 25x10E9 live bacterial cells for 3 days/week for the following three months

Dietary Supplement: Lactobacillus paracasei F19; Dietary Supplement: Placebo

PPI and Lactobacillus paracasei F19 cross-over 2

ACTIVE COMPARATOR

Patients will receive Lactobacillus paracasei F19 in a dose of 25x10E9 live bacterial cells for 3 days/week for the first three months and placebo 3 days/week for the following three months

Dietary Supplement: Lactobacillus paracasei F19; Dietary Supplement: Placebo

Interventions

Lactobacillus paracasei F19 DIETARY_SUPPLEMENT

25x10E9 live bacterial cells for 3 days/week for 6 months

PPI and Lactobacillus paracasei F19; PPI and Lactobacillus paracasei F19 cross-over 1; PPI and Lactobacillus paracasei F19 cross-over 2

Placebo DIETARY_SUPPLEMENT

Placebo will consist of a preparation similar to that of probiotic but with no added microorganisms.

PPI and Lactobacillus paracasei F19 cross-over 1; PPI and Lactobacillus paracasei F19 cross-over 2; PPI and 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:

• recent onset of typical reflux symptoms (heartburn and regurgitation).

You may not qualify if:

• age \<18 or \>70 yrs
• pregnancy or breast-feeding
• evidence of major concomitant diseases (i.e., tumors, cardiovascular disorders and hepatic and/or renal failure)
• use of PPIs or H2-antagonists, non-steroidal anti-inflammatory drugs (NSAIDs) or antibiotics in the previous 3 months
• presence of Helicobacter pylori (H. pylori) infection
• erosive esophagitis
• presence of bowel symptoms such as bloating, flatulence, abdominal pain, diarrhea and constipation in the last 6 months or irritable bowel syndrome (IBS) according to Rome III criteria.

Sponsors & Collaborators

• Federico II University: lead
• University of Catanzaro: collaborator
• Ospedale Nuovo Regina Margherita di Roma Dr. Salvatore Campo: collaborator

Study Sites (1)

University Federico Ii

Naples, 80131, Italy

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR OF GASTROENTEROLOGY

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: February 4, 2014
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

IT (1)