Trial · NCT01593592
Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients
NCT01593592, Not applicable, Completed, Zagazig University; results first posted 2015-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients. Trials, record NCT01593592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01593592
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients
- NCT number
- NCT01593592
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 70 participants, actual
- Lead sponsor
- Zagazig University
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Lactobacillus reuteri, Placebo, Omeprazole, Amoxicillin, Clarithromycin
- First posted
- 2012-05-08
- Last updated
- 2015-08-17
- Results first posted
- 2015-08-17
- Limitations and caveats
- no limitations
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | 4 weeks therapy | H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy. |
| Secondary | Severe Adverse Effects to the Used Medications and Dietary Supplements. | 4 weeks | |
| Secondary | The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | 8 weeks | Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | 4 weeks therapy | It is assessment of all the 70 participants about H pylori eradication status | participants | NUMBER |
| SECONDARY | Severe Adverse Effects to the Used Medications and Dietary Supplements. | 4 weeks | percentage of participants | NUMBER | |
| SECONDARY | The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | 8 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | Control Group | 23 | participants | ||
| Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | Lactobacillus Reuteri Group | 26 | participants | ||
| Severe Adverse Effects to the Used Medications and Dietary Supplements. | Control Group | 0 | percentage of participants | ||
| Severe Adverse Effects to the Used Medications and Dietary Supplements. | Lactobacillus Reuteri Group | 0 | percentage of participants | ||
| The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | Control Group | 0 | participants | ||
| The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | Lactobacillus Reuteri Group | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Group | 35 | |
| Overall Study | STARTED | Lactobacillus Reuteri Group | 35 | |
| Overall Study | COMPLETED | Control Group | 35 | |
| Overall Study | COMPLETED | Lactobacillus Reuteri Group | 35 | |
| Overall Study | NOT COMPLETED | Control Group | 0 | |
| Overall Study | NOT COMPLETED | Lactobacillus Reuteri Group | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Galactorrhea | Reproductive system and breast disorders | Lactobacillus Reuteri Group | 0 | 35 | |
| other | Galactorrhea | Reproductive system and breast disorders | Control Group | 1 | 35 | |
| other | Taste disorders | Gastrointestinal disorders | Lactobacillus Reuteri Group | 2 | 35 | |
| other | Taste disorders | Gastrointestinal disorders | Control Group | 8 | 35 | |
| other | Diarrhea | Gastrointestinal disorders | Lactobacillus Reuteri Group | 1 | 35 | |
| other | Diarrhea | Gastrointestinal disorders | Control Group | 10 | 35 | |
| other | Distension | Gastrointestinal disorders | Lactobacillus Reuteri Group | 5 | 35 | |
| other | Distension | Gastrointestinal disorders | Control Group | 4 | 35 | |
| other | Vomiting | Gastrointestinal disorders | Lactobacillus Reuteri Group | 2 | 35 | |
| other | Vomiting | Gastrointestinal disorders | Control Group | 2 | 35 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lactobacillus Reuteri Group | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Lactobacillus Reuteri Group | 10 | 35 |
| Total, other adverse events | Control Group | 25 | 35 |
| Total, serious adverse events | Lactobacillus Reuteri Group | 0 | 35 |
| Total, serious adverse events | Control Group | 0 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lactobacillus Reuteri Group vs Control Group: The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | Trial comparisons |
| Lactobacillus Reuteri Group vs Control Group: Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | Trial comparisons |
| Lactobacillus Reuteri Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01593592
GET https://conductscience.org/api/trials/v1/NCT01593592/registered