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Proton Pump Inhibitors and Gastrointestinal Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054455
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Collaborators:
University of Catanzaro
Ospedale Nuovo Regina Margherita di Roma Dr. Salvatore Campo
Information provided by (Responsible Party):
NARDONE GERARDO, Federico II University

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Symptoms Small Intestinal Overgrowth Dietary Supplement: Lactobacillus paracasei F19 Dietary Supplement: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Protective Effects of Probiotic Administration on SIBO Development and Bowel Symptom Onset in GERD Patients at Long-term PPI Treatment: a Randomized Controlled Cross-sectional Study
Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: PPI and placebo
Patients will receive PPI and placebo for 3 days/week for 6 months
Dietary Supplement: Placebo
Placebo will consist of a preparation similar to that of probiotic but with no added microorganisms.

Active Comparator: PPI and Lactobacillus paracasei F19
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
25x10E9 live bacterial cells for 3 days/week for 6 months

Active Comparator: PPI and Lactobacillus paracasei F19 cross-over 1
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
25x10E9 live bacterial cells for 3 days/week for 6 months

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

Active Comparator: PPI and Lactobacillus paracasei F19 cross-over 2
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
25x10E9 live bacterial cells for 3 days/week for 6 months

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




Primary Outcome Measures :
  1. Gastrointestinal symptom's assessment [ Time Frame: up to 6 months ]
    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).


Secondary Outcome Measures :
  1. Bowel habit assessment [ Time Frame: up to 6 months ]
    Subjects will record their bowel habits on validated diary cards, including every single stool and stool consistency. Stool consistency will be defined according to the Bristol Stool Form Scale (BSFS). Diary cards will be returned every four weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054455


Locations
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Italy
University Federico Ii
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
University of Catanzaro
Ospedale Nuovo Regina Margherita di Roma Dr. Salvatore Campo

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Responsible Party: NARDONE GERARDO, ASSOCIATE PROFESSOR OF GASTROENTEROLOGY, Federico II University
ClinicalTrials.gov Identifier: NCT02054455    
Other Study ID Numbers: PPI-SIBO-01
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Keywords provided by NARDONE GERARDO, Federico II University:
PPI
SIBO
LP-F19